Clinical trial NCT06016621: Autism - Children's Improvisational Music Therapy Evaluation
Official title: A Randomised Controlled Trial on the Effectiveness of Improvisational Music Therapy for Autistic Children Aged 7 - 11 [Autism-CHIME Trial].
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism
Keywords: Randomised Controlled Trial
Improvisational music therapy
Autism
Children
Social communication
Social cognition
Lead sponsor: University of Cambridge
Sponsor class: OTHER
Collaborators: name: Anglia Ruskin University
name: Musical Universe
name: Rosetrees Trust
name: Stoneygate Trust
name: Autism Centre of Excellence
First posted: 2023-08-29
Enrollment: 240
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assessor-blind, multi-centre, pragmatic, two-arm, randomised controlled trial in which participants will be randomly allocated to either:

1. Twice-weekly 30 minute-sessions of one to one improvisational music therapy over 12 weeks, in addition to support as usual.
2. Support as usual control group.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

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.

Primary outcomes:
measure: Absolute change of the total score of the Brief Observation of Social Communication Change (BOSCC). One of three versions of the BOSCC will be used depending on the child's level of verbal communication.
timeFrame: Baseline and at the end of intervention (13 weeks after randomisation).
Secondary outcomes:
measure: Absolute change of the total score of the BOSCC.
timeFrame: Baseline and 39 weeks after randomisation.
measure: Absolute change of the total score of the Children's Communication Checklist-2 to test improvement in communication skills.
timeFrame: Baseline, 13 and 39 weeks after randomisation.
measure: Absolute change of the total score of the Strengths and Difficulties Questionnaire to test improvement in psychosocial difficulties
timeFrame: Baseline, 13 and 39 weeks after randomisation.
measure: Absolute change of the total score of the Young Child Outcome Rating Scale (YCORS) as a measure of wellbeing.
timeFrame: Baseline, 13 and 39 weeks after randomisation.
measure: Absolute change of the total score of the Vineland-3 Domain level parent/caregiver form to test improvement in adaptive functioning.
timeFrame: Baseline, 13 and 39 weeks after randomisation.
measure: Absolute change of the total score of the Parent-Rated Anxiety Scale (PRAS) for Youth with Autism Spectrum Disorder (ASD) as a measure of anxiety.
timeFrame: Baseline, 13 and 39 weeks after randomisation.
measure: Association between the therapeutic relationship and the development of social, communication and language skills.
timeFrame: Weeks 1 and 12
measure: Absolute change of the total score of the Music Therapy Communication and Social Interaction Scale (MTCSI) (or Music Engagement Scale, MES) based on video recordings.
timeFrame: Weeks 1 and 12.
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Anglia Ruskin University
city: Cambridge
country: United Kingdom
facility: Autism Research Centre
Study officials:
affiliation: Cambridge Institute for Music Therapy Research. Anglia Ruskin University, Cambridge
name: Jonathan Pool, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Musical Universe Inc. USA
name: David M. David M. Greenberg, PhD
role: PRINCIPAL_INVESTIGATOR
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