Autism spectrum disorders Mental and Behavioural Disorders Autism
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Autism Diagnostic Observation Schedule (ADOS) Social Affect score at 5 months | — |
Secondary
| Measure | Time 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