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Trial of improvisational music therapy?'s effectiveness for children with autism

Randomised controlled Trial of Improvisational Music therapy?'s Effectiveness for children with Autism spectrum disorders (TIME-A)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN78923965
Enrollment
300
Registered
2011-08-04
Start date
2011-11-01
Completion date
Unknown
Last updated
2017-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism spectrum disorders Mental and Behavioural Disorders Autism

Interventions

1. Individual improvisational music therapy over a period of 5 months, one session (low-intensity) or three sessions (high-intensity) per week 2. Standard care in all treatment arms: 3 sessions of par

Sponsors

GAMUT - The Grieg Academy Music Therapy Research Centre
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 4 years to 6 years, 11 months 2. With a diagnosis of autism spectrum disorder according to ICD-10 criteria as assessed by a child psychiatrist or clinical psychologist; diagnosis of ASD needs to be reconfirmed in the baseline assessment with children fulfilling diagnostic criteria for ASD on both the Autism Diagnostic Observation Schedule (ADOS) and the Autism Diagnostic Interview-Revised (ADI-R)

Exclusion criteria

Exclusion criteria: 1. Children with serious sensory disorders (blindness, deafness) 2. Children who have had any previous experience of music therapy

Design outcomes

Primary

MeasureTime frame
Autism Diagnostic Observation Schedule (ADOS) Social Affect score at 5 months

Secondary

MeasureTime frame
1. ADOS at 2 and 12 months 2. ADOS subscales: Communication, Reciprocal Social Interaction, Imagination/Creativity, Stereotyped Behaviors and Restricted Interests, at 2, 5, and 12 months 3. Social Responsiveness Scale (SRS) as rated by parents/guardians at 2, 5, and 12 months 4. SRS subscales: Social Awareness (receptive aspects of social behavior), Social Cognition (social information processing), Social Communication (capacity for reciprocal social communication), Social Motivation (social anxiety/avoidance), Autistic Mannerisms (autistic preoccupations and traits) 5. Cost-effectiveness ratios and incremental cost-effectiveness ratios for the different alternatives (Cost will be measured as real resources used in treatment, in terms of personnel hours of work; effectiveness is measured by ADOS) Added 05/06/2017: 6. Ratings of quality of life of the child and of the family as a whole, respectively, at 2, 5 and 12 months 7. Adverse events 8. Binary analysis of proportion of participants who improved on the primary outcome

Countries

Australia, Austria, Brazil, Israel, Italy, Korea, South, Norway, United Kingdom, United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 27, 2026