Autism - Children's Improvisational Music Therapy Evaluation

Autism Clinical Trial

— CHIME  

Official title:

A Randomised Controlled Trial on the Effectiveness of Improvisational Music Therapy for Autistic Children Aged 7 - 11 [Autism-CHIME Trial].

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06016621
• Other study ID #: PRE.2022.077
• Secondary ID: ETH2223-3184
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2023
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: University of Cambridge
• Contact: Simon Baron-Cohen, Professor
• Phone: 01223 465215
• Email: sb205[@]cam.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

Behavioral:
• Improvisational Music Therapy
The therapist engages with the child by playing and sharing musical instruments, and/or sings while being attuned to the child's behaviour and expression. Various improvisational techniques are employed to engage the child. There are opportunities for pulse, rhythmic, dynamic or melodic patterns, and timbre to be mirrored, reinforced, or complemented, which allows for moments of synchronization between the therapist and the child, giving the child's musical expressions a pragmatic meaning within this context. The therapist may also gently provoke the child by violating expectations or patterns that have been jointly developed in order to elicit specific social communication behaviours. Further, there are opportunities for the child to develop and enhance social communication skills such as joint attention, sharing affect, reciprocity, shared history, scaffolding, imitation and turn-taking. These have been shown to develop social competency and also resilience.

Locations

Country	Name	City	State
United Kingdom	Anglia Ruskin University	Cambridge
United Kingdom	Autism Research Centre	Cambridge

Sponsors (6)

Lead Sponsor	Collaborator
Prof Simon Baron-Cohen	Anglia Ruskin University, Autism Centre of Excellence, Musical Universe, Rosetrees Trust, Stoneygate Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (53)

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* Note: There are 53 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The BOSCC consists of specific items that were developed to identify changes in social-communication behaviours over relatively short periods of time by quantifying subtleties in both the frequency and the quality of specific behaviours. There are three forms of the BOSCC: one for individuals who are minimally verbal (MV), one for those with phrase speech/young fluent speakers (PS/YF up to age 6 - 8) and one for fluent speakers (F1/F2 with two sets of materials, one for children and one for adolescents and adults). Scores are based on the observation of social communicative behaviour during naturalistic interactions between a child and an adult.	Baseline and at the end of intervention (13 weeks after randomisation).
Secondary	Absolute change of the total score of the BOSCC.	The BOSCC consists of specific items that were developed to identify changes in social-communication behaviours.	Baseline and 39 weeks after randomisation.
Secondary	Absolute change of the total score of the Children's Communication Checklist-2 to test improvement in communication skills.	Measure designed to assess the communication skills of children 4 to 16. It includes two domains: Language (Speech, Syntax, Semantics, Coherence) and Pragmatics (Initiation, Scripted Language, Context, Nonverbal Communication, Social Relations, Interests).	Baseline, 13 and 39 weeks after randomisation.
Secondary	Absolute change of the total score of the Strengths and Difficulties Questionnaire to test improvement in psychosocial difficulties	Questionnaire of behavioural and emotional difficulties suitable for children aged 3-16 years old. It addresses different dimensions: emotional problems, conduct problems, hyperactivity/inattention problems, peer problems and prosocial behaviour.	Baseline, 13 and 39 weeks after randomisation.
Secondary	Absolute change of the total score of the Young Child Outcome Rating Scale (YCORS) as a measure of wellbeing.	Engaging young children regarding their assessment of how they are doing using child friendly language (faces).	Baseline, 13 and 39 weeks after randomisation.
Secondary	Absolute change of the total score of the Vineland-3 Domain level parent/caregiver form to test improvement in adaptive functioning.	Measure of adaptive functioning including Communication domain, Daily living skills domain and Socialization domain.	Baseline, 13 and 39 weeks after randomisation.
Secondary	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.	The PRAS-ASD is a 25-item, parent-reported measure of anxiety symptoms in youth with ASD (age 5-17 years).	Baseline, 13 and 39 weeks after randomisation.
Secondary	Association between the therapeutic relationship and the development of social, communication and language skills.	The therapeutic relationship will be measured using the Assessment of the Quality of Relationship (AQR), based on video recordings of the first and last of music therapy to evaluate the association between the therapeutic relationship and the development of social, communication and language skills in children allocated to the music therapy intervention.	Weeks 1 and 12
Secondary	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.	Measured based on video recordings of the first and last weeks of music therapy in all of the children allocated to the music therapy intervention) to evaluate communicative and socially interactive responses that are elicited during music therapy sessions.	Weeks 1 and 12.