At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Improvisational Music Therapy (behavioural)
- How long the study runs
- Study runs about 25 months (dates as stated)
- About the drug or intervention
- Improvisational Music Therapy — behavioural: 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.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 7 Years to 11 Years
- Who
- All
- Number of participants
- 240
- Started
- 2023-11-13
- Last checked
- 2025-03
Plain English Summary
What is this study?
- • Testing a new treatment for autism
- • NA - 240 participants
- • The goal of this clinical trial is to evaluate the effectiveness of individual sessions of improvisational music therapy for autistic children aged 7 - 11
Who can take part?
- • Ages 7 Years to 11 Years
- • Diagnosed with autism
Where?
- • Cambridge - Anglia Ruskin University
- • Cambridge - Autism Research Centre
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 7 Years - 11 Years
- Who can join: All genders
What the study is looking for
- ✓Aged 7 to 11 years.
- ✓Parents/guardians must give agreement to take part 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...
- ✓Participants must be willing to attend two music therapy sessions per week for the duration of the trial.
- ✓Non-verbal children may be included
Who cannot take part
- ✗Received regular individual music therapy in the preceding year as this would be likely to have a strong influence...
- ✗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.
See the full criteria
Where Is This Study? (2 UK sites)
Anglia Ruskin University
Cambridge CB1 1PT, United Kingdom
Autism Research Centre
Cambridge CB2 8AH, United Kingdom
How to Get in Touch
Simon Baron-Cohen, Professor
Sponsor contactCONTACT
Artur Jaschke, PhD
Sponsor contactCONTACT