Effects of improvisational music therapy vs enhanced standard care on symptom severity among children with autism spectrum disorder

The TIME-A randomized clinical trial

Łucja Bieleninik, Monika Geretsegger, Karin Mössler, Jörg Assmus, Grace Thompson, Gustavo Gattino, Cochavit Elefant, Tali Gottfried, Roberta Igliozzi, Filippo Muratori, Ferdinando Suvini, Jinah Kim, Mike J. Crawford, Helen Odell-Miller, Amelia Oldfield, Órla Casey, Johanna Finnemann, John Carpente, A. La Park, Enzo Grossi & 5 others Christian Gold, TIME-A Study Team, Fabio Apicella, Antonio Narzisi, Raffaella Tancredi

Research output: Contribution to journalArticle

21 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)525-535
Number of pages11
JournalJAMA - Journal of the American Medical Association
Volume318
Issue number6
DOIs
Publication statusPublished - Aug 8 2017

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Music Therapy
Randomized Controlled Trials
Autistic Disorder
Counseling
Appointments and Schedules
Observation
Music
Communication
Autism Spectrum Disorder
Standard of Care
Interpersonal Relations
Parents

ASJC Scopus subject areas

  • Medicine(all)

Cite this

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, Órla; Finnemann, Johanna; Carpente, John; Park, A. La; Grossi, Enzo; Gold, Christian; TIME-A Study Team ; Apicella, Fabio; Narzisi, Antonio; Tancredi, Raffaella.

In: JAMA - Journal of the American Medical Association, Vol. 318, No. 6, 08.08.2017, p. 525-535.

Research output: Contribution to journalArticle

Bieleninik, Ł, 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, Apicella, F, Narzisi, A & Tancredi, R 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 - Journal of the American Medical Association, vol. 318, no. 6, pp. 525-535. https://doi.org/10.1001/jama.2017.9478
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, Órla ; Finnemann, Johanna ; Carpente, John ; Park, A. La ; Grossi, Enzo ; Gold, Christian ; TIME-A Study Team ; Apicella, Fabio ; Narzisi, Antonio ; Tancredi, Raffaella. / Effects of improvisational music therapy vs enhanced standard care on symptom severity among children with autism spectrum disorder : The TIME-A randomized clinical trial. In: JAMA - Journal of the American Medical Association. 2017 ; Vol. 318, No. 6. pp. 525-535.
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T1 - Effects of improvisational music therapy vs enhanced standard care on symptom severity among children with autism spectrum disorder

T2 - The TIME-A randomized clinical trial

AU - Bieleninik, Łucja

AU - Geretsegger, Monika

AU - Mössler, Karin

AU - Assmus, Jörg

AU - Thompson, Grace

AU - Gattino, Gustavo

AU - Elefant, Cochavit

AU - Gottfried, Tali

AU - Igliozzi, Roberta

AU - Muratori, Filippo

AU - Suvini, Ferdinando

AU - Kim, Jinah

AU - Crawford, Mike J.

AU - Odell-Miller, Helen

AU - Oldfield, Amelia

AU - Casey, Órla

AU - Finnemann, Johanna

AU - Carpente, John

AU - Park, A. La

AU - Grossi, Enzo

AU - Gold, Christian

AU - TIME-A Study Team

AU - Apicella, Fabio

AU - Narzisi, Antonio

AU - Tancredi, Raffaella

N1 - Extracted concepts Music Therapy Autism Spectrum Disorder

PY - 2017/8/8

Y1 - 2017/8/8

N2 - 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.

AB - 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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