Autism - Children's Improvisational Music Therapy Evaluation

The goal of this clinical trial is to evaluate the effectiveness of individual sessions of improvisational music therapy for autistic children aged 7 - 11.

Researchers will compare the impact of adding improvisational music therapy to usual care alone for autistic children over a 12-week period.

Participants will be randomly assigned to one of the following two conditions: the Improvisational Music Therapy (intervention) Group or the support as usual (control) Group.

The aim is to achieve seven overarching objectives:

1. To determine whether 12 weeks of 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.
2. To examine whether 12 weeks of individual sessions of improvisational music therapy in addition to support as usual is superior to support as usual alone in improving communication skills in autistic children.
3. To examine whether 12 weeks of individual sessions of improvisational music therapy in addition to support as usual is superior to support as usual alone in reducing psychosocial problems in autistic children.
4. To examine whether 12 weeks of individual sessions of improvisational music therapy in addition to support as usual is superior to support as usual alone in improving wellbeing of autistic children.
5. To examine whether 12 weeks of individual sessions of improvisational music therapy in addition to support as usual is superior to support as usual alone in improving adaptive functioning in autistic children.
6. To examine whether 12 weeks of individual sessions of improvisational music therapy in addition to support as usual is superior to support as usual alone in improving anxiety in autistic children.
7. To examine whether the therapeutic relationship predicts the development of social, communication and language skills among autistic children.

Co-Chief Investigators Professor Simon Baron-Cohen Dr Carrie Allison Dr David M. Greenberg Dr. Jonathan Pool

Co-Investigators Dr Artur Jaschke

Advisor Emeritus Professor Helen Odell-Miller Dr. Claire Howlin

The Autism-CHIME trial is designed as a rigorous Randomised Controlled Trial (RCT) of individual sessions of improvisational music therapy with autistic children. The trial will be conducted in mainstream and special schools located in Cambridgeshire, Peterborough, London, and the South and East of England. The number of schools involved will depend on the number of eligible children willing to participate, with a minimum of 5-10 children per school.

Enrolled participants will undergo 1:1 block randomisation, to either support as usual plus improvisational music therapy sessions (intervention arm) or support as usual (control arm). Randomisation will occur after the baseline assessments have been completed. Participants will be stratified based on the version of the Brief Observation of Social Communication Change (BOSCC) that they are allocated (primary outcome measure): (1) Minimally Verbal, (2) Phrase Speakers, or (3) Fluent Speakers, so that there are equal numbers in each group, and that the control group and experimental group are balanced.

Data will be collected at different time points during the trial:

The first data collection point (T1) will be collected prior to randomisation (to establish eligibility to participate and assess baseline functioning), and at the primary endpoint T2 (13 weeks after randomisation; end of intervention) and the secondary endpoint T3 will be 39 weeks post-randomisation (i.e. 6 months after the end of music therapy).

The trial will finish after the final follow-up data collection from the participants is completed.

Eligibility Criteria:
Inclusion Criteria:

* Aged 7 to 11 years.
* A clinical diagnosis of autism made by a qualified professional according to the International Classification of Diseases (ICD) 10th Revision criteria. Confirmed by a copy of the clinical report detailing the diagnosis (if available) or verified verbally by the child's parents.
* Parents/guardians must give informed consent for their children to be enrolled in the trial.
* Parents/guardians must be willing for the music therapy sessions and BOSCC assessments to be video recorded for monitoring and research purpose
* Participants must be willing to attend two music therapy sessions per week for the duration of the trial.
* Non-verbal children may be included

Exclusion Criteria:

* Received regular individual music therapy in the preceding year as this would be likely to have a strong influence on the course of therapy.
* Severe hearing deficit as this would alter the aim, course, and implementation of therapy.
* Caregivers that are unable to attend for the psychological assessments with their child.
* Caregivers without a basic understanding of English.