Autism - Children's Improvisational Music Therapy Evaluation

NCT06016621 | Recruiting

• 2 other identifiers: PRE.2022.077ETH2223-3184
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

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. 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. 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. 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. 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. 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. 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. 7.To examine whether the therapeutic relationship predicts the development of social, communication and language skills among autistic children.

Conditions

Autism

Keywords

Randomised Controlled Trial; Improvisational music therapy; Autism; Children; Social communication; Social cognition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Absolute change of the total score of the BOSCC.

  Baseline and 39 weeks after randomisation.

• Absolute change of the total score of the Children's Communication Checklist-2 to test improvement in communication skills.

  Baseline, 13 and 39 weeks after randomisation.

• Absolute change of the total score of the Strengths and Difficulties Questionnaire to test improvement in psychosocial difficulties

  Baseline, 13 and 39 weeks after randomisation.

• Absolute change of the total score of the Young Child Outcome Rating Scale (YCORS) as a measure of wellbeing.

  Baseline, 13 and 39 weeks after randomisation.

• Absolute change of the total score of the Vineland-3 Domain level parent/caregiver form to test improvement in adaptive functioning.

  Baseline, 13 and 39 weeks after randomisation.

Study Arms (2)

Support as usual control Group

NO INTERVENTION

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

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.

Behavioral: Improvisational Music Therapy

Interventions

Improvisational Music Therapy BEHAVIORAL

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.

Improvisational Music Therapy

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prof Simon Baron-Cohen: lead
• Anglia Ruskin University: collaborator
• Musical Universe: collaborator
• Rosetrees Trust: collaborator
• Stoneygate Trust: collaborator
• Autism Centre of Excellence: collaborator

Study Sites (2)

Anglia Ruskin University

Cambridge, CB1 1PT, United Kingdom

RECRUITING

Autism Research Centre

Cambridge, CB2 8AH, United Kingdom

RECRUITING

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MeSH Terms

Conditions

Autistic Disorder; Communication

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavior

Study Officials

• Jonathan Pool, PhD

  Cambridge Institute for Music Therapy Research. Anglia Ruskin University, Cambridge

  PRINCIPAL INVESTIGATOR

• David M. David M. Greenberg, PhD

  Musical Universe Inc. USA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Baron-Cohen, Professor

CONTACT

01223 465215; sb205@cam.ac.uk

Artur Jaschke, PhD

CONTACT

aj723@cam.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research assistants involved in data collection will be blinded to treatment allocation for the entire duration of the study. Success of blinding will be verified by asking assessors if they inadvertently found out about the treatment allocation - instances of unblinding will be recorded using a case report form with details including information on who was unblinded, the source of the unblinding and the reason for the unblinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Simon Baron-Cohen

Model Details: 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.

Study Record Dates

• First Submitted: August 19, 2023
• First Posted: August 29, 2023
• Study Start: November 13, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)