Study protocol of a randomized control trial on the effectiveness of improvisational music therapy for autistic children.

Researchers are planning a large study with 200 autistic children aged 7-11 to test whether music therapy helps improve communication skills and reduces anxiety. Half the children will receive 12 weeks of music therapy alongside their usual support, while the other half will only receive usual support. The study will track changes over time to see if music therapy makes a difference in how children communicate and how they feel.

This study protocol describes a planned randomized controlled trial investigating improvisational music therapy for autistic children aged 7-11 years in the UK. The trial will include 200 participants randomly assigned to either 12 weeks of improvisational music therapy plus support as usual, or support as usual alone. The primary outcome measure is the Brief Observation of Social Communication Change (BOSCC), with assessments at baseline, 13 weeks, and 39 weeks. Secondary measures include anxiety, wellbeing, adaptive behaviour, and communication skills.

The study aims to determine if music therapy can improve social communication and wellbeing while reducing anxiety in autistic children, using both human and AI-driven analysis of therapy sessions.

Once completed, this well-designed RCT may provide important evidence about improvisational music therapy effectiveness for autistic children. The comprehensive assessment approach and follow-up periods could inform clinical practice and policy decisions regarding music therapy interventions in autism support services.

This is a study protocol only - no actual results or findings are reported. The effectiveness of the intervention remains to be determined through the planned trial execution.

Music therapy is the clinical use of musical interventions to improve mental and physical health across multiple domains, including social communication. Autistic children, who have difficulties in social communication and often increased anxiety, tend to show a strong preference for music, because it can be structured and systematic, and therefore more predictable than social interaction. This makes music therapy a promising medium for therapeutic support and intervention. Previous clinical trials of music therapy compared to traditional therapy for autistic children have shown encouraging but nevertheless mixed results.

The primary aim is to conduct a randomised controlled trial (RCT) of improvisational music therapy for autistic children and test its effectiveness in at improving social communication and wellbeing, and to reduce anxiety. The RCT will be conducted with 200 autistic children in the UK aged 7 to 11 years old. Participants will be randomly assigned to either improvisational music therapy or support as usual. The trial will be an assessor-blind, pragmatic two-arm cluster RCT comparing the impact of 12-weeks of improvisational music therapy in addition to support as usual, vs. support as usual for autistic children.

Researchers who are blind to which arm the children are in will conduct assessments and obtain data via caregiver reports. The primary outcome will be the absolute change in the total score of the Brief Observation of Social Communication Change (BOSCC) assessed at baseline, T1 (13 weeks) and T2 (39 weeks) follow-ups. The BOSCC consists of specific items that were developed to identify changes in social-communication behaviours. Secondary outcome measures include: (1) Parent reported anxiety scale for youth with ASD (Note that we do not use the term 'ASD' or Autism Spectrum Disorder, because many autistic people feel it is stigmatising.

Instead, we use the term 'autism') (PRAS-ASD) (2) Young Child Outcome Rating Scale, for wellbeing (YCORS), (3) Strengths and Difficulties Questionnaire (SDQ); and (4) Vineland Adaptive Behaviour Scale (VABS). (5) The Children's Communication Checklist-2 (CCC-2) will be completed to evaluate pragmatic speech with fluent speakers only; (6) The Music Engagement Scale (MES); and (7) Assessment of the Quality of Relationship (AQR) will be used to evaluate the child-therapist relationships using video-analysis of music therapy sessions. Additional data will be collected by administering the Wechsler Abbreviated Scale of Intelligence (WASI-II), Music at Home Questionnaire (M@H), and children's versions of the Empathy Quotient (EQ) and Systemizing Quotient (SQ). Audio and video data from the therapy sessions will be collected and analysed (using both human and computer-based feature-coding, e.g., machine learning and AI-driven methods) to identify how music and non-musical interactions foster change throughout the therapy. This study aims to observe if the interactions, engagement, and therapeutic modalities fostered during music therapy sessions can translate to non-musical contexts and improve autistic children's social communication skills, identifying possible mediating factors contributing to the effectiveness of music therapy, potentially informing policy making and governance.

This randomised control trial is registered with the NIH U.S. National Library of Medicine: https://clinicaltrials.gov/search?term=NCT06016621 , clinicalTrials.gov Identifier: NCT0601662, Registration Date 19th August 2023.