Condition category
Mental and Behavioural Disorders
Date applied
03/01/2020
Date assigned
10/02/2020
Last edited
16/09/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

Background and study aims
This study addresses a fundamental, so far unanswered question: is Music Therapy more effective than just music listening? This question is very important, because its answer has so far only been assumed, and could encourage or discourage the use of music therapy. The question is addressed through a trial of music therapy compared to music listening for children with autism spectrum disorders. The number of participants and intervention length (25 sessions over 8 months) raises the standards of existing, similar studies.

Who can participate?
Children aged 4 to 7 years with a diagnosis of ASD

What does the study involve?
The study involves either 25 sessions of music therapy with a qualified music therapist or 25 sessions of music listening with no therapy. These 25 sessions take place over a period of 8 months and at the start and end of the study, participants will be evaluated on the basis of overall functioning and autistic symptom severity.

What are the possible benefits and risks of participating?
There are no known risks of musicotherapy for children suffering from autism disorder. The potential benefits are improvements in social skills and speech expression and reduced anxieties and repetitive behaviors.

Where is the study run from?
Nantes Child Psychiatric Hospital (France)

When is the study starting and how long is it expected to run for?
May 2014 to June 2015

Who is funding the study?
Entreprendre pour Aider (France) and the Académie Française (France)

Who is the main contact?
Professor Thomas Rabeyron
Thomas.rabeyron@univ-lorraine.fr

Trial website

Contact information

Type

Scientific

Primary contact

Prof Thomas Rabeyron

ORCID ID

http://orcid.org/0000-0003-4117-4683

Contact details

23 Boulevard Albert Premier
Nancy
54000
France
+33 372743058
Thomas.rabeyron@univ-lorraine.fr

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

010914

Study information

Scientific title

A randomized controlled trial of 25 sessions of music therapy in autism spectrum disorders: MUSICAUTISM

Acronym

MUSICAUTISM

Study hypothesis

Music Therapy will be more effective than Music Listening in general clinical evaluations.

Music Therapy will be more effective than Music Listening in general clinical evaluations for symptoms related to interactions in ASD-specific dimensions

Ethics approval

Approved 12/05/2014, the ethics committee of the Nantes University Hospital Centre (5 allée de l’ile gloriette 44000 Nantes Immeuble Jean Monnet, RH, 30 boulevard Jean Monnet 44093 Nantes Cedex 1; bp-uupea@chu-nantes.fr; +33 0253482653), ref: 015321653

Study design

An interventional, longitudinal, single-centre, single-blinded, randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Autism spectrum disorders

Intervention

Children were randomly assigned to one of the two groups: music therapy (MT) or music listening (ML), using a generated randomization list for each group.

At enrolment baseline evaluations to assess global functioning took place.

Half of the participants were assigned to the MT group where they received 25 sessions of MT with a qualified music therapist. The other half were assigned to the ML group which involved 25 sessions of ML with no therapeutic intervention. The 25 sessions for each group took place over a period of 8 months.

A second evaluation was performed for both groups after 8 months.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Improvement in patient global functioning measured by the Clinical Global Impressions Scale (CGI) at baseline and 8 months

Secondary outcome measures

Autistic symptom severity measured by the Childhood Autism Rating Scale (CARS) and the Autism Behaviour Checklist (ABC) at baseline and 8 months

Overall trial start date

01/05/2014

Overall trial end date

06/06/2015

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Childhood Autism Rating Scale (CARS)-validated diagnosis of ASD
2. Aged 4 to 7 years

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

37

Total final enrolment

36

Participant exclusion criteria

1. Auditory impairment
2. Known somatic and neurological diseases (with the exception of stabilized epilepsy)
3. Psychotropic medication that was modified less than 6 months prior to the study
4. Behavioral disturbance incompatible with an MT or ML session

Recruitment start date

01/07/2014

Recruitment end date

01/09/2014

Locations

Countries of recruitment

France

Trial participating centre

Nantes Child Psychiatric Hospital
Immeuble Jean Monnet RH 30 boulevard Jean Monnet
Nantes
44093 Nantes Cedex 1
France

Sponsor information

Organisation

Unité universitaire de psychiatrie de l'enfant et de l'adolescent

Sponsor details

Immeuble Jean Monnet
RH
30 boulevard Jean Monnet
Nantes
44093 Nantes Cedex 1
France
+33 0253482653
olivier.bonnot@gmail.com

Sponsor type

Hospital/treatment centre

Website

https://www.chu-nantes.fr/unite-universitaire-de-psychiatrie-de-l-enfant-et-de-l-adolescent-37370.kjsp

Funders

Funder type

Charity

Funder name

Entreprendre pour Aider

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Academie Francaise

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The Journal of Child Psychology and Psychiatry

IPD sharing statement:
The datasets generated during and/or analyzed during the current study are/will be available upon request from Juan-Pablo Robledo del Canto. Datasets consist of Excel files containing the different measurements at t0 and t1. Raw data for all measurements and analysis will be sent by mail. Because consent was obtained from participants, anonymized data will be shared at the researcher’s discretion.

Intention to publish date

15/01/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

2020 results in https://doi.org/10.1016/j.psychres.2020.113377 (added 16/09/2020)

Publication citations

Additional files

Editorial Notes

16/09/2020: The following changes have been made: 1. Publication reference added. 2. The final enrolment number has been added from the reference. 03/02/2020: Trial’s existence confirmed by the University Unit of Child and Adolescent Psychiatry of the Nantes University Hospital Centre.