Music for Autism (M4A)
NCT04936048 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68
Last updated 2025-04-04
Summary
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.
Conditions
Interventions
- BEHAVIORAL
-
Music Therapy
Music therapy will use rhythmic cues, music instruments (piano, drums, djembe, xylophone, harmonica), songs, and stories accompanied by songs or musical instruments to target common goals.
- BEHAVIORAL
-
Play therapy
Play therapy is designed as a play-based active comparison condition to control for factors such as support, therapist attention, positive expectancies, and emotional engagement. It will use verbal interaction, toys (Lego, finger puppets, Play Doh, puzzles), and the same stories as in MT, but without a musical component, to target common goals.
Sponsors & Collaborators
-
University of Bergen
collaborator OTHER -
University of Vienna
collaborator OTHER -
NORCE Norwegian Research Centre AS
lead OTHER
Principal Investigators
-
Christian Gold, PhD · NORCE Norwegian research Centre
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 6 Years
- Max Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-08-01
- Primary Completion
- 2024-12-17
- Completion
- 2024-12-31
Countries
- Austria
- Norway
Study Locations
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