ISRCTN83964946
Completed
N/A
A multi-centred, randomised, controlled feasibility study comparing the SAFE intervention with support as usual for families of children with autism spectrum disorder. Systemic Autism-related Family Enabling (SAFE) study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Specialty: Mental health, Primary sub-specialty: Developmental disorders - Autism
- Sponsor
- Plymouth Hospitals NHS Trust
- Enrollment
- 36
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
2020 protocol in https://pubmed.ncbi.nlm.nih.gov/31133577 (added 11/05/2020) 2020 results in https://pubmed.ncbi.nlm.nih.gov/33384385/ (added 11/01/2021)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Family includes child with ASD, aged 3\-16 years
- •2\. Diagnosis of ASD, severity level 1 or 2
- •3\. Diagnosed within 12 months of consenting to the study
- •4\. If other diagnoses are present, ASD must be primary diagnosis
- •5\. Family are willing to comply with study requirements
Exclusion Criteria
- •1\. Children with ASD severity level 3
- •2\. Children with ASD and intellectual impairment
- •3\. Serious concomitant illness in child or family, or other circumstances such that they are unable to comply with study requirements
- •4\. Families who may be a risk to safety of research staff
- •5\. Insufficient English language, or capacity for parent/child to consent/assent to the study
Outcomes
Primary Outcomes
Not specified
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