Autism - Children's Improvisational Music Therapy Evaluation

Study Overview
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Brief Summary
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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: 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. 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. 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. 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. 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. 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. To examine whether the therapeutic relationship predicts the development of social, communication and language skills among autistic children.

Detailed Description
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Co-Chief Investigators Professor Simon Baron-Cohen Dr Carrie Allison Dr David M. Greenberg Dr. Jonathan Pool Co-Investigators Dr. Claire Howlin Advisor Emeritus Professor Helen Odell-Miller 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.

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

Conditions
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Autism

Intervention / Treatment
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* Behavioral: Improvisational Music Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Assessor-blind, multi-centre, pragmatic, two-arm, randomised controlled trial in which participants will be randomly allocated to either: Twice-weekly 30 minute-sessions of one to one improvisational music therapy over 12 weeks, in addition to support as usual. Support as usual control group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Support as usual control Group<br>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. | |
| Experimental: Improvisational Music Therapy<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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 | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomised Controlled Trial, Improvisational music therapy, Autism, Children, Social communication, Social cognition