Geretsegger et al.

BMC Pediatrics 2012, 12:2

http://www.biomedcentral.com/1471-2431/12/2

STUDY PROTOCOL Open Access

Randomised controlled trial of improvisational

music therapy’s effectiveness for children with
autism spectrum disorders (TIME-A): study
protocol
Monika Geretsegger1,2, Ulla Holck1 and Christian Gold3*

Abstract
Background: Previous research has suggested that music therapy may facilitate skills in areas typically affected by
autism spectrum disorders such as social interaction and communication. However, generalisability of previous
findings has been restricted, as studies were limited in either methodological accuracy or the clinical relevance of
their approach. The aim of this study is to determine effects of improvisational music therapy on social
communication skills of children with autism spectrum disorders. An additional aim of the study is to examine if
variation in dose of treatment (i.e., number of music therapy sessions per week) affects outcome of therapy, and to
determine cost-effectiveness.
Methods/Design: Children aged between 4;0 and 6;11 years who are diagnosed with autism spectrum disorder
will be randomly assigned to one of three conditions. Parents of all participants will receive three sessions of
parent counselling (at 0, 2, and 5 months). In addition, children randomised to the two intervention groups will be
offered individual, improvisational music therapy over a period of five months, either one session (low-intensity) or
three sessions (high-intensity) per week. Generalised effects of music therapy will be measured using standardised
scales completed by blinded assessors (Autism Diagnostic Observation Schedule, ADOS) and parents (Social
Responsiveness Scale, SRS) before and 2, 5, and 12 months after randomisation. Cost effectiveness will be
calculated as man years. A group sequential design with first interim look at N = 235 will ensure both power and
efficiency.
Discussion: Responding to the need for more rigorously designed trials examining the effectiveness of music
therapy in autism spectrum disorders, this pragmatic trial sets out to generate findings that will be well
generalisable to clinical practice. Addressing the issue of dose variation, this study’s results will also provide
information on the relevance of session frequency for therapy outcome.
Trial Registration: Current Controlled Trials ISRCTN78923965.

Background range of different approaches. Yet, for most of the var-

Impairments or delayed development in skills concern- ious intervention methods available and reported within
ing social interaction and communication are at the ASD that are designed to improve communication and
core of autism spectrum disorders (ASD) [1]. The social interaction, only insufficient evidence of effective-
attempts to help children with ASD develop meaningful ness exists [2]. Some favourable results can be found for
language and social communication skills cover a wide approaches such as early behavioural interventions [3,4]
and augmentative communication [5]. However, if meth-
odologically rigorous standards are applied, statistically
* Correspondence: [email protected] significant improvements in communication and speech
3
Grieg Academy Music Therapy Research Centre (GAMUT), Uni Health, Uni
Research, Bergen, Norway could hitherto only be ascertained in a parent-mediated
Full list of author information is available at the end of the article

© 2012 Geretsegger et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly cited.
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communication-focused intervention [6], parent- music therapy may facilitate skills fundamental to social
mediated behavioural interventions [2], and music ther- interaction in children with autism and proves to be
apy [2,7]. Similarly, in a review of “novel and emerging effective in improving lower levels of initiating joint
treatments” for ASD [8] including several nutritional attention and responding to joint attention bids. Despite
supplements, diets, medications, and nonbiological treat- this trial’s significant results, some methodological con-
ments, it was found that the only treatment options that straints such as its small sample size (N = 10) and large
reached the highest ranking in an evidence-based grad- number of outcome measures limited the generalisability
ing system were melatonin, acetylcholinesterase inhibi- of its findings. Recent RCTs with slightly larger sample
tors, naltrexone, and music therapy. Considering that sizes of N = 23 (unpublished report, Thompson, McFer-
pharmacological treatments typically target symptoms ran, and Wigram, 2011) and N = 24 [16], respectively,
such as hyperactivity, agitation, or sleep disorders rather also investigated effects of improvisational, child-centred
than core symptoms of ASD, and may have adverse music therapy approaches on social communication skills
effects [2,8], music therapy can be viewed as a promis- of young children with ASD, but were still seriously lim-
ing, but not yet sufficiently evidenced treatment for ited in sample size and test power. A large pragmatic
improving social interaction and communication skills RCT is needed to decide if improvisational music therapy
within ASD. Due to various methodological quality lim- improves core symptoms of ASD in a generalised setting.
itations of previous studies [2], further high quality ran-
domised controlled trials (RCTs) on common Objectives
interventions for ASD have been found to be urgently The objectives of this study are as follows:
needed. 1.) To determine whether music therapy is superior to
Music therapy has a long tradition within ASD [9,10], standard care in improving social communicative skills
and there are many clinical reports, case studies, and in children with ASD as assessed by independent clini-
single group studies (e.g. [11-13]; for an overview, see cians at the end of the treatment period.
[14]) suggesting that music therapy may enhance skills 2.) To determine whether music therapy is superior to
of social communication such as initiating and respond- standard care in improving social responsiveness in chil-
ing to communicative acts. In recent years, increased dren with ASD as assessed by parents/guardians at the
efforts have been made to conduct more rigorous stu- end of the treatment period.
dies in this area. A Cochrane review combining the find- 3.) To determine whether the response varies with
ings of three small controlled studies of music therapy variation of treatment intensity.
in children with ASD [7] concluded that this type of 4.) To determine how the development of social com-
intervention may have positive effects on the communi- municative skills proceeds until follow-up twelve
cative skills of children with ASD, but also noted limited months after the start of treatment.
applicability of the studies’ results to clinical practice It is predicted that children’s social communicative
due to very short duration of treatment conditions and ability will increase over time, that social communicative
low flexibility in music therapy techniques applied. skills may be better in music therapy conditions than in
Following this review, some RCTs were conducted the standard care condition, and that more frequent
that strived for improved clinical relevance by applying music therapy may intensify the improvement in the
treatment durations of several months as well as impro- skills assessed. Assessing participants’ social communica-
visational, flexible, child-centred methods of music ther- tive skills seven months after ending of treatment (12
apy provided by trained therapists [15-17]. months after randomisation) will yield important infor-
Improvisational music therapy for children with ASD mation on whether any effects in the skills investigated
may generally be described as a child-centred approach will be sustained.
making use of the potential for social engagement and
expression of emotions occurring through improvisa- Methods/Design
tional music making. Instead of practising targeted skills Participants
in an abstract manner, improvisational music therapy has The study will include children referred from participat-
been noted for its potential to provide a meaningful fra- ing institutions (hospital departments, development cen-
mework that, similar to early mother-infant interaction, tres, parents’ support groups) who comply with the
encompasses relevant features of social communication following criteria:
such as being embedded in a shared history of interac- Inclusion criteria
tion, having a common focus of attention, turn-taking, (a) Aged 4;0 to 6;11: At their respective time of rando-
and musical and emotional attunement [15-18]. In the misation, the participants’ age ranges between 4;0 and
first of these newer RCTs on child-centred music therapy 6;11. Given the nature of basic social communication
methods [15], it was suggested that improvisational skills that are targeted in this study as occurring early in
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development, inclusion of young children is considered [23]. In cases where the application of the K-ABC is not
necessary; as it will be desirable for children to be able possible due to the respective child’s limitations in com-
to attend therapy sessions without their parents, the plying with the requirements of the testing situation,
lower age boundary was chosen based on the experience children’s level of cognitive functioning will be estimated
that children will usually be able to attend therapy in a by the assessor to fall into one of three categories (no
one-to-one setting at that age; a further reason for set- mental retardation vs. mild mental retardation vs. mod-
ting the lower boundary at 4 years is that one of the erate to profound mental retardation according to ICD-
scales measuring outcome (SRS, see below) is standar- 10 criteria) using clinical judgment. To establish the
dised for children from age 4. The upper age boundary baseline of the secondary outcome measure, parents/
was chosen in order to limit the sample to a group shar- guardians will be asked to complete the Social Respon-
ing similar everyday life conditions in preschool settings siveness Scale (SRS) [24]. In addition, standard demo-
and/or around the time of transfer to school. graphic parameters (gender, age, first language, family
(b) Diagnosis of autism spectrum disorder: Participants size, parents’ educational background), comorbidities,
must have a diagnosis of an autism spectrum disorder and information on concomitant treatment will be
as assessed by a child psychiatrist or clinical psycholo- recorded.
gist according to ICD-10 criteria before their respective
baseline assessment. Participants’ diagnosis of ASD Interventions
needs to be reconfirmed in the baseline assessment with Participants will be randomly assigned to one of the fol-
children fulfilling diagnostic criteria for ASD on the lowing three conditions:
Autism Diagnostic Observation Schedule (ADOS) [19] (1) High-intensity music therapy: Improvisational
and on two of three domains of the Autism Diagnostic music therapy sessions in an individual setting thrice
Interview-Revised (ADI-R) [20]. weekly for five months (i.e., a total of up to 60 sessions,
Exclusion criteria depending on possible omission of single sessions due
(a) Serious sensory disorder: Children participating in the to sickness or holidays), and three sessions of parent
study must not be affected by serious sensory disorders counselling as a “standard care condition” (one session
such as blindness or deafness as this would alter the at baseline, one after two months, and a third one after
aim, course, and implementation of therapy. five months).
(b) Previous experience of music therapy: Children hav- (2) Low-intensity music therapy: Improvisational music
ing had music therapy sessions prior to study enrolment therapy sessions in an individual setting once a week for
will not be included as this would be likely to have a five months (i.e., a total of up to 20 sessions), and three
strong influence on the course of therapy. sessions of parent counselling (at baseline, two months,
Non-verbal children as well as children with language and five months).
skills may be included. Parents/guardians must give (3) Standard care: Three sessions of parent counsel-
informed consent for their children to be involved in ling (at baseline, after two months, and after five
the study. Participants must be able to attend up to months).
three weekly music therapy sessions. In cases where Concomitant treatment
transportation to and from locations where the therapy Any concomitant treatment or therapeutic interventions
sessions take place might be difficult to provide by par- that participating children might receive outside the trial
ents/guardians, travelling allowances may be made avail- will be recorded during assessment sessions before ran-
able to avoid bias or drop-out due to any family’s domisation and after 2, 5, and 12 months, specifying the
financial restrictions. kind and amount or frequency of intervention.
We consider a treatment duration of five months to
Baseline assessment be sufficient for detectable developments in children’s
To support the diagnosis of autism, and to establish a social communication skills. Some of the earlier RCTs
baseline of the respective outcome measure, the Autism on music therapy in autism [15-17] were able to identify
Diagnostic Observation Schedule (ADOS) [19] will be effects with shorter or similar duration; see also a meta-
administered to potential participants. Additionally, the analysis of the dose-effect relationship in music therapy
Autism Diagnostic Interview-Revised (ADI-R) [20] will [25]. Additionally, we believe this time frame not to be
be administered to parents/guardians to acquire data overly long for being able to sustain parents’/guardians’
not only on the behaviour displayed during baseline motivation to participate in the study.
assessment, but also on the history of development of Description of music therapy
each child, and to avoid loss of specificity [21,22]. The The duration of music therapy sessions will be 30 min-
children’s level of cognitive ability will be assessed using utes. Therapists conducting the music therapy sessions
the Kaufman Assessment Battery for Children (K-ABC) will be trained music therapists (master’s level or
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equivalent) with clinical experience of working with treatment guide according to the child’s spontaneous
children with ASD. social behaviours will also ensure that the intervention
The music therapy approach applied in this study is will be shaped in a way that is tailored to the individual
based on the ideas and principles of improvisational strengths and needs of each child, thus addressing the
music therapy [26,27], findings from previous music great variability of developmental profiles present in
therapy research [13,15-17,28], and developmental psy- children on the autism spectrum. The treatment guide
chology [29]. The music played or sung by the therapist will be described in a separate paper.
is generally attuned to the child’s (musical or other) Assessment of treatment fidelity
behaviour and expression and includes various improvi- To determine if the treatment is conducted as intended,
sational techniques to engage the child and establish fidelity check measures will be applied as follows: after
contact with the child. To this end, “musical” features of every session, the therapist/counsellor will document
the child’s expression (pulse, rhythmic, dynamic or significant events, notable child/parent behaviours, and
melodic patterns, timbre etc.) may be mirrored, rein- interventions applied. In addition to these self-reports,
forced, or complemented, thus allowing for moments of all therapy and parent counselling sessions will be video-
synchronisation between child and therapist and giving taped to allow for assessment by independent raters
the child’s expressions a pragmatic meaning within the [33]. As in a previous RCT in music therapy [34], adher-
context. To allow elicitation of specific social communi- ence to the method and competence in its application
cative behaviours, the therapist may also gently provoke will also be monitored and sustained through clinical
the child e.g. by violating expectations or jointly devel- supervision of music therapists/counsellors, utilising the
oped patterns. While engaging in joint musical activities therapists’ clinical notes and video-recordings of sessions
within a shared history of interaction, the child is where necessary.
offered opportunities to develop and enhance skills such
as affect sharing, joint attention, imitation, reciprocity, Study design
and turn-taking, all of which are associated with later The study will be a pragmatic international multicentre
development in language and social competency [30,31]. single-blind (assessor-blinded) randomised controlled
Description of parent counselling trial with three parallel arms. After inclusion in the
Parent counselling sessions will be approximately 60 study and baseline assessment, participants will be
minutes and will be conducted by a music therapist assigned to one of the music therapy conditions or the
and/or clinical psychologist experienced in the field of standard care condition on an individual basis according
ASD. Counselling sessions will comprise supporting to a computer generated randomisation list. The alloca-
conversations with a focus on current concerns, pro- tion ratio of intended numbers of participants in the
blems, and difficulties arising from the child’s diagnosis, comparison groups will be 1:1:2 so that the number of
behaviour, and development over time as well as provid- children receiving music therapy will be similar to the
ing information about ASD, child development, and number of participants in the standard care condition.
social communication relevant to the families’ everyday To this end, randomisation will be made in blocks with
life situations. random sequences of block sizes of 4 or 8 respectively
Treatment guide for music therapy and parent counselling (a separate list for each site) to avoid possible guessing
Music therapy and parent counselling sessions will both of some allocations. Before random assignment is per-
be provided in accordance with a treatment guide formed, it has to be confirmed by the investigator
devised for this study in order to specify the treatment recruiting participants that the eligibility criteria have
procedures and to allow for training of staff and replica- been met and participants are formally enrolled. Once
tion of treatment. Within this guide, the setting, general recruitment and data collection at baseline are complete
goals, and basic principles of the intervention as well as and informed consent to participate in the study by the
exemplifications will be outlined. The guidelines are to parents/guardians has been obtained, the respective ran-
be administered flexibly according to the requirements domisation code will be revealed to the investigator by
of the respective situation and needs of the client or an administrative person at the central randomisation
parent within the therapy process or counselling session office who will have no contact to participants. An over-
and can only be applied in combination with and relying view of the study design is shown in Figure 1.
on the clinical expertise of the therapist or counsellor.
While the treatment guide will help to ensure the Power calculation and sample size
trial’s validity and replicability, it is also important to Estimate of effect size
retain flexibility and openness to emerging procedures A Cochrane review on music therapy for ASD found
within music therapy in clinical practice [32]. Keeping effect sizes (standardised mean differences) of d = 0.50
enough “space” for flexible adaptation within the and 0.36 for gestural and verbal communicative skills,
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all children at participating institutions

- aged 4;0 – 6;11
- diagnosed with autism spectrum disorder
 disorder
- no serious sensory
- no previous experience of music therapy


    
first contact with investigator:
   reported, but
no
agreement to participate in the study? not followed-up
(written informed  consent)

yes


pretest/baseline assessment on ASD
(ADOS, ADI-R) & cognitive ability
(K-ABC) by blind  assessors; parent report
(SRS); obtaining information on
concomitant treatment



randomisation – continued until stopping boundary is reached

High-intensity music therapy:  music therapy:

Low-intensity Standard care:
improvisational music therapy, improvisational music therapy, parent counselling (3 sessions),
three sessions per week (up to 60 one session per week (up to 20 no music therapy
sessions), sessions),
parent counselling (3 sessions) parent counselling
 (3 sessions)
continued for 5 months continued for 5 months continued for 5 months

assessment of treatment fidelity: therapist/counsellor
 self-rating, videotaping of all sessions, independent rating
of randomly selected sessions, supervision of therapists/counsellors

2 months (intermediate) & 5 months (end of intervention) after randomisation:

assessment using ADOS (blind assessors) & SRS (parents); obtaining information on concomitant treatment

12 months after randomisation (follow-up):

assessment using ADOS (blind assessors) & SRS (parents); obtaining information on concomitant treatment

Figure 1 Flow chart of the study design. Abbreviations: ASD - autism spectrum disorders; ADOS - Autism Diagnostic Observation Schedule;
ADI-R - Autism Diagnostic Interview-Revised; K-ABC - Kaufman Assessment Battery for Children; SRS - Social Responsiveness Scale.

respectively [7]. However, these figures were derived where an effect of d = 0.24 was found. That study was
from small studies with low precision and using unpub- more similar in design to the present study but used a
lished scales [7]. A more precise estimate using the different behavioural intervention. In summary, an effect
ADOS scale may be derived from the PACT trial [6] size in the small (d = 0.20) to medium (d = 0.50) range
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may be expected [35], corresponding to a 1 to 2.5 points and finally at follow-up twelve months after randomisa-
difference on the ADOS scale that typically has SD = 5 tion. Thus, requirements such as close analysis of the
[6]. An effect size in this range would be clinically mechanism of action (i.e. how long an intervention is
meaningful as the ADOS scale measures the core symp- required to begin to have an effect) and investigation on
toms of ASD which are difficult to influence with any maintenance of any observed changes over a longer per-
treatment. iod of time [2] can be met.
Parameters for sample size calculation Primary outcome
The two music therapy arms (high- and low-intensity) To allow for potential comparison with studies investi-
will be taken together for the primary analysis to answer gating similar interventions as well as for potential
the question if music therapy in general is superior to inclusion in later reviews, a validated scale widely used
standard care. Half of all participants will be assigned to in research and academic practice will be used for
music therapy. In light of the uncertainty around the assessing social communication skills: The Autism
true effect size and the difficulty of recruiting large sam- Diagnostic Observation Schedule (ADOS) is a semi-
ples, a group sequential design (GSD, [36]) will ulti- structured, standardised observation instrument
mately ensure 80% power (two-sided alpha 0.05) even designed to assess communication, social interaction,
for a small effect, while avoiding excessively large sam- and play or imaginative use of materials using 28 to 31
ple size if there is in fact a medium effect. We used the specific behavioural criteria in one of four modules
common Lan-DeMets alpha spending function and a chosen individually depending on the respective child’s
Pocock boundary to make early stopping likely. Calcula- expressive language level and chronological age [19].
tions and simulations were made for up to four equally Inter-rater reliability, test-retest reliability, and internal
spaced looks, using East 5.4 software by Cytel Inc., 2010. validity have been demonstrated for the ADOS [19].
Results The ADOS is viewed especially suitable for this study
Table 1 shows that if there is a medium effect of music considering that, although standardised, its assessment
therapy, power at the first interim look (usable N = 235) is based on play-based interactions between assessor
will be 93%. Power will also be acceptable (76%) if the and child, thus similar in its setting to the music ther-
effect is slightly smaller than medium. If there is only a apy situation. This study’s primary outcome will be the
small effect size, power can still be retained by recruit- ADOS social communication algorithm score which
ing more participants. An independent data monitoring has been used as an outcome measure in previous
committee will perform the interim look. We will aim RCTs investigating effects of interventions for autism
to randomise N = 300 participants (150 to standard care [6,38,39]. In order to improve sensitivity to change, the
and 75 to each type of music therapy) to account for scoring procedure will be modified as in an earlier
possible drop-outs and clustering within sites [37]. How- RCT on treatment effects [6], i.e. the module applied
ever, the actual interim look may be taken at a different to each child will be the same across assessment points
sample size, depending on recruitment progress and (instead of adjusting the module to potentially devel-
funding. oped expressive language skills) to avoid discontinuity
of scores, and the full range of scores will be retained
Outcomes (instead of recoding 3’s to 2’s as in the standard diag-
The study will use assessments by blinded clinicians as nostic algorithm) [40].
well as reports by parents/guardians. Outcome variables To avoid bias in observation and assessment, assessors
will be assessed at several time points: after the baseline administering the instrument will be blinded to group
assessment (taking place before each individual’s rando- allocation of the children to be assessed. This will be
misation), the outcome measures will be reapplied after secured for example by having the assessments take
an interval of two months (intermediate), once again place in another location than music therapy sessions.
after an interval of five months (end of intervention), Success of blinding will be verified by asking assessors

Table 1 Sample size and power under different scenarios

Raw difference on the ADOS scale (SD = Standardised effect size (Cohen’s Power at first interim Test power over all 4 interim
5) d) look1 looks2
2.5 0.5 (medium effect) 93% 100%
2 0.4 76% 100%
1.5 0.3 47% 99%
1 0.2 (small effect) 20% 80%
Note. Based on 10000 simulations for each scenario. 1Usable N = 235 (300 randomised). 2Maximum usable N = 939.
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whether or not they inadvertently found out about the conditions. Inconveniences caused by the necessity to
child’s allocation. attend three weekly sessions of music therapy for the
Secondary outcomes families assigned to this study group are considered tol-
In order to supplement the assessment, parents/guar- erable in view of the anticipated benefit for the child
dians will be asked to complete the Social Responsive- receiving therapy.
ness Scale (SRS) [24] at baseline, and two, five, and
twelve months after randomisation. The 65-item rating Discussion
scale measures the severity of autism spectrum symp- High clinical applicability of this RCT’s findings is to be
toms occurring in natural social settings, assessing social achieved through therapy conditions that are close to
awareness, social information processing, capacity for clinical practice in terms of broad eligibility criteria (ver-
reciprocal social communication, social anxiety/avoid- bal and non-verbal children, all types of ASD), treat-
ance, and autistic preoccupations and traits. Defined as ment duration (several months), and therapy techniques
suitable for assessing treatment response [41], these five (improvisational music therapy conducted by experi-
subscales seem appropriate as secondary outcome mea- enced therapists in a typical setting).
sures. The scale features high inter-rater and test-retest The study’s limitations are also its strengths: The
reliability as well as internal validity rates and may be absence of outcomes proximal to music therapy [15,17];
completed in 15 to 20 minutes [42-44], thus easily the heterogeneity of standard care as a control condi-
applicable during appointments. tion; and the heterogeneity of the population [46] may
Cost-effectiveness of music therapy will be compared be seen as limitations, but are features that will improve
to standard care. Cost will be measured as real resources feasibility and that are in line with pragmatic trials of
used in treatment, in terms of personnel hours of work. effectiveness whose focus is to help users choose
Effectiveness is measured by ADOS, and cost-effective- between options [47].
ness ratios and incremental cost-effectiveness ratios for Conclusions that will emerge from this study are
the different alternatives can be calculated. Gains for the expected to contribute to the evidence base of treatment
general health care sector and society will be more long options for children with ASD. The results of the trial
term, and can hardly be included in this project. How- will provide evidence on the effectiveness of music ther-
ever, some consideration will be made as to possible apy as a treatment for ASD and will also provide infor-
effects on school attainment. Costs can be made com- mation on the relevance of session frequency for
parable across countries using purchasing power parity therapy outcome. Furthermore, findings gained through
measures. the application of a treatment guide within this study
may help to further specify music therapy treatment
Statistical analyses guidelines for this population and to enrich future train-
The primary analysis will be undertaken on an inten- ing and education of music therapists and other health
tion-to-treat basis, and two-sided tests will be applied at care professionals working in the field of ASD.
a 5% alpha level. Following assessment of normality, Findings of this study will also be relevant for other
treatment effects will be analysed using a generalized fields where music therapy is applied, such as adult
estimating equations (GEE) approach that allows for mental health [10,25], and for basic research into the
analysis of longitudinal data while accounting for the musical qualities of early mother-infant communication
correlation among the repeated observations for each providing a rationale for music therapy [18,29]. Music
subject [45]. GEE analyses will also be used to examine therapy in general is an intervention that focuses on
dose-effect relationships and to explore possible con- developing social and emotional abilities, and ASD is a
founding effects of site or relevant subgroups such as case in point because impairments in these abilities are
age or ASD subtype. central for ASD.

Ethical issues
Acknowledgements
The study protocol was approved by the Faculty of This trial is funded by The Research Council of Norway, programmes Clinical
Humanities’ Human Research Ethics Board (HREB) at Research and Mental Health (Research Council of Norway project number
Aalborg University, Denmark. Freely given, written 213982). The development of this study protocol was supported by the
Department of Communication and Psychology, Aalborg University, Aalborg,
informed consent will be obtained from participant’s Denmark (MG, UH); the Department of Applied Psychology: Health,
parents/guardians prior to study enrolment in accor- Development, Enhancement and Intervention, Faculty of Psychology,
dance with regulatory requirements. Random allocation University of Vienna, Vienna, Austria (MG); and the Grieg Academy Music
Therapy Research Centre, Uni Health, Uni Research, Bergen, Norway (CG).
of participants to study groups is considered reasonable The funding sources had no role in the study design; in the writing of the
as no adverse effects are expected in any of the manuscript; and in the decision to submit the manuscript for publication.
Geretsegger et al. BMC Pediatrics 2012, 12:2 Page 8 of 9
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Author details syndrome. In Communicative Musicality. Edited by: Trevarthen C, Malloch S.

1
Aalborg University, Faculty of Humanities, Department of Communication Oxford: Oxford University Press; 2008:423-446.
and Psychology, Aalborg Øst, Denmark. 2University of Vienna, Faculty of 19. Lord C, Rutter M, DiLavore P, Risi S: Autism Diagnostic Observation Schedule
Psychology, Department of Applied Psychology: Health, Development, (ADOS) Los Angeles: Western Psychological Services; 2001.
Enhancement and Intervention, Vienna, Austria. 3Grieg Academy Music 20. Lord C, Rutter M, Le Couteur A: Autism Diagnostic Interview-Revised: a
Therapy Research Centre (GAMUT), Uni Health, Uni Research, Bergen, revised version of a diagnostic interview for caregivers of individuals
Norway. with possible pervasive developmental disorders. J Autism Dev Disord
1994, 24:659-685.
Authors’ contributions 21. Risi S, Lord C, Gotham K, Corsello C, Chrysler C, Szatmari P, Cook EH Jr,
MG and CG conceived the study and developed the study design. MG Leventhal BL, Pickles A: Combining information from multiple sources in
drafted the manuscript. CG did the power calculation and helped to draft the diagnosis of autism spectrum disorders. J Am Acad Child Psy 2006,
the manuscript. UH contributed to the development of the study design 45:1094-1103.
and helped to draft the manuscript. All authors read and approved the final 22. Lord C, Storoschuk S, Rutter M, Pickles A: Using the ADI-R to diagnose
manuscript. autism in preschool children with autism. Inf Mental Hlth J 1993,
14:234-252.
Competing interests 23. Kaufman AS, Kaufman NL: Kaufman Assessment Battery for Children (K-ABC).
MG, UH, and CG are clinically trained music therapists. Interpretive Manual Circle Pines, MN: American Guidance Service; 1983.
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Pre-publication history
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doi:10.1186/1471-2431-12-2
Cite this article as: Geretsegger et al.: Randomised controlled trial of
improvisational music therapy’s effectiveness for children with autism
spectrum disorders (TIME-A): study protocol. BMC Pediatrics 2012 12:2.

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