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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 11
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Anglia Ruskin University
RECRUITING
Cambridge
Autism Research Centre
RECRUITING
Cambridge
Contact Information
Primary
Simon Baron-Cohen, Professor
sb205@cam.ac.uk
01223 465215
Backup
Artur Jaschke, PhD
aj723@cam.ac.uk
Time Frame
Start Date: 2023-11-13
Estimated Completion Date: 2025-12
Participants
Target number of participants: 240
Treatments
No_intervention: Support as usual control Group
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
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.
Related Therapeutic Areas
Sponsors
Collaborators: Musical Universe, Anglia Ruskin University, Rosetrees Trust, Stoneygate Trust, Autism Centre of Excellence
Leads: Prof Simon Baron-Cohen

This content was sourced from clinicaltrials.gov