Music therapy for children with autism (Version 1.0)
Research type
Research Study
Full title
Trial of Improvisational Music Therapy’s Effectiveness for Children with Autism (TIME-A): UK Arm of the Time-A study.
IRAS ID
140752
Contact name
Mike Crawford
Contact email
Sponsor organisation
Imperial College London
ISRCTN Number
ISRCTN78923965
Research summary
This application is for a UK arm of the ‘TIME-A’ study, a multi-centre international clinical trial of music therapy for children with Autism Spectrum Disorder (ASD). The study is led by a team of researchers in Norway and is being conducted in nine other countries. The TIME-A study is a three-arm, parallel group, researcher-blind, randomised trial of music therapy plus enhanced treatment as usual for children aged from 4:0 to 6:11 years old, who have ASD.
Music Therapy is a form of psychosocial intervention that harnesses the power of music to provide an alternative means to learn about and develop communication skills and relationships through active co-improvisation between children and therapists. Parents of all children in the study will receive usual care plus three sessions of parent counselling (at 0, 2, and 5 months). In addition, children randomised to the two intervention arms of the study will be offered individual, improvisational music therapy over a five month period, either one session (low-intensity) or three sessions (high-intensity) per week. Study participants will have an equal chance of being allocated each of these three conditions.
Study outcomes will be assessed two, five and 12 months after randomisation. The primary outcome is the severity of autism symptoms assessed using the Autism Diagnostic Observation Schedule. The main secondary outcomes are parent-rated social responsiveness, parenting stress and parental well-being.
The sample size calculation for the international trial showed that 300 patients would be needed to have 90% power to detect a medium effect size of the intervention on the Autism Diagnostic Observation Schedule at 5 months with a 5% level of statistical significance. In order to ensure that the international trial achieves this, we have been asked to recruit 100 patients in the UK.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
14/WM/1047
Date of REC Opinion
8 Jul 2014
REC opinion
Further Information Favourable Opinion