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Strategies To Avoid Replication Failure

The document discusses the long-term negative effects of poor parenting on children's behavioral health and the importance of evidence-based interventions (EBIs) like the Strengthening Families Program (SFP) in mitigating these issues. It highlights the challenges of replication failure in EBIs, providing six strategies to enhance implementation and maintain program integrity. The authors emphasize the need for accurate reporting of outcomes to foster trust in EBIs and improve public health initiatives.

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0% found this document useful (0 votes)
6 views34 pages

Strategies To Avoid Replication Failure

The document discusses the long-term negative effects of poor parenting on children's behavioral health and the importance of evidence-based interventions (EBIs) like the Strengthening Families Program (SFP) in mitigating these issues. It highlights the challenges of replication failure in EBIs, providing six strategies to enhance implementation and maintain program integrity. The authors emphasize the need for accurate reporting of outcomes to foster trust in EBIs and improve public health initiatives.

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CHRISTEROP
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Evaluation & the Health Professions

1-34
ª The Author(s) 2018
Strategies to Avoid Reprints and permission:
sagepub.com/journalsPermissions.nav
Replication Failure DOI: 10.1177/0163278718772886
journals.sagepub.com/home/ehp

With Evidence-
Based Prevention
Interventions: Case
Examples From
the Strengthening
Families Program

Karol L. Kumpfer1, Lawrence M. Scheier2 ,


and Jaynie Brown3

Abstract
Research has found disturbing long-term effects of poor parenting on
children’s behavioral health including addiction, delinquency, depression/
anxiety, and poorer health as adults. Poor parenting practices thus con-
tribute substantially to the health crisis in America. However, skilled, nur-
turing parents, or caretakers can help youth avoid these developmental
problems. A number of family and parenting evidence-based interventions

1
Strengthening Families Program, LLC, Salt Lake City, UT, USA
2
LARS Research Institute, Inc., Scottsdale, AZ, USA
3
Strengthening Families Program, Salt Lake City, UT, USA

Corresponding Author:
Karol L. Kumpfer, Strengthening Families Program, LLC, 817 East 17th Avenue, Salt Lake City,
UT 84103, USA.
Email: [email protected]
2 Evaluation & the Health Professions XX(X)

(EBIs) that teach parenting skills are now available for dissemination.
Unfortunately, replications of EBIs do not always produce the original
positive results. Organizations that seek to use family EBIs to improve
parenting and family skills need to avoid practices that create replication
failure. We examine several possible factors that contribute to replication
failure using examples from five replications of the EBI “Iowa Strengthening
Families Program for ages 10–14.” We then share six strategies conducive
to avoid replication failures including (1) choosing the right program and
implementation strategy for the population, (2) administering the right
“dosage,” (3) choosing and properly training implementers, (4) maintaining
program integrity and adherence, (5) ensuring cultural sensitivity, and (6)
ensuring accurate and complete reporting of evaluation results. These
guidelines can advance prevention science to meet the demands of a
growing public health agenda.

Keywords
family-based programs, evaluation, replication failure, implementation, pro-
gram fidelity

There is now concrete evidence from long-term randomized control trials


(RCTs) that family evidence-based interventions (EBIs) can produce
upward of 50% reductions in various behavioral health disorders (e.g.,
Dishion et al., 2008) and continued evidence that strong, resilient families
can avoid adverse developmental outcomes (e.g., Kumpfer, Magalhaes, &
Xie, 2017). Notwithstanding, we still lack hard and fast rules about imple-
menting EBIs at the ground level where agencies and organizations face a
crisis in fostering the health and well-being of America. Indeed, and despite
their very best efforts at taking family-based programs to scale, there has
recently been a spate of replication failures reported in the literature. Repli-
cation failure, one of the several translational science challenges, arises
when EBIs disseminated and evaluated in tightly controlled efficacy trials
are later delivered by independent agencies and research teams under less
controlled effectiveness trial conditions and are unable to replicate the
original efficacy trial outcomes.
This compendium of negative or null findings may be partly responsi-
ble for the crisis in replication that is afflicting psychology (Maxwell,
Lau, & Howard, 2015) and that extends to prevention science (Valentine
et al., 2011). Maxwell, et al. (2015) cite several major reasons for
Kumpfer et al. 3

replication failure as investigators seeking to control Type I error, includ-


ing but not limited to using different procedures and following different
protocols, unique samples, varying measurements, and low powered stud-
ies. To satisfy statistical requirements, replications require a much larger
sample than the original study, which rarely occurs. Also sampling varia-
bility in effect sizes can lead to underpowered replication samples. Con-
fidence intervals may be superior to point estimates of effect sizes in this
instance. Any number of factors can contribute to Type II errors (conclud-
ing an effective intervention does not work) including procedural varia-
tion in implementation and evaluation errors. Replication failure can also
include omissions by the researcher to report on all the facets of family
change documented in the intervention—and selectively focus on only
one or two outcomes.
In this article, we address several issues of paramount importance that
we believe are related to replication failure as it specifically affects family-
based parenting skills and youth drug prevention programs. We first intro-
duce readers to a brief history of the Strengthening Families Program (SFP),
a family-based parenting skills training program that targets a wide range of
mental and behavioral disorders in children and youth including drug use.
The program is generally administered through community agencies and
can also involve the participation of schools, clinics, and various commu-
nity partnerships. It is for this reason that it provides an excellent backdrop
against which we can dissect the many reasons for replication failure
including carefully examining implementation concerns and the myriad
of ways problems in program delivery can affect program outcomes.
We then share six program-based strategies that agencies and evaluators
can engage to avoid replication failures.1 The six strategies we feel deserve
the most attention include (1) matching program type to target audience
(i.e., implementing the universal seven-session SFP with high risk families
when the selective 10 or 14 weeks SFP likely would have worked better);
(2) administering the right dosage (i.e., avoiding cutting dosage by elim-
inating boosters); (3) properly training implementers that are invested in the
program goals (i.e., ensuring buy-in and high implementation enthusiasm);
(4) maintaining program integrity by keeping intact core components (i.e.,
including all key active ingredients) and adhering to the program delivery
format (i.e., keeping whole families intact for trainings); (5) culturally
tailoring the program (i.e., considering different cultural mores that influ-
ence family dynamics); and (6) using the right evaluation methodology (i.e.,
design, assessment instruments, and statistical analysis). We conclude our
discussion by highlighting the importance of publishing an unbiased and
4 Evaluation & the Health Professions XX(X)

full report on an EBI’s outcomes and not cherry picking or casting aside
negative ones. This will help avoid replication failure and unfairly discou-
rage others from using an evidence-based program that might fill an
agency’s needs.

Historical Antecedents of SFP


The SFP is a unique family-based prevention intervention that combines
parenting, youth, and family skills training to reduce adolescent behavioral
health disorders including delinquency and the use of alcohol and drugs.
The multicomponent program is highly interactive and involves 1-hr ses-
sions earmarked for parents to improve their parenting skills and separately
for youth to provide skills that reduce vulnerability to drug use and other
behavioral problems (for a review of the logic model and program active
ingredients, see Kumpfer, Magalhães, Whiteside, & Xie, 2016). At the
conclusion of the separate training sessions, parents and youth come
together for another hour of nondirective play to practice and rehearse
newly acquired skills, view videotapes exemplifying positive behavior,
structure opportunities including role-playing to achieve family harmony,
and receive positive feedback from implementation staff.2
Briefly, the program blends family systems theory (Forehand & McMa-
hon, 1981; Guerney, Coufal, & Vogelson, 1981) and the social ecology
domain model of risk and resilience (Kumpfer & Turner, 1990–1991) to
construe youth drug use as part of a “family affair,” contextually bound by
family dynamics, peer influences, and the social ecology of the home. Using
techniques drawn from therapeutic traditions (e.g., Bowen, 1991), social
learning theory (e.g., Bandura, 1977), and clinical coaching and skills train-
ing methods (e.g., Patterson, 1982), parents are taught effective parenting
strategies including how to communicate with their child, setting bound-
aries and limits (controls and restrictions), appropriately reward their child
in a nonpunitive environment, and different ways to bond with their chil-
dren and increase family cohesion. Following program exposure parents
should be better teachers, more empathic, better listeners, and more under-
standing of their child’s world. Children receive training in social and
personal competency skills that will help them refuse drug offers and
improve their social–emotional regulation, problem-solving, and effective
communication. The goal for children is to increase opportunities for iden-
tification and bonding with “positive peers, adults, authority figures, and
role models” (Kumpfer et al., 2016, p. 70) through greater self-regulation,
better conflict and stress management, and learning ways to handle peer
Kumpfer et al. 5

pressure. To be clear, SFP is not a ““one-size-fits-all”” intervention, rather


the program has different age versions complementing developmental peri-
ods from childhood through high school (SFP 0–3 years, SFP 3–5, SFP 6–
11, SFP 12–16, and SFP 7–17) and is adaptive to different child risk levels.

Early Evidence
DeMarsh and Kumpfer (1985) and Kumpfer and DeMarsh (1985) reported
on the first trial conducted with a 14-session version of SFP with children
aged 6–11. The 4-year trial, funded in 1982 by the National Institute of
Drug Abuse, used a four-condition dismantling design randomly assigning
chemically dependent parents3 in treatment and their children either to
receive the full SFP, the parent training only, parent training plus a child’s
skills component, or no additional treatment. The Utah state substance
abuse agency subcontracted recruitment to drug treatment agencies who
relied on drug counselors to obtain family participation. The outcome eva-
luation focused on parents’ discipline and punishment practices, parent–
child communication, and family environment (i.e., harmony) and included
a wide range of child behaviors (internalizing and externalizing, delin-
quency, competence, peer relations, and parent bonding). Parents and chil-
dren assigned to the full condition offering skills training to both parent and
child fared better compared to the remaining three conditions. These
improvements included fewer problems reported by parents handling their
child with greater awareness of child management strategies. Parents also
reported their children were more manageable, showed improvements
around the home with fewer behavioral problems compared to their same
age peers. Consistent with a reasoned action approach, children reported
fewer intentions to smoke and drink, which are important intermediate
measures that presage behavior.
Since its initiation, SFP has been tested in 12 RCTs—six conducted with
independent research teams (Brody et al., 2006; Brook, McDonald, & Yan,
2012; Coatsworth et al., 2014; Gottfredson et al., 2006; Maguin et al., 2004;
Puffer, Annan, Sim, Salhi, & Betancourt, 2017) all producing favorable
intervention effects by reducing risk and increasing protective factors that
are etiologically linked with alcohol, tobacco, and drug use. The program
also improves mental health outcomes, increases personal resilience,
reduces delinquency, violence, and aggression and has positive effects on
academic performance by reducing school behavior problems including
early dropout (Kumpfer, Xie, & Hu, 2011). Importantly, SFP has been
shown to work well with all types of families—not just those that are
6 Evaluation & the Health Professions XX(X)

considered “high risk” including rural (Kumpfer, Alvarado, Tait, & Turner,
2002; Marek, Brock, & Sullivan, 2006) and urban settings (Aktan, Kump-
fer, & Turner, 1996) and with different age groups (Kumpfer, Greene,
Allen, & Miceli, 2010).
Subsequently, a shorter seven-session “universal” version with four
booster sessions was developed for youth aged 10–14. This downsized
version was developed as part of a university–community collaborative
partnership implementing SFP with rural families from Iowa. The modifi-
cation was instituted for essentially two reasons: First, families recruited for
the study found it difficult to travel long distances and attend 14 weeks of
classes, increasing attrition (only 20% of the total families recruited parti-
cipated in SFP 10–14), and second, the Iowa SFP recruited whole 6th grade
classrooms through schools to attend the SFP family classes. As a result, the
universal program required programmatic changes to reflect the lower risk
levels of these families (Kumpfer, Molgaard & Spoth, 1996; Molgaard,
Spoth, & Redmond, 2000).4 Details on the revised SFP 10–14 curriculum
can be found at the Iowa State University Extension (http://www.extensio
n.iastate.edu/sfp/).

So Why the Crises of Replication Failure?


As previously mentioned, the problem of replication failure has become a
topic of concern not only for psychology in general but also more specif-
ically for prevention science (e.g., Elliott & Mihalic, 2004; Valentine et al.,
2011). Replication is both the bane of a scientist’s existence and yet the very
foundation on which science rests. Findings in one laboratory must be
objectively verified in an independent trial, lest subjectivity, and the
thought of “tinkering” (or selective reporting) enter the discussion. For
prevention science, the discussion over replication has fueled debate over
the supposed efficacy of studies when they leave the laboratory and hit the
streets. There are many reasons for replication failure, and these make up
the balance of this discussion.
In a recent article, Gorman (2017) suggested that regression to the mean,
flexible data analysis, and selective data reporting should be added to the
list of reasons for replication failure. These contributory factors are ger-
mane to all of science not only prevention science (Goodman, Fanelli, &
Ioannidis, 2016) and are rooted in philosophical discussion over the process
of falsification and the need for corroboration exemplified by Popper
(1963). Gorman’s claims of replication failure are specific to five indepen-
dently conducted RCTs testing SFP 10–14. Four of these trials were
Kumpfer et al. 7

conducted in Europe and one in the United States, which as he argued did
not show evidence of favorable program outcomes and provide further
evidence of what he termed a decline effect.5 That is, after the initial hoopla,
there is a preponderance of evidence supporting failed replications. The
four European studies with null effects were conducted in Germany (Baldus
et al., 2016; Bröning et al., 2017), Sweden (Skärstrand, Larsson, &
Andréasson, 2008; Skärstrand, Sundell, & Andréasson, 2014), Poland
(e.g., Foxcroft, Callen, Davies, & Okulicz-Kozaryn, 2017; Okulicz-
Kozaryn & Foxcroft, 2012), and Wales (Segrott et al., 2017). The U.S.
study was conducted in the Midwest (Riesch et al., 2012). Gorman then
dug deep into the history of trials supporting the efficacy of SFP 10–14
including a long list of RCTs conducted by the Iowa team. These RCTs
involved the seven-session SFP 10–14 in comparison to the five-session
Preparing for the Drug-Free Years (Redmond, Spoth, Shin, & Lepper,
1999; Spoth & Redmond, 2002; Spoth, Redmond, & Shin, 2001; Spoth,
Redmond, Shin, & Azevedo, 2004), in conjunction with Botvin’s Life Skills
Training program with and without SPF 10–14 as a comparison group
(Spoth, Randall, Trudeau, Shin, & Redmond, 2008; Spoth, Randall, Shin,
& Redmond, 2005; Spoth, Redmond, Trudeau, & Shin, 2002), or a combi-
nation of the three programs (Spoth, Trudeau et al., 2008). All of the studies
included longitudinal follow-up, some extending from late childhood
through adolescence (Spoth et al., 2001; Spoth, Randall, et al., 2008) and
others extending to young adulthood (e.g., Spoth, Trudeau, Guyll, Shin, &
Redmond, 2009; Spoth, Randall, et al., 2008).

Reasons for Replication Failure


Notably, the international studies and the Midwest trial were free of conflict
of interest concerns over developers evaluating their own program (Gor-
man, 2005), provided evidence of high quality implementation, and all
adhered to the published standards of evidence (Flay et al., 2005). Given
these accolades, a pressing question is why the replication failure and what
contributes to what Gorman termed a decline effect? To begin with, one of
the big leaps that programs must make is moving from efficacy trials
conducted in tightly controlled laboratory settings to effectiveness trials,
the latter conducted in community agencies where strict protocol replication
is rendered more difficult because of a variety of competing factors and
circumstances (e.g., Glasgow, Lichtenstein, & Marcus, 2003). These can
include staffing, recruitment (consenting and enrolling), attrition, and finan-
cial problems as well as competing organizational interests including taxing
8 Evaluation & the Health Professions XX(X)

staff work schedules, lack of organizational buy-in, poor implementer effort


or poor training and supervision, lack of stakeholder engagement, or a
program “champion,” all of which can diminish program enthusiasm.
Below, we outline the six most pressing concerns that affect the delivery
and implementation of EBIs. Included in this discussion are strategies that
agencies can utilize to overcome these hurdles when implementing family
EBIs like SFP.

Matching Program Type to the Target Audience and Implementing


With Fidelity
Replication failures can occur because an agency implements an EBI with-
out considering whether the risk levels in their population match those in
the original research trials. This “lack of fit” can increase the chances for
failed results. It is well known that EBIs are primarily effective when they
are delivered to populations similar to those participating in the original
RCT. In many instances, agencies select a program that addresses their
workplace demands. This can result in their choosing the shortest program
given personnel and resource constraints. The end result is the program
selected does not match the required dosage to address relevant family
needs and risks. The seven-session SFP 10–14 is slated to work well in
universal settings with low-risk families. In the case of the Iowa program,
even with the downsizing from 14 to 7 sessions there is sufficient attention
given to risk and protective factors, and enough time is spent rehearsing
newly acquired skills to have an indelible impact on family dynamics. A
different setting, as many of the replication studies encountered, with higher
risk families may require greater dosage obtained through additional ses-
sions. The additional sessions provide more opportunities for learning pro-
gram content as well as practice opportunities to rehearse skills and receive
feedback.
Many have observed that higher risk families participating in family
interventions will experience larger positive changes because they have
more room for improvement. Therefore, qualification of “risk” status plays
a major role in determining the effectiveness of SFP, as it would any
selected or indicated program. In some cases, SFP replications recruited
low-income families assuming this rendered the population at risk (Bröning
et al., 2017). This can be problematic because efforts to recruit from high-
risk or ethnic neighborhoods does not necessarily ensure that families are
deficient in family skills. In other words, by itself, poverty or racial minority
status does not necessarily equate with family risk.6 This is particularly true
Kumpfer et al. 9

when low-income families access psychological resources that buffer risk


(e.g., Burchinal, Follmer, & Bryant, 1996; Markstrom, Marshall, & Tryon,
2000). Furthermore, structural aspects of families such as single parenting
may be “markers’ of risk but not equated with risk in and of itself (Rutter,
2006). In the long run, risk is context-specific and this has to be factored
into the choice and selection of a program. Overall, researchers working
with family-based interventions obtained better results with distressed than
with not distressed, families (e.g., Dishion, Nelson, & Kavanagh, 2003).
The European replications used the seven-session SFP 10–14, a choice
guided partly by the Cochrane meta-analysis findings showing excellent
results with school-based alcohol prevention using the seven-session Iowa
SFP 10–14 (Foxcroft, Ireland, Lister-Sharp, Lowe, & Breen, 2003). How-
ever, despite such success the program may not have suited the population’s
risk level. For instance, Riesch et al. (2012) pointed out that high-
functioning families may have “limited potential gains” (p. 367) from a
brief intervention like SFP 10–14 and, furthermore, the very low levels of
substance use by youth in this age-group may render the content more
abstract than practical among parents who don’t view their children as
deviant or needing extra supervision.

Administering the Right “Dosage” of the EBI


Reduced dosage. Integrity of the treatment, or what is termed dosage, can
heavily influence program outcomes.7 To us, any modifications from the
intended dose will needlessly dilute program effects. There is no formula
for calculating the appropriate dose based on target sample characteristics,
and as a result the program should be implemented in full form to achieve
maximal effects. However, it is fairly common in community agency or
school settings to reduce the dosage of SFP to match local risk levels in
what has become termed “off label” use. However, dosage analyses fre-
quently show that curtailing sessions or eliminating booster sessions
reduces effect sizes (Riesch et al., 2012). Indeed, Riesch and colleagues
opined that effects in their study may have been larger had they chosen the
14-session SFP 6–11 program, which is appropriately targeted to higher risk
families; a position driven partly by the observation that they reported better
program outcomes with a high exposure group (attending ⬎5 sessions of 7).
Program modifications come in various shapes and sizes and can include
selectively implementing lessons, changing exercises, eliminating or, in
some cases, adding new lessons. The Swedish replication eliminated skills
training but added more drug prevention lessons (Skärstrand et al., 2008,
10 Evaluation & the Health Professions XX(X)

2014). Another example is the Hawaii SFP 6–11, where staff added 10 extra
preliminary sessions on Hawaiian cultural values while eliminating regular
SFP skills sessions (Kameoke, 1996). This resulted in high attrition and
poor results until staff restored the original 14-session program creatively
infused with Hawaiian values. A key factor in understanding the role of
dose in program outcomes is to frame effects as the result of an unambig-
uous treatment comparison. In other words, we should not compare SFP as a
treatment to a modified program with fewer sessions. We should compare
SFP administered in its entirety to a no-contact control condition. It is
generally not recommended to compare treatment conditions that vary
dosage levels (based on quantitative cut points).8 SFP should be delivered
in its entirety with no modifications to the dosage of the program as this
maintains curriculum integrity and keeps intact the active ingredients as
they were designed (Small, Cooney, & O’Connor, 2009). This strict pro-
gram adherence will also contribute to an unambiguous interpretation of the
effects that result from intervention exposure.

Properly Training Implementers and Building “Enthusiasm”


Type II errors can also arise from procedural variation in implementation.
This is a major concern when transitioning from efficacy to effectiveness
trials because there is so much greater control exercised in efficacy trials.
This control extends to implementation, which is much easier to regulate in
a controlled trial setting than in real-world conditions using community
agency personnel. Although there are a host of organizational challenges
that can influence implementation, three in particular that are common
issues facing SFP implementation include misconstruing quality for fide-
lity, heterogeneity in implementer experience, and poor quality of imple-
menter training. We briefly discuss each of these considerations below.

Quality is not the same as fidelity. Most SFP replications report a high degree
of fidelity to the model. However, implementing with “fidelity” is not
necessarily implementing with quality and enthusiasm. The Washington,
DC, SFP replication is a good example of this (Gottfredson et al., 2006).
Hired community workers documented fidelity through site visits with
videotapes of live sessions plus fidelity checklists that monitored program
adherence (assessing whether the implementers followed the training man-
uals). However, this process evaluation suggested lackluster implementa-
tion with little enthusiasm or quality, which would diminish favorable
program outcomes. Enthusiastic and competent implementers who are “true
Kumpfer et al. 11

believers” in the effectiveness of SFP provide genuine feedback to partici-


pants, encouraging them to engage in activities, providing examples to
build foundational skills, and ensuring that participants are eager to return
for future sessions. In separate analyses, we correlated SFP outcomes with
facilitator characteristics and found that staff who are very enthusiastic
about the program and committed to helping the families improve obtain
the best outcomes (Kumpfer et al., 2017; Orte, Ballester, Torelló, de Vice-
nte, & Mascaró, 2017).

Implementers not experienced. In the real world, implementer experience can


vary dramatically, but most agency staff are quite competent working with
families that utilize their agency services. When SFP is implemented with
family service agencies, the results match those found in tightly controlled
RCTs. Two replications reinforce this claim including a 5-year study con-
ducted in 75 community agencies in New Jersey and involving all four age
versions of SFP (Kumpfer, Greene, Allen, & Miceli, 2010) and the 10-year
multisite study of SFP 12–16 still underway in Ireland (Kumpfer, Xie, &
O’Driscoll, 2012). The Irish study has obtained consistent positive results
for both high-risk girls and boys using an agency collaborative model with
staffing and family recruitment shared by probation services, alcohol and
drug treatment and prevention, mental health, family services, and the local
police.

Poor quality of implementer training. Staff training is critical to the success of


any family-based intervention, and when suboptimal can invariably under-
mine program fidelity and weaken program outcomes. This is particularly
crucial when working with cultural adaptations or implementing programs
in foreign settings. We always translate all training materials into the lan-
guage of participants and modify the curriculum graphics to appeal to the
target population. When we implement SFP in foreign countries, we use
trainers fluent in the language and familiar with local customs and mores,
educational practices, and family needs. This was the case for an indepen-
dent, large-scale RCT of SFP 6–11 with Burmese refugees in Thailand that
relied heavily on local trainers (Puffer et al., 2017) and was evaluated by an
independent team at Duke University using assessment tools modified in
language and content, with outstanding results. SFP uses a “train-the-
implementers” approach and we used role-playing with parents and teens
to address cultural issues that might crop up during real-time training with
parents and youth. The training focuses on teaching implementers how to
build rapport, confidence, and trust with the families. We also ensure there
12 Evaluation & the Health Professions XX(X)

is optimal organizational “buy-in” to support the training and that agency


leaders are aware of the commitment (monitoring and evaluation) needed to
implement with fidelity.
To summarize, it is possible to achieve high levels of enthusiasm when
training program implementers. This can be achieved through education,
working with the teams to ensure cultural adaptations reflect the community
needs and sensitivities, and also by providing technical assistance and feed-
back not only at the beginning of training but throughout as teams encounter
problems and need direction. Training manuals should explicitly address
commonly encountered problems (i.e., family reticence) but provide a for-
mal basis for “standardization” of the program, so that novelty can be
incorporated without diluting the objectives. Additional strategies to build
enthusiasm include soliciting administrative support, so that workers feel
their back is covered, commitment of resources, and ensuring the program
is perceived as credible before implementation. Overall, enthusiasm is best
recognized as motivation to help the clients but packaged in a way that
allows the strengths of the program to speak volumes on its own.

Maintaining Program Integrity


Lack of fidelity to core elements of the model can also affect outcomes. In
addition to dosage considerations, research shows that too much modifica-
tion can denude a program of its “active ingredients” and weaken effects.
This is precisely what occurred with the Swedish SFP 10–14 RCT, perhaps
contributing to what is termed the decline effect. The high costs associated
with remaking the DVD for Swedish families left sparse funding available
for implementation. As a result, program modifications were made, which
affected dosage, delivery of core competencies, and ultimately disrupted the
program’s deep structure (Resnicow, Soler, Braithwaite, Ahluwalia, &
Butler, 2000). In the Swedish case, SFP was no longer truly a family skills
intervention involving participation of whole families, where parents and
youth enjoyed a meal together and practiced newly acquired skills. To
accommodate their lean financial resources, the Swedish program was
severely curtailed by eliminating the joint parent–youth practice sessions.
Instead, parents met separately at night and school teachers conducted the
youth portion with their whole classrooms of 25–30 youth. The absence of
prescribed group activities coupled with poor classroom management most
likely diminished program effects. Also, regular lessons were dropped and
extra substance use education lessons were added. All of these factors can
Kumpfer et al. 13

attenuate program effects as both fidelity and dosage are compromised


(Segrott et al., 2014).
Indeed, Ferrer-Wreder, Adamson, Kumpfer, and Eichas (2012) and Seg-
rott et al. (2014) questioned the value of the Swedish SFP 10–14 interven-
tion as a direct replication or even a family EBI at all given the substantial
modifications to both content and implementation. By dropping various
crucial elements of the intervention, the Swedish team inadvertently con-
ducted a componential analysis selectively culling key ingredients. The
result suggests that the critical core element of SFP requires attendance
of the whole family (other siblings and caregivers) together and that pro-
gram outcomes are inextricably tied to core features of the program includ-
ing provision of meals together with practice time allotted for rehearsing
new skills, parent–youth weekly practice sessions with facilitator feedback,
and participation in family homework assignments, all of which were
absent in the Swedish replication.

Culturally Tailoring the Program


Cultural adaptation is an essential part of the fidelity discussion. Family-based
programs delivered to different cultural populations require some form of
adaptation (e.g., Castro, Barrera, & Martinez, 2004; Kumpfer, Pinyuchon,
de Melo & Whiteside, 2008). Here again, research shows that cultural
adaptation with family-based programs will increase enrollment and pro-
gram completion (e.g., Kumpfer et al., 2017). We are aware that there is a
fine line between instituting needed cultural adaptation without necessarily
instituting complete program modification. Nonetheless, whenever SFP is
culturally adapted at the surface level (Resnicow et al., 2000) including
enhancements to incorporate the local language, myths, relevant exercises,
games, songs, and rewards, SFP has better recruitment, less attrition, and
better outcomes (Kumpfer, Alvarado, Smith, & Bellamy, 2002). This is also
true of other family EBIs such as multisystemic family therapy, which also
found better recruitment and less attrition when the core intervention stra-
tegies were culturally adapted (Parra-Cardona et al., 2016). In the case of
Familias Unidas, an integrative program specifically constructed for His-
panic immigrant families and targeting youth substance use (Pantin et al.,
2003), specific modules are introduced that address acculturative stress and
parent–child tensions associated with immigration (i.e., reducing barriers
associated with moving to a majority culture).
There is now evidence that culturally adapted SFP versions applied in
non-European cultures have achieved high participation rates and excellent
14 Evaluation & the Health Professions XX(X)

outcomes (Puffer et al., 2017). Added to this, quasi-experimental studies


conducted recently in Spain (Orte et al., 2017), Italy (Oretega, Giannotta,
Latina, & Ciairano, 2012), the Netherlands (Onrust & Bool, 2006), and
Ireland (Kumpfer et al., 2012) produced favorable program outcomes with
the SFP 6–11 and SFP 12–16 programs including large effect sizes. Unfor-
tunately, since these programs do not meet the gold standard of RCTs,
researchers conducting meta-analysis will invariably overlook incorporat-
ing these favorable SFP findings.9
Invariably, there are also examples of programs that fail to institute
cultural adaptations and produce less than stellar outcomes. For instance,
Olds et al. (1997, 2004) successfully conducted three RCTs in the United
States of the Nurse Family Partnership, a program targeting low-income
primiparous mothers to reduce dysfunctional caregiving. However, a U.K.
replication study failed to obtain the same results (Robling et al., 2016),
which the authors attribute to lack of cultural adaptation and poor fit to the
risk levels of the target population. Failure to culturally adapt a program can
also promote resistance on the part of the staff. The Washington, DC, SFP
replication (Gottfredson et al., 2006) provides an example where an aborted
cultural adaptation resulted in poor outcomes. In this case, the implemen-
tation staff were told very early in the process, prior to the first year of
implementation, they could begin preparing a cultural adaption of SFP 6–11
targeting African American families. However, for various reasons,10 the
cultural adaptation was aborted, which lessened staff enthusiasm for the
project and diminished their quality of delivery, with the end result of less
favorable outcomes.
Cultural adaptation runs across several of the themes we have already
discussed including staff training, supervision, process evaluation, and pro-
gram materials (language translation). Each of these factors into the success
of the program but also can weaken attempts at cultural adaptation if not
done correctly using rigorous methods. For example, certain issues relevant
to the core competencies of SFP may not translate directly into another
language. Also, staff may be reluctant to discuss certain sensitive issues
with families given underlying differences in cultural mores. Social con-
texts and family dynamics can also vary between cultures, making it pru-
dent to flesh these issues out in preliminary field work prior to
implementation or through protracted discussion with staff (e.g., Akin
et al., 2016). At the staff level, many cultures will lack experience conduct-
ing process evaluations using formal instruments to gauge fidelity. All of
this needs to be considered before implementation, otherwise it can create
roadblocks and hinder obtaining successful program outcomes. In the long
Kumpfer et al. 15

run, cultural adaptation is not something “stock” that comes off the shelf but
rather involves a lengthy iterative process of program modifications that
involves extensive checks and balances to ensure the program does not
sacrifice fidelity for “fit” (Barrera & Castro, 2006).

Choose the Right Outcome Evaluation Methods


Evaluation practices for family-based programs implemented in community
agency settings are much like an onion; evaluation teams have to learn to
peel away the layers, using different assessment and data collection strate-
gies and measurement tools to discover the different factors that influence
program outcomes. In certain situations, as evidenced by the Washington,
DC, SFP replication, extensive in-person interviews can reveal subtle influ-
ences on program delivery that affect outcomes not evidenced by traditional
statistical analysis. Such efforts can involve the parents, their children, or
implementation staff and may require a mixed-methods approach that
blends qualitative and quantitative assessments strategies to reveal the full
gamut of influences on program outcomes. Included in this process is using
evaluation methods that are developmentally appropriate for the target
audience and culturally appropriate for both the implementation team and
the participants.

Selecting outcome measures not developmentally appropriate. It is likely the


five international SFP 10–14 replications failed to achieve statistically sig-
nificant differences in drug use because of low base rates characteristic of
low-risk 12- to 14-year-olds. For instance, many low-risk children do not
use drugs producing extremely skewed frequency distributions. Although
statistical modeling approaches can be applied to correct for skewness (e.g.,
Olsen & Schafer, 2001), they are not a panacea. In many cases, using
theoretically consonant intermediate measures (i.e., intentions to use) pro-
vides an alternative to model program effects. The 14-week SFP replica-
tions are more successful in achieving larger effect sizes, probably because
they target higher risk 12- to16-year-olds or children in drug involved
families. Also, the low-risk parents attending SFP 10–14 were highly
unlikely to demonstrate the poor parenting or family skills that are the focus
of SFP, making it harder to show improvements. Notwithstanding, low-risk
participants can still benefit a great deal from skills training activities that
are core features of SFP (i.e., parent–child communication, setting bound-
aries, and family organization).
16 Evaluation & the Health Professions XX(X)

Using clinical diagnostic instruments that are not change sensitive. Program
evaluation instruments should be sensitive to change using at least 5-
point Likert-type scales. Most clinical diagnostic instruments like the Child
Behavior Checklist and Strengths and Difficulties Scale only have a 3-point
scale designed as clinical diagnostic instruments and not for evaluation.
They are intended to provide prevalence data but lack the subtleties
required for monitoring true behavior change. It is worth pointing out that
the modified response formats were used in the European SFP 10–14 repli-
cations. Changing response formats can truncate variances, and with
changes in dispersion and first-order moments render findings
nonsignificant.

Use longitudinal repeated measures control group designs. Longitudinal follow-


up is required to discern whether a program has sustained effects over the
long haul and to account for confounding by developmental maturation
(e.g., Collins, 2006). Although SFP can be delivered in the elementary
school years, typically, youth encounter peer pressure to use drugs begin-
ning in middle school and this rapidly increases through high school. Higher
risk youth may encounter these pressures earlier, given their peer group may
express deviant behaviors at an earlier age. Several replications have shown
favorable effects when youth were followed through middle school. For
instance, Bröning et al. (2017) reported 11 of the 18 positive outcomes in
subgroup analyses comparing high- and low-risk youth in the German trial
of SFP 10–14 with 2 years of follow-ups to age 14 years (see also Baldus
et al., 2016). Abstinence outcomes for tobacco, alcohol, and cannabis had
small effect sizes (.10 to .16); however, they needed a larger sample size of
785 versus the 135 that participated to reach statistical significance. Low
power is characteristic of many SFP 10–14 replications leading to erroneous
conclusions the program did not work.

Using regular pretest and posttest instruments. Years of experience assessing


SFP outcomes have shown that regular pretests underestimate family risks
at program entry. This diminishes the amount of positive change and effect
sizes by posttest or subsequent follow-ups. We mainly use a standard pretest
as well as a retrospective pre- and posttest conducted after program gradua-
tion. We found that even parents who had lost their children to foster care
would rate themselves at pretest as wonderful parents with well-behaved
children. Following exposure to self-monitoring assignments and parenting
skills activities, parents are more aware of their deficiencies and rate them-
selves lower. Brook, Akin, Lloyd, Bhattarai, and McDonald (2016)
Kumpfer et al. 17

provided evidence that the retrospective pretest is more accurate and


matched the implementers’ ratings of the families. The retrospective pret-
est–posttest design can provide more “veridical” assessments of self-
behavior, owing to giving participants realistic anchors and avoiding
response shift bias (Chang & Little, 2018).

Provide an Accurate and Complete Outcome Evaluation Report


The value of statistical significance versus clinical significance or effect size to
determine effectiveness. Tradition suggests that the benchmark for a valid
intervention effect is statistical significance set by a p value below .05
rather than clinical significance measured by effect size or how much
clients changed. Replication failures often arise because of low power or
small sample sizes that prevent a statistical comparison from achieving
statistical significance (Maxwell et al., 2015). Relatively, large sample sizes
observed in the original RCTs conducted by Spoth and colleagues were able
to produce statistical significance with small effect sizes. However, these
results are not replicable with smaller studies that may involve a handful of
agencies that bundle their intervention efforts together. Hence, Tryon
(2016) suggests that, as a general rule, we should avoid relying on single
studies and especially avoid comparisons to generously funded university-
based RCTs with large sample sizes.
A central factor when considering EBIs should consider effect sizes,
which should receive equal if not greater attention than statistical signifi-
cance.11 This consideration should extend to outcomes as well as putative
mediators. Furthermore, a significance test can obtain p values below the
nominal .05 even if effect sizes are small if the sample is sufficiently large.
To avoid criticism, evaluators should publish effects sizes bounded by
confidence intervals for the full gamut of outcomes, which is more useful
to clinicians determining which interventions work best and under what
conditions (e.g., Simmons, Nelson, & Simonsohn, 2011). This is the pre-
ferred strategy that Kumpfer, Magalhães, Whiteside, and Xie (2016) fol-
lowed when they published all 18 parent, family and child outcomes, and
their effect sizes (which are medium to large size) for each 14- or 10-week
SFP study.
Strategically, evaluation analyses should include a careful examination
whether the program has sizable effects on parenting skills, family relations,
and child or youth outcomes other than substance abuse. There is consid-
erable evidence showing that SFP has favorable program effects on depres-
sion, overt and covert aggression, delinquency, and school performance
18 Evaluation & the Health Professions XX(X)

(Kumpfer et al., 2017). These developmental outcomes are just as important


as substance use because research shows they have a direct effect on sub-
stance abuse. This latter view is consistent with problem behavior theory
(Jessor & Jessor, 1977), which posits there is a constellation of negative
developmental outcomes sharing common etiological pathways. It is also a
mainstay in developmental psychopathology, which uses the concept of
equifinality to support how multiple pathways can lead to a single outcome
and, in some cases, a single pathway, referenced as multifinality, can lead to
divergent outcomes (Cicchetti & Rogosch, 1996). In this case, correcting
family dynamics as a singular focus can produce multiple favorable
outcomes.

Why Real World Replications Can Fail to Replicate Original RCT


Results
There are a number of other reasons for replication failure that still need to
be addressed. Contamination of the no-treatment control group is one of
several threats to internal validity and can happen for a variety of reasons.
Contamination can occur because trainers within a single family service
agency encounter and work with both intervention and control cases on a
daily basis. In the Washington, DC, SFP 6–11 replication, the implemen-
tation team sometimes applied SFP or other clinical techniques to assist
minimal contact control families leading to improvements in control fam-
ilies. This causes diffusion of treatment and violates the stable unit treat-
ment value assumption required to maintain causal inferences (Rubin,
2005). Some solutions to prevent contamination are increase the number
of trainers, which is often cost prohibitive; increase the number of family
service agencies and clinics to avoid diffusion of treatment; or have min-
imal face-to-face contact with the control group until time to take the
posttest.

Including intention-to-treat families in the analyses can be misleading. Several


SFP replication studies have relied on intention-to-treat analyses. In this
scenario, families are included in the data analysis based on their original
experimental assignment irrespective of their continued participation
throughout the duration of the study.12 This methodology is traditionally
used with clinical trials and public health initiatives to capture information
from missing subjects irrespective of their exposure levels (e.g., Heritier,
Gebski, & Keech, 2003). Unfortunately, this approach to data analysis will
include families (parents and youth) regardless of whether they attended
Kumpfer et al. 19

one or two sessions or even none at all (e.g., Dishion, Kavanagh, Schneiger,
Nelson, & Kaufman, 2002). Since dosage is apparently a major factor in
program success, this reduces the outcome effect sizes of those that actually
attended most or all sessions. Program evaluators need to consider the
influence of missing sessions and find ways to differentiate this phenom-
enon from lack of exposure that can arise from poor fidelity (the program is
delivered but poorly). Then, they need to figure ways to properly evaluate
the program for participants that were present and received a majority of the
treatment (i.e., high fidelity analyses). There is now more work ensuing that
uses inverse probability weighting and propensity scoring methods to adjust
postrandomization for session attendance or dropout status and that bears on
the issue of exposure (e.g., Little & Yau, 1998; Tein et al., 2018). Following
these, few recommendations will inform the public whether the program
achieves its objectives when delivered efficiently and with fidelity.

Inaccurate Outcome Reporting


Selective data reporting. Utilization of flexible data analysis can also contrib-
ute to Type II errors. By this, Simmons, Nelson, and Simonsohn (2011)
mean that dicing up analyses to accommodate elimination of certain sub-
jects, effectively examining minimal dosage requirements, conducting sub-
group analyses using high fidelity participants, or creative manipulation of
outcomes (i.e., dichotomization; MacCallum, Zhang, Preacher, & Rucker,
2002), all of which can inadvertently bias statistical findings and increase
the incidence of false positive rates. Simmons et al. suggest that there is no
malicious intent here but “ambiguity” that comes along with making deci-
sions how to approach data analysis. Their simulations show convincingly
that even increasing the sample size by adding 10 observations or control-
ling for a covariate and its interaction can appreciably increase the false-
positive rate. All of this leads to the conclusion that there is a need for
greater transparency in data decision making. This arises because of the
“researcher degrees of freedom” (p. 1359) or stated differently, many pro-
gram developers are heavily invested in finding out whether their interven-
tion produces favorable outcomes (i.e., lowered drug prevalence rates) no
matter the framework for analyzing the data. In other words, most research-
ers believe that no matter the approach, or the cost, it is worth finding out if
their program works in some way or another.
Consistent with these considerations, we recommend avoiding selective
analyses unless they are consistent with theory, hypothesis driven, and
represent promising avenues of inquiry. We also hold that there are analysis
20 Evaluation & the Health Professions XX(X)

strategies that require explicit rationales. For instance, many researchers


examine gender subgroup analysis without providing explanations for why
a program should work differently for boys and girls. Programmatically
speaking, this requires some attempt at using gender socialization to argue
unique pathways or differential program outcomes. Likewise, race/ethnic
group is often used to calibrate program effects without providing explana-
tion for the observed differences. Why would Black or Hispanic youth react
differently to the program content or implementation? This requires more
careful thinking that has strong theoretical roots and considers race-specific
contextual factors. This line of reasoning extends to using high versus low
fidelity groups in analyses to determine moderation of program effects. It
should be clear that parents/children receiving high dosages may fare better,
but there is no hard and fast rule on what constitutes a sufficient dose. More
research is needed to determine whether there are critical cut points that
qualify necessary and sufficient dosages. Likewise, tabling all of the des-
ignated outcomes for both parents and children presents the best case sce-
nario rather than selectively reporting outcomes only achieving
significance. In addition, flexibility pertains to conducting multiple post
hoc tests and using one- versus two-tailed tests. The problem of multiplicity
in analyses is rampant in science and has come under criticism before (e.g.,
Goodman et al., 2016). To avoid p-hacking, the norm should be a well-
designed set of analyses to address the stated hypotheses with appropriate
one-tailed tests, since we don’t expect the program to have an iatrogenic
effect and increase drug use (e.g., Head, Holman, Lanfear, Kahn, & Jen-
nions, 2015).

Failure to report all SFP outcomes. Claims of replication failure are tied to the
assertion that SFP 10–14 replications were unable to show reductions in
rates of substance use. As we already stated, this strategy emphasizes a
focus on substance use outcomes, which are unlikely to show marked
change in low-risk students reporting nominal amounts of drug use. We
have also stated in numerous places that reductions in substance use is not
the sole goal of SFP, which also focuses on mental health and behavioral
disorders, child maltreatment, school performance, and other related devel-
opmental problems that interfere with normal functioning (Kumpfer et al.,
2016). The action theory for SFP posits the program works generatively
through putative mediators (i.e., parenting, family, and youth skills) that are
formative in protecting youth against a wide range of negative develop-
mental outcomes. In keeping with this view, it pays to examine short-term
measurable goals on putative mediators, many of which are precursors to
Kumpfer et al. 21

youth substance use. This was the case in the five cited replications (Brön-
ing et al., 2017) and evidenced in other family EBIs (e.g., Van Ryzin,
Kumpfer, Fosco, & Greenberg, 2016). This emphasis is partly guided by
a national mandate and public health demands (U.S. Department of Health
and Human Services, 2016).
Many of the anticipated changed in mediators also contribute to positive
developmental outcomes requiring that we also inspect changes in these
behaviors (e.g., school performance) to note the different directions that
improved family functioning can take. This latter position is consistent with
developmental cascade models that are today’s norm in both etiology (e.g.,
Eiden et al., 2016) and prevention (Patterson, Forgatch, & DeGarmo, 2010).
There are several prime examples of the cascading effect of SFP on impor-
tant aspects of positive youth adaptation. For example, the Safe African
American Families program, a modified version of SFP 10–14 (Kogan
et al., 2016) found 50% reductions in diagnosed depression and anxiety,
substance abuse, criminality, and HIV status at 10-year follow-up. These
favorable outcomes were observed in the 30% of the participating youth
who had genetic risks for various disorders determined by a saliva test
(Brody et al., 2012). Moreover, a separate independent evaluation of SFP
3–5 and 6–11 as part of a multistate trial showed favorable program out-
comes with reduced child maltreatment and days remaining in foster care
cut by half (Brook et al., 2012). A cost recovery study found millions of
dollars were saved with SFP (Johnson-Motoyama, Brook, Yan, & McDo-
nald, 2013). Certainly, we should not dismiss or discount these promising
findings. Additionally, there are studies that augmented SFP with additional
mindfulness training and reported favorable outcomes (Coatsworth et al.,
2014). All in all, and given the heavy modifications to the core SFP com-
petencies, these studies may not represent “direct” replications; however,
they do provide additional evidence of the basic effectiveness of the unique
SFP family skills training model.

How Can We Know What Really Works?


One solution is to use small clinical RCTs. Since large-scale RCTs are very
expensive, another solution would be repeated small scale RCTs conducted
in clinical settings with real clients. This approach was used for Triple P
(Sanders, Baker, & Turner, 2012), which is listed on several EBI websites.
The authors used a short-term waiting list experimental design. Dynamic
wait list, rolling recruitment or a stepped wedge design are approaches that
more family EBIs should consider. This is the approach we took with SFP
22 Evaluation & the Health Professions XX(X)

7–17 using agencies in a three-state study including NY, NC, and UT. Other
possible solutions to increasing knowledge of what works in reality is to
broaden the definition of effectiveness. Reviewers or raters preparing list-
ings on websites of EBIs need to consider more than just medical model
RCTs as proof of effectiveness. What should matter more are not Phase III
clinical efficacy trials, but multiple Phase IV effectiveness trials in the field
to determine whether the EBI works with diverse clients in diverse settings.
Thereafter, the next phase involves Phase V dissemination trials when
going to scale with large numbers of clients. As a general rule, we should
all be more inclined to consider the total weight of the evidence for an
intervention obtained from multiple studies (Goodman et al., 2016), and
hopefully ones that are conducted by independent research teams.

Should Replication Failure Worry Us?


Should we be worried by the reported failures? The answer is both “yes”
and “no.” We should certainly attempt to glean more information regarding
why failure occurs overall, and so that other agencies don’t make the same
mistakes. While the five independent replications failed to completely repli-
cate the SFP 10–14 program effects on drug use, SFP has a long history of
positive results. For the reasons outlined in this article, we believe these
failures are symptomatic of poor implementation and do not undermine the
program’s integrity or its capabilities. As Strobe and Strack (2014) pointed
out, “Even multiple failures to replicate an established program finding
would not result in a rejection of the original hypothesis, if there are also
multiple studies that supported that hypothesis” (p. 64). Since there are
multiple studies supporting SFP 10–14 effectiveness, there is sufficient
evidence supporting favorable SFP outcomes obtained from RCTs with the
14-session SFP (Kumpfer et al., 2002; Puffer et al., 2017), evaluations
relying on propensity matching techniques (Brook et al., 2016) and numer-
ous quasi-experimental, large sample field studies (Kumpfer et al., 2010,
2012).
Reichardt (2011) points out that in terms of evaluation science, there is a
tremendous difference between asking “what is the effect of a given cause?”
as opposed to “what is the cause of a given effect.” Program evaluation
attends only to the first question, whereas the second question, while also
quite compelling, is reserved for asking what happened during implemen-
tation that may have affected the outcomes. This crucial distinction is often
not made when evaluating programs but is necessary to find the fine line
that divides why some programs work in efficacy trials and then don’t
Kumpfer et al. 23

replicate in effectiveness trials. In this article, we have discussed ways to


avoid replication failure, protect against the decline effect, and eliminate
Type II errors that result in negative findings with a program that has a
proven track record and is regarded as “evidence based.” In essence, we
bridge the chasm between Reichardt’s causal statements showing that
greater attention should be paid to factors mitigating program efficacy and
creating a closer alliance between implementation and prevention science
(e.g., Wandersman et al., 2008). In this regard, family-based programs
should not be selected based solely on cost or length, as if shorter programs
are going to be equally effective as lengthier programs. Dosage and content
of a program has to match the risk profiles of the clients. This may go a long
way toward avoiding the problems we addressed here, regarding the effec-
tiveness of programs with low-risk populations. The one-size-fits-all
approach may not work with family-based interventions, which may require
that program content is tailored or carefully customized for different
populations.
Family-based programs administered in real-world settings should be
implemented with adequate support services; ensuring organizational
buy-in; gathering stakeholder support; using well-trained, experienced, and
committed implementers who are considered program “champions,” imple-
mented with fidelity (not cutting out sessions or adding new untested ones),
maintaining proper dosage fitting the target populations’ needs, and cultu-
rally adapting the program using community-participatory strategies that
enhances buy-in. Frequently, financial and market factors often dictate
selection of EBIs without concern for length, appropriateness, or the fit
of a program to the risk levels of the population. The truth is that the
program contents, structure, and delivery mechanisms (including dosage)
has to match the risk level of the clients. Hence, applying EBIs developed
and tested for universal low-risk populations should not be considered
effective for high-risk populations until tested with that population. Pro-
gram effects that vary based on subgroup status (higher vs. lower risk) are
considered compensatory for higher risk groups and leveraging for lower
risk groups. Regardless of distinction, evidence of moderation of effects by
risk status lessens the ability of a program to be regarded as truly universal
(Spoth, Shin, Guyll, Redmond & Azevedo, 2006).
When deliberating these choices we need also consider not only the final
outcome measures but also mediators or precursor variables that are targets
of the intervention. Examples of mediators should include improvements in
parenting skills and family relations and examples of alternative
“precursors” could include child or youth outcomes such as depression,
24 Evaluation & the Health Professions XX(X)

overt and covert aggression, as these are proven antecedents to youth sub-
stance abuse and delinquency (Kumpfer et al., 2016). Overall, there are a
myriad of factors that impinge on the success of a program when imple-
mented in real-world settings. Only when all of these factors have been
considered can we really know the truth about program effectiveness.

Notes
1. These overlap somewhat with the 11 principles of program effectiveness out-
lined by Small, Cooney, and O’Conner (2009) but depart somewhat based on
our experience of implementing family-based and evidence-based
interventions.
2. Actual program length is 2.5 hr per session with a coordinated meal for the first
half hour. The sessions are led by gender-balanced and ethnically matched
trained implementers.
3. The trial was designed as a substance abuse prevention strategy for parents with
opiate, narcotic, and polydrug use dependencies. The parents readily recognized
they were dysfunctional, spending less time with their child, frequently using
negative punishment, and lacking positive parenting and child management
skills. The program focused primarily on parenting skills training but includes
some drug education taught using didactic methods. By all accounts, this ver-
sion of the program was “selective”; however, it has since been recast as a
universal prevention program, targeting lower risk families with fewer personal,
and child management problems.
4. Dr. Kumpfer was the Co-PI on the ISU grant and PI on the original 1982 NIDA
grant (R01 #DA02758-01/5), “Prevention Services to Children of Substance
Abusing Parents.” She worked collaboratively with researchers at Iowa State
University to design SFP 10–14; however, she had no direct involvement in
reporting outcomes of the Iowa SFP 10–14, which is copyrighted and marketed
through Iowa State University.
5. This term was originally used by Reeves and Rhine (1943) as part of their
parapsychological research conducted at Duke University.
6. Hill’s (1972) classic examination of resilience among inner-city Black families
makes this point.
7. In some circles, this is also called adherence and fidelity. Here, we mean only to
discuss the integrity of the treatment at a more global level in terms of the
amount of exposure the participant receives (i.e., contact hours or sessions and
their respective intensity). Fidelity and adherence go beyond this definition to
include the way the program is taught, how closely the implementation staff
adhere to the training manual, and programmatic modifications made on the
spur of the moment (delivery of program content on a session-by-session basis).
Kumpfer et al. 25

8. This would be consistent with a regression-discontinuity design using a pre-


determined cutoff value. Experimental comparisons would then contrast differ-
ent “dosage levels” to determine effects.
9. Interestingly, Gorman selectively excluded several randomized control trial that
emphasized cultural adaptations or studies of implementation. He also excluded
studies without control groups, albeit we learn a great deal from implementation
studies because the helps to paint a more vivid picture of real-world concerns
that can interfere with successful execution. The end result is that we know a
great deal about efficacy but little about effectiveness.
10. A prime reason for abandoning the cultural adaptation was the extra experi-
mental condition would reduce power in a design that already had four condi-
tions. Other factors diminishing program effects may have included
contamination of the minimal contact control condition, relatively high staff
turnover, poor staff training, and high community disorganization, to name a
few, all of which adversely affected program outcomes.
11. There is considerable debate in the psychological sciences regarding the value
of null hypothesis testing and the value of effect sizes as opposed to significance
testing (e.g., Nickerson, 2000).
12. One factor that contributes to this situation is noncompliance that arises from
participants’ crossing over between treatments regardless of whether the staff
caused this to occur or other reasons like resentful demoralization or compen-
satory rivalry. Regardless of the origin of noncompliance, motivational factors
that differentiate participants represent “selection differences” postrandomiza-
tion that need to be controlled statistically.

Declaration of Conflicting Interests


The author(s) declared no potential conflicts of interest with respect to the research,
authorship, and/or publication of this article.

Funding
The author(s) received no financial support for the research, authorship, and/or
publication of this article.

ORCID iD
Lawrence M. Scheier http://orcid.org/0000-0003-2254-0123

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