Randomized controlled trial2017Industry funded

Funded in part by American Music Therapy Association

Effects of Improvisational Music Therapy vs Enhanced Standard Care on Symptom Severity Among Children With Autism Spectrum Disorder: The TIME-A Randomized Clinical Trial

Bieleninik L, Geretsegger M, Mössler K, Assmus J, Thompson G, Gattino G, Elefant C, Gottfried T, Igliozzi R, Muratori F, Suvini F, Kim J, Crawford MJ, Odell-Miller H, Oldfield A, Casey Ó, Finnemann J, Carpente J, Park AL, Grossi E, Gold C, TIME-A Study Team

JAMA · 77 citations

Review labels

Industry funded

Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.

How it was studied

Design
Randomized controlled trial (indexed by PubMed)
Studied in
People
Main outcome
Health markers and function

Who paid for it

Funding
Industry funded
Industry group
American Music Therapy Association
Government
National Institute for Health and Care Research
University or hospital
University of Melbourne
University or hospital
Jeonju University
University or hospital
Aalborg Universitet
University or hospital
Universität Wien
University or hospital
Hospital de Clínicas de Porto Alegre
Government
Helse Vest
Nonprofit
Danmarks Frie Forskningsfond
University or hospital
Universitetet i Bergen
Government
Norges Forskningsråd
Nonprofit
Fundação Instituto de Pesquisas Econômicas
University or hospital
Università di Pisa
Government
Health Technology Assessment Programme
Government
National Institute for Health Research (NIHR)
Grants
National Institute for Health and Care Research (12/167/95); Helse Vest (911800); Health Technology Assessment Programme (12/167/95); Norges Forskningsråd (213844)

Based on 15 listed funder(s).

Publication

Published
2017-08-08 · JAMA · vol. 318 · issue 6 · p. 525
Publisher
American Medical Association
Cited
197 citations · more than 98% of similar papers · 8.0× the field average
Impact
Top 10% most cited in its field
References
32 works
Access
Free to read
Research areas
Autism Spectrum Disorder Research · Family and Disability Support Research · Music Therapy and Health
Keywords
Medicine, Music therapy, Autism spectrum disorder, Improvisation, Autism, Audiology, Physical therapy, Psychiatry
MeSH
humans, treatment outcome, music therapy, single-blind method, attention, child, child, preschool, female, male, social skills, autism spectrum disorder

22 authors

From NO, AU, BR, DK, IL, IT, KR, GB, US

  • Łucja BieleninikUni Research (Norway)
  • Monika GeretseggerUni Research (Norway)
  • Karin Antonia MösslerUni Research (Norway)
  • Jörg AßmusUni Research (Norway)
  • Grace Anne ThompsonThe University of Melbourne
  • Gustavo GattinoUniversidade Federal do Rio Grande do Sul; Aalborg University

Abstract

Importance

Music therapy may facilitate skills in areas affected by autism spectrum disorder (ASD), such as social interaction and communication.

Objective

To evaluate effects of improvisational music therapy on generalized social communication skills of children with ASD.

Design, setting, and participants

Assessor-blinded, randomized clinical trial, conducted in 9 countries and enrolling children aged 4 to 7 years with ASD. Children were recruited from November 2011 to November 2015, with follow-up between January 2012 and November 2016.

Interventions

Enhanced standard care (n = 182) vs enhanced standard care plus improvisational music therapy (n = 182), allocated in a 1:1 ratio. Enhanced standard care consisted of usual care as locally available plus parent counseling to discuss parents' concerns and provide information about ASD. In improvisational music therapy, trained music therapists sang or played music with each child, attuned and adapted to the child's focus of attention, to help children develop affect sharing and joint attention.

Main outcomes and measures

The primary outcome was symptom severity over 5 months, based on the Autism Diagnostic Observation Schedule (ADOS), social affect domain (range, 0-27; higher scores indicate greater severity; minimal clinically important difference, 1). Prespecified secondary outcomes included parent-rated social responsiveness. All outcomes were also assessed at 2 and 12 months.

Results

Among 364 participants randomized (mean age, 5.4 years; 83% boys), 314 (86%) completed the primary end point and 290 (80%) completed the last end point. Over 5 months, participants assigned to music therapy received a median of 19 music therapy, 3 parent counseling, and 36 other therapy sessions, compared with 3 parent counseling and 45 other therapy sessions for those assigned to enhanced standard care. From baseline to 5 months, mean ADOS social affect scores estimated by linear mixed-effects models decreased from 14.08 to 13.23 in the music therapy group and from 13.49 to 12.58 in the standard care group (mean difference, 0.06 [95% CI, -0.70 to 0.81]; P = .88), with no significant difference in improvement. Of 20 exploratory secondary outcomes, 17 showed no significant difference.

Conclusions and relevance

Among children with autism spectrum disorder, improvisational music therapy, compared with enhanced standard care, resulted in no significant difference in symptom severity based on the ADOS social affect domain over 5 months. These findings do not support the use of improvisational music therapy for symptom reduction in children with autism spectrum disorder.

Trial registration

isrctn.org Identifier: ISRCTN78923965.

Abstract via Europe PMC. Copyright remains with the authors or publisher.

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