Strategies To Avoid Replication Failure
Strategies To Avoid Replication Failure
1-34
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Replication Failure DOI: 10.1177/0163278718772886
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With Evidence-
Based Prevention
Interventions: Case
Examples From
the Strengthening
Families Program
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
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.
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/).
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).
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.
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
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).
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.
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.
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.
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.
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
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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