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Full title: Child Improvisational Music Therapy Effectiveness Randomised Controlled Trial for autistic children aged 7-11

The Autism-CHIME trial is a randomised controlled trial to evaluate the effectiveness of individual sessions of improvisational music therapy to support autistic children develop their social communication skills.

A primary school aged boy sitting on the floor with a row of different-coloured handbells. There is a freestanding keyboard in the background.

Autistic children can have difficulties in social communication. Joint attention and turn-taking are necessary behaviours for social interaction and occur naturally in music-making, making them fundamental elements of music therapy.

The increased attention and enjoyment that is observed when people are presented with musical stimuli, as compared to verbal stimuli alone, helps build a strong rationale for implementing music therapy in autistic children.

Music therapy may harness the power of music to provide an alternative means to learn about and develop communication skills and relationships. Small scale studies suggest that music therapy may help autistic children, but so far this has not been demonstrated in a large-scale study of music therapy for autistic children.

This study is designed to determine whether individual sessions of improvisational music therapy improves social communication in autistic children. It will also look at the impact of music therapy on anxiety and well-being.

Trial setting, design, and methods

This is a multi-site study conducted at UK mainstream and special educational needs schools. It is an assessor-blind, pragmatic, randomised controlled trial.

The trial is recruiting 240 children aged 7-11 years with a clinical diagnosis of autism. Participants are randomised to either support as usual plus improvisational music therapy sessions (intervention arm) or support as usual (control arm). Those in the improvisational music therapy group will receive 30-minute individual music therapy sessions twice a week over a 12-week period.

A community engagement panel was recruited to develop the Autism-CHIME study protocol. The panel helped increase the accessibility of study materials and select the final study outcomes. Meetings are held with the community engagement panel bi-annually. When the results of the study are complete, the study team will work with the panel to share the findings in an accessible format.

Trial objectives

The primary objective is to determine whether individual sessions of improvisational music therapy in addition to support as usual is superior to support as usual alone in improving social communication in autistic children. Secondary objectives will also be assessed.

Chief Investigators: Professor Simon Baron-Cohen (Autism Research Centre, University of Cambridge); Dr Carrie Allison (Autism Research Centre, University of Cambridge); Dr Yeshaya David M. Greenberg (CHIME Research, Center for Health Innovation, Music, and Education); Dr Jonathan Pool, Cambridge Institute for Music Therapy Research, ARU
ARCTU involvement: Trial management; database; randomisation service
Trial sponsor and funding: University of Cambridge (sponsor); the Autism Centre of Excellence (ACE) at Cambridge, the Rosetrees Trust, and the Stoneygate Trust (funders); ARU (supporter)
Project reference number: ClincialTrials.gov: NCT06016621