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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, Łucja, Geretsegger, Monika, Mössler, Karin, Assmus, Jörg, Thompson, Grace, Gattino, Gustavo, Elefant, Cochavit, Gottfried, Tali, Igliozzi, Roberta, Muratori, Filippo, Suvini, Ferdinando, Kim, Jinah, Crawford, Mike J., Odell-Miller, Helen, Oldfield, Amelia, Casey, Orla, Finnemann, Johanna, Carpenter, John, Park, A-La ORCID: 0000-0002-4704-4874, Grossi, Enzo, Gold, Christian and TIME-A Study Team, (2017) Effects of improvisational music therapy vs enhanced standard care on symptom severity among children with autism spectrum disorder: the TIME-A randomized clinical trial. JAMA, 318 (6). pp. 525-535. ISSN 0098-7484

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Identification Number: 10.1001/jama.2017.9478


IMPORTANCE Music therapymay 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. Childrenwere 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 outcomewas 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 Identifier: ISRCTN78923965

Item Type: Article
Official URL:
Additional Information: © 2017 American Medical Association
Divisions: Personal Social Services Research Unit
Subjects: M Music and Books on Music > M Music
R Medicine > RA Public aspects of medicine > RA0421 Public health. Hygiene. Preventive Medicine
Date Deposited: 17 Aug 2017 11:26
Last Modified: 20 Jun 2024 03:15
Projects: 213844, 911800
Funders: Research Council of Norway, University of Bergen, University of Melbourne, Danish Council for Independent Research/Humanities, Aaalborg University, University of Vienna, Hospital de Clínicas de Porto Alegre, IRCCS Stella Maris Foundation, University of Pisa, Jeonju University, Health Authority of Western Norway, National Institute for Health Research, American Music Therapy Association

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