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
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
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