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Clinical Trials/ISRCTN83964946
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

Plymouth Hospitals NHS Trust0 sites36 target enrollmentNovember 20, 2017

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)

Registry
who.int
Start Date
November 20, 2017
End Date
May 30, 2019
Last Updated
5 years ago
Study Type
Interventional
Sex
All

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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