Music for Autism (M4A)

NCT04936048 | Completed DMC

• 1 other identifier: M4A
• Study Type: interventional
• Target: 68
• Locations: 2 countries
• Sites: 2

Brief 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

Autism Spectrum Disorder; Autism

Keywords

crossover randomised controlled trial; music therapy; autism spectrum disorder; functional connectivity; functional magnetic resonance imaging (fMRI); social communication; grey and white matter

Outcome Measures

Primary Outcomes (2)

• Children's Communication Checklist-2

  The Children's Communication Checklist-2 is a measure designed to assess the communication skills of children. The caregiver-report scale measures aspects of pragmatic communication with 70 items across 10 subdomains. The standard general communication composite standard score will be used as a measure of a child's general pragmatics and communication ability. Scores on the general composite of the Children's Communication Checklist-2 have a mean of 100 (SD=15). Higher scores indicate better social-communication skills.

  12 weeks

• Brain connectivity of frontotemporal regions

  Brain connectivity of frontotemporal regions will be measured as resting state functional connectivity (rsFC) from 6 seeds, will be used as the main neuroscientific outcome. Seeds will be anatomically defined regions of interest (ROIs) in Montreal Neurological Institute space for the left and right Heschl's gyrus, inferior frontal gyrus, and temporal pole.

  12 weeks

Secondary Outcomes (7)

• Child and Adolescent Scale of Participation

  12 weeks

• Beach Center Family Quality of Life Scale

  12 weeks

• Peabody Picture Vocabulary Test- 4th edition

  12 weeks

• Social Responsiveness Scale

  12 weeks

• Vineland Adaptive Behavior Scales

  12 weeks

Study Arms (2)

Music therapy/Play therapy

ACTIVE COMPARATOR

This sequence of interventions begins with 12 weeks of music therapy intervention, followed by a 3 month washout period and concluding with 12 weeks of play therapy intervention. Both interventions will consist of 12 weekly one-on-one sessions, 45 minutes each, conducted in the same setting by a licensed music therapist, in accordance with an intervention manual. Using a theoretically motivated approach, both interventions will target similar domains: creating a shared experience, building meaningful relationships, fostering self-expression. A varied set of activities combining therapist- and child-led interactions will target common goals: multisensory integration, verbal and social communication, emotion regulation, turn-taking, social appropriateness, and interaction. In both interventions, children can choose 4 activities per session using a visual schedule.

Behavioral: Music Therapy; Behavioral: Play therapy

Play therapy/Music therapy

ACTIVE COMPARATOR

This sequence of interventions begins with 12 weeks of play therapy intervention, followed by a 3 month washout period and concluding with 12 weeks of music therapy intervention. Both interventions will consist of 12 weekly one-on-one sessions, 45 minutes each, conducted in the same setting by a licensed music therapist, in accordance with an intervention manual. Using a theoretically motivated approach, both interventions will target similar domains: creating a shared experience, building meaningful relationships, fostering self-expression. A varied set of activities combining therapist- and child-led interactions will target common goals: multisensory integration, verbal and social communication, emotion regulation, turn-taking, social appropriateness, interaction. In both interventions, children can choose 4 activities per session using a visual schedule.

Behavioral: Music Therapy; Behavioral: Play therapy

Interventions

Music Therapy BEHAVIORAL

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.

Music therapy/Play therapy; Play therapy/Music therapy

Play therapy BEHAVIORAL

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.

Music therapy/Play therapy; Play therapy/Music therapy

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)).

You may not qualify if:

• Recent or current music therapy
• Metallic or electronic implants

Sponsors & Collaborators

• NORCE Norwegian Research Centre AS: lead
• University of Bergen: collaborator
• University of Vienna: collaborator

Study Sites (2)

University of Vienna

Vienna, Austria

Location

NORCE Norwegian Research Centre

Bergen, Norway

Location

Related Publications (2)

• Ruiz M, Groessing A, Guran A, Kocan AU, Mikus N, Nater UM, Kouwer K, Posserud MB, Salomon-Gimmon M, Todorova B, Wagner IC, Gold C, Silani G, Specht K. Music for autism: a protocol for an international randomized crossover trial on music therapy for children with autism. Front Psychiatry. 2023 Oct 2;14:1256771. doi: 10.3389/fpsyt.2023.1256771. eCollection 2023.

  PMID: 37886114 DERIVED

• Geretsegger M, Fusar-Poli L, Elefant C, Mossler KA, Vitale G, Gold C. Music therapy for autistic people. Cochrane Database Syst Rev. 2022 May 9;5(5):CD004381. doi: 10.1002/14651858.CD004381.pub4.

  PMID: 35532041 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Communication

Interventions

Music Therapy; Play Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Christian Gold, PhD

  NORCE Norwegian research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: To ensure blinding, the primary outcome measure will be completed by special educators who are familiar with the child (rather than their parents). Success of blinding (for all outcomes) will be verified at the last follow-up.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: M4A is designed as an assessor blinded crossover RCT, comparing music therapy (MT) to a structurally matched play therapy (PT) intervention. Following the baseline assessment, a concealed random allocation to a sequence of interventions (MT-PT or PT-MT) will be implemented by one researcher who does not have contact with participants. Each intervention has a duration of 3 months and includes a 3 month washout period between interventions. Baseline assessments will be conducted before each intervention period.

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 23, 2021
• Study Start: August 1, 2021
• Primary Completion: December 17, 2024
• Study Completion: December 31, 2024
• Last Updated: April 4, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Permanent, from the date of publication.
• Access Criteria: De-identified clinical data will be stored in a publicly available repository (Open Science Foundation, https://osf.io/).

Locations

AU (1); NO (1)