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

Educational Objective
To learn whether improvisational music therapy can improve social communication skills in children with autism spectrum disorder.
1 Credit CME
Key Points

Question  Does improvisational music therapy improve symptom severity of children with autism spectrum disorder?

Findings  In a randomized clinical trial of 364 children in 9 countries, mean autism severity, as measured on the Autism Diagnostic Observation Schedule, social affect domain, over 5 months, was reduced from 14.08 to 13.23 in the improvisational music therapy group and from 13.49 to 12.58 in the enhanced standard care group, which included parent counseling and other available interventions, a nonsignificant mean difference of 0.06.

Meaning  In children with autism spectrum disorder, music therapy did not result in significant improvements in mean symptom scores compared with enhanced standard care.

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

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Article Information

Corresponding Author: Christian Gold, PhD, GAMUT—The Grieg Academy Music Therapy Research Centre, Uni Research Health, Uni Research, Postbox 7805, 5020 Bergen, Norway (christian.gold@uni.no).

Accepted for Publication: July 5, 2017.

Author Contributions: Drs Assmus and Gold had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Geretsegger, Assmus, Gold.

Acquisition, analysis, or interpretation of data: Bieleninik, Geretsegger, Mössler, Assmus, Thompson, Gattino, Elefant, Gottfried, Igliozzi, Muratori, Suvini, Kim, Crawford, Odell-Miller, Oldfield, Casey, Finnemann, Carpente, Park, Grossi, Gold.

Drafting of the manuscript: Bieleninik, Geretsegger, Assmus, Gold.

Critical revision of the manuscript for important intellectual content: Geretsegger, Mössler, Assmus, Thompson, Gattino, Elefant, Gottfried, Igliozzi, Muratori, Suvini, Kim, Crawford, Odell-Miller, Oldfield, Casey, Finnemann, Carpente, Park, Grossi, Gold.

Statistical analysis: Assmus, Finnemann, Park, Grossi, Gold.

Obtained funding: Geretsegger, Mössler, Thompson, Kim, Crawford, Odell-Miller, Gold.

Administrative, technical, or material support: Bieleninik, Geretsegger, Mössler, Thompson, Gattino, Kim, Crawford.

Supervision: Thompson, Gattino, Igliozzi, Muratori, Suvini, Kim, Crawford, Odell-Miller, Oldfield, Carpente, Gold.

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.

Funding/Support: This trial was funded by the Research Council of Norway (grant 213844, the Clinical Research and Mental Health Programmes). Additional funding was provided by the POLYFON Knowledge Cluster for Music Therapy, The Grieg Academy Department of Music, University of Bergen. Funding for the individual countries came from the following sources: Australia:Melbourne Conservatorium of Music, The University of Melbourne; Austria:Danish Council for Independent Research/Humanities (FKK), Aalborg University, and Faculty of Psychology, University of Vienna; Brazil:Research Incentive Fund (FIPE) of the Hospital de Clínicas de Porto Alegre (HCPA); Italy:IRCCS Stella Maris Foundation, Pisa, and University of Pisa; Korea:Research Institute of Health and Science, Jeonju University; Norway:Health Authority of Western Norway (Helse Vest grant 911800), Bergen municipality (Bergen Culture School), Fjell municipality (Fjell Culture School); United Kingdom:National Institute for Health Research (Health Technology Assessment Programme, National Institute for Health Research grant 12/167/95), Cambridge and Peterborough Foundation National Health Service Trust, The Evelyn Trust, Cambridgeshire Music, Anglia Ruskin University; United States:Molloy College Faculty research scholarship and a collaborative research grant from the Mid-Atlantic Region of the American Music Therapy Association.

Role of the Funder/Sponsor: The funders of the study had no role in design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript or the decision to submit for publication.

Group Information: TIME-A Study Team:Australia: Music therapists: Anna-Lee Robertson, MMusThrp, Jo Rimmer, BMusThrp, Grace Thompson, PhD; Clinical assessor: Melina Roberts, MMus; Parent counselor: Grace Thompson, PhD (University of Melbourne). Austria: Music therapists: Agnes Burghardt-Distl, MMag, Monika Geretsegger, MMMag, PhD (private practice); Clinical assessors: Sonja Metzler, Mag, Carolin Steidl, Mag (Österreichische Autistenhilfe); Parent counselor: Monika Geretsegger, MMMag, PhD (private practice). Brazil: Music therapist and parent counselor: Gustavo Andrade de Araujo, PhD (Universidade Federal do Rio Grande do Sul); Clinical assessors: Renata Rocha Kieling, PhD (Santa Casa Hospital), Gabriela Damasceno Ferreira (clinical psychologist), Barbara Backes, PhD, Regina Zanon, PhD (Universidade Federal do Rio Grande do Sul); ADI-R supervisor: Cleonice Bosa, PhD (Universidade Federal do Rio Grande do Sul). Rudimar Riesgo, PhD (Universidade Federal do Rio Grande do Sul) helped with translating and validating the SRS and with obtaining permission for using the ADOS, ADI-R, and SRS in Brazil. Israel: Music therapists and parent counselors: Tali Gottfried, PhD (private practice), Rivka Grossbard, MA (University of Haifa); Clinical assessors: Efrat Eshchar, MA, Edwa Friedlander, MA (University of Haifa). Italy: Music therapists: Stefano Cainelli, diploma in music therapy (University of Trento), Giulio Collavoli, MA, Marco Giusti, MS (IRCCS Stella Maris Foundation, Pisa); Clinical assessors: Fabio Apicella, PhD, Romina Cagiano, MS, Roberta Igliozzi, PhD, Patrizia Masoni, MD, Antonio Narzisi, PhD, Gloria Scarselli, MD, Raffaella Tancredi, MD (IRCCS Stella Maris Foundation, Pisa), Arianna Bentenuto, PhD, Alessandro Carolli, MS, Annarita Contaldo, MD, Michela Zaninelli, MS (University of Trento); Parent counselors: Sara Baldini, PhD, Ferdinando Suvini, MA (IRCCS Stella Maris Foundation, Pisa), Paola Venuti, PhD (University of Trento). Korea: Music therapists: Silvina Choi, MA, Sungha Hwang, MA, Su-A Kim, MA, Ji- Yeon Lee, MA (Love’n Family Music Therapy Center); Clinical assessor: HyunKyung Lee, MA, Eun-Chung Lim, MA (Rudolf—The Korea Institute for Children’s Social Development); Clinical assessor, advisor, help with recruitment: Yun-Joo Koh, PhD (Rudolf—The Korea Institute for Children’s Social Development); Parent counselors: In-Yong Lee, PhD (Gachon University), In-Ryung Song, PhD, Ji-Yeon Lee, MA (Love’n Family Music Therapy Center). Norway: Music therapists and parent counselors: Trond Dahle, MA (PPS Sør, Bergen), Åsta Rosendahl Knudsen, MA (Bergen Culture School), Olena Svatyeva, MA (Fjell Culture School); Parent counselor: Karin Mössler, Drscmus (Uni Research); Clinical assessors: Elin Antoniussen, Stine Mjåtvedt, Line Beate Ulstein, Kjellaug Grøsvik (all candidates in psychology; Haukeland University Hospital); Advisors: Irene Elgen, MD (Haukeland University Hospital), Gun Iversen (candidate in psychology; Haukeland University Hospital). United Kingdom: Music therapists: Laura Blauth, MA, Alexandra Georgaki, MA, Órla Casey, MA (Anglia Ruskin University), Belinda Lydon, MA, Pavlina Papadopoulou, MA, Grace Watts, MA (Central and North West London NHS Foundation Trust); Music therapy supervisors: Claire Grant, MA, Anna Maratos, MS (Central and North West London NHS Foundation Trust), Stephen Sandford, MA (East London NHS Foundation Trust), Amelia Oldfield, PhD (Anglia Ruskin University); Clinical assessors: Sarah Faber, MA, Johanna Finnemann, MA, MRes (Anglia Ruskin University), Lavanya Thana, BS (Imperial College London); Parent counselors: Adewale Adeoye, MBBS (Cambridge and Peterborough NHS Foundation Trust), Laura Blauth, MA, Órla Casey, MA, Alexandra Georgaki, MA, Sonia Yin, MA (Anglia Ruskin University), Arshad Faridi, MBBS, Belinda Lydon, MA, Rania Moussa, MBBS (Central and North West London NHS Foundation Trust); Study administrator: Amy Claringbold, BSc (Imperial College London). United States: Music therapists: Tal Gur, MA (Brooklyn Conservatory of Music), Jesse Asch, MS, Michael Kelliher, MS, Jill Mulholland, MS, Gabriela Ortiz, MS, Suzanne Sorel, DA (Molloy College); Clinical assessors: Kim Gilbert, PhD (Hofstra University), Laura De Gennaro, PsyD, Alan Wenderoff, PsyD (Molloy College); Parent counselors: Audra Cerruto, PhD, Talita Ferrara, MS, Laura Kestemberg, PsyD, Ellana Sanders, MA (Molloy College); Filmers/data archivists: Diana Abourafeh, BS, Jon Fessenden, MS (Molloy College), and Molloy College music therapy students and graduate assistants; Adviser: Stella Manne, PhD (Molloy College); Administrative assistant: Stephanie Cestaro (Molloy College).

Reproducible Research Statement: Deidentified individual participant data for this study are available in the Norwegian Centre for Research Data (NSD) public repository at http://dx.doi.org/10.18712/NSD-NSD2466-V1.

Disclaimer: The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Health Technology Assessment programme, National Institute for Health Research, National Health Service, or the Department of Health.

Additional Contributions: We thank all families participating in the study and the referring professionals. Maj-Britt Posserud, MD (Haukeland University Hospital), and Karin Schumacher, Drscmus (Berlin University of the Arts), helped with the design of the study. Jan-Erik Askildsen, Dr oecon (Uni Research and University of Bergen), Barbara Barrett, PhD (King’s College London), Egil Kjerstad, PhD (Uni Research), and Ingrid Zechmeister-Koss, Drrer.soc.oec, MA (European Centre for Social Welfare Policy and Research), helped with specific aspects concerning concomitant treatments and economic analyses. Synne Rotvold Røli and Kjetil Andreas Nydal (University of Bergen) helped with assessment of treatment fidelity. Marko Nouwens, MA (Uni Research), and Jo Dugstad Wake, PhD (Uni Research), helped with data management. Leif Edvard Aarø, PhD (Norwegian Institute of Public Health, Department of Health Promotion), Tine Nordgreen, PhD (Division of Psychiatry, Haukeland University Hospital; Department of Clinical Psychology, Faculty of Psychology, University of Bergen), and Otto R. Smith, PhD (Department of Health Promotion, Norwegian Institute of Public Health), served on the data monitoring committee. Laura Fusar-Poli, MD (University of Pavia), provided valuable comments on an earlier version of the manuscript. With the exception of Ms Røli, Mr Nydal, and Mr Nouwens, none of these people received compensation for their role in the study. Drs Assmus and Gold conducted and are responsible for the data analysis; Dr Grossi provided additional analyses.

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