NCT04936048: M4A

Music for Autism (M4A)

Completed NA Last updated 4 April 2025

What this trial tests

NA trial testing Music Therapy in Autism Spectrum Disorder in 68 participants. Completed in 31 December 2024.

Timeline

1 August 2021

Primary endpoint
17 December 2024

31 December 2024

Quick facts

Lead sponsor	NORCE Norwegian Research Centre AS
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	68
Start date	1 August 2021
Primary completion	17 December 2024
Estimated completion	31 December 2024
Sites	2 locations across Austria, Norway

Drugs / interventions tested

• Music Therapy
• Play therapy

Conditions studied

• Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →
• Autism — all drugs for Autism →

Sponsor

NORCE Norwegian Research Centre AS

Who can join

Adults 6 to 12, any sex, with Autism Spectrum Disorder or Autism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Music therapy for autistic people.
   Geretsegger M, Fusar-Poli L, Elefant C, Mössler KA, et al · · 2022 · cited 43× · PMID 35532041 · DOI 10.1002/14651858.cd004381.pub4
2. Music for autism: a protocol for an international randomized crossover trial on music therapy for children with autism.
   Ruiz M, Groessing A, Guran A, Koçan AU, et al · · 2023 · cited 2× · PMID 37886114 · DOI 10.3389/fpsyt.2023.1256771
3. Design and implementation of a replication study: The Music for Autism (M4A) binational assessor-blinded randomised crossover trial
   Groessing A, Ruiz M, Guran A, Koçan A, et al · · 2023 · DOI 10.21203/rs.3.rs-2478719/v1