NCT04936048Completed
Music for Autism (M4A)
Music for Autism: Binational Randomised Controlled Trial of Music Therapy Versus Play Therapy for Autistic Children
Source: ClinicalTrials.gov · Last updated 4 Apr 2025
Brief summary (registry, in English)
The Music for Autism (M4A) trial evaluates the neurobehavioral outcomes of a music therapy (MT) intervention, compared to a matched play therapy (PT) intervention, on social communication skills, brain connectivity and structural brain changes. In a crossover randomised controlled trial (RCT), 80 children with autism across all levels of functioning, aged 6-12 years, undergo a baseline assessment, which includes measurements of social communication, participation, functional connectivity and brain structure. Participants are then randomly allocated to a sequence of interventions (MT-PT or PT-MT) and assessments are taken before and after each intervention period. Both interventions will target common goals and follow the same structure, while at the same time allowing for flexibility in the therapists' approach. It is hypothesized that 12 weeks of intervention through MT, compared to PT, will improve social communication skills, participation, and other relevant mental health outcomes in children with autism spectrum disorder (ASD), as well as regulate resting-state functional over and under-connectivity and increase grey and white matter volume in specified regions. The investigators also expect changes in functional brain connectivity to correlate with behavioural outcome measures, specifically with improved social communication skills.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 68 (actual)
- First submitted
- 14 Jun 2021
- Start date
- 1 Aug 2021
- Primary completion date
- 17 Dec 2024
- Lead sponsor
- NORCE Norwegian Research Centre AS
- Diseases
- Autism
- NCT number
- NCT04936048
What you commit to
- Study type: Interventional
- Participants enrolled: 68
- From 1 Aug 2021 to the primary completion date, 17 Dec 2024
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent or current music therapy
- Metallic or electronic implants
Who the study is looking for
- Meet diagnostic criteria as specified in Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-V) and officially diagnosed with autism spectrum disorder (ASD) by a licensed clinical professional using standardised diagnostic tools (Autism Diagnostic Observation Schedule (ADOS), Autism Diagnostic Interview Revised (ADI-R)).
Age in the registry: 6 years to 12 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| NORCE Norwegian Research Centre Coordinator of this site? Confirm its status | Bergen | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.