NCT06016621Recruiting
Autism - Children's Improvisational Music Therapy Evaluation
A Randomised Controlled Trial on the Effectiveness of Improvisational Music Therapy for Autistic Children Aged 7 - 11 [Autism-CHIME Trial].
Source: ClinicalTrials.gov · Last updated 25 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 19 Aug 2023
- Start date
- 13 Nov 2023
- Primary completion date
- Dec 2025
- Lead sponsor
- Prof Simon Baron-Cohen
- Diseases
- Autism
- NCT number
- NCT06016621
What you commit to
- Study type: Interventional
- Planned participants: 240
- From 13 Nov 2023 to the primary completion date, Dec 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- Caregivers that are unable to attend for the psychological assessments with their child.
- Caregivers without a basic understanding of English.
Who the study is looking for
- 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
Age in the registry: 7 years to 11 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Autism Research Centre Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Recruiting |
| Anglia Ruskin University Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.