Autism - Children's Improvisational Music Therapy Evaluation (CHIME)

Prof Simon Baron-Cohen

Status: Enrolling

Conditions: Autism

Treatments: Behavioral: Improvisational Music Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06016621

ETH2223-3184 (Other Identifier)

PRE.2022.077

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 7 to 11 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups

Support as usual control Group

No Intervention group

Description:

Participants allocated to 'support as usual' will receive routine support from their general practitioners (GPs), mental health and education/allied health professionals. Support as usual is defined as normal practice for each school in addition to the usual support from the specialist teaching teams for autism in the area, or any other additional therapies intended to support communication skills or wellbeing for autistic children. They will not receive the individual music therapy intervention or any extra support services from the research team. Any concomitant treatment or therapeutic interventions that participating children might receive will be recorded during assessment sessions before randomisation, and following the primary endpoint, specifying the kind and amount or frequency of intervention.

Improvisational Music Therapy

Experimental group

Description:

Participating children randomised to the Improvisational Music Therapy (intervention) Group will receive 30-minute individual music therapy sessions two times per week over a 12-week period. These will be delivered by academically trained Health and Care Professions Council (HCPC)-registered music therapists in the United Kingdom (master's level or equivalent) with clinical experience of working with autistic children. Each child in the intervention arm will receive 24 sessions of music therapy over a 12-week period. A music therapy training manual will be used to guide music therapists.

Treatment:

Behavioral: Improvisational Music Therapy