Systemic Autism-related Family Enabling (SAFE) study

Not Applicable

Completed

• Conditions: Specialty: Mental health, Primary sub-specialty: Developmental disorders - Autism; UKCRC code/ Disease: Mental Health/ Disorders of psychological development; Mental and Behavioural Disorders; Autism

• Registration Number: ISRCTN83964946
• Lead Sponsor: Plymouth Hospitals NHS Trust

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-20
• Study Completion: 2019-05-30
• Last Update Posted: 25 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Global family function is measured using the SCORE 15 questionnaire at baseline and 32 week follow up.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Child behaviour is measured using the Child Behaviour Checklist (CBCL) questionnaire at baseline and 32 week follow up<br> 2. Child-parent attachment is measured using the Coding of Attachment-Related Parenting for use with children with Autism (CARP-A) assessment at baseline and 32 week follow up<br> 3. Anxiety & depression is measured using the Patient Health Questionnaire (PHQ-SADS) at baseline and 32 week follow up<br> 4. Reflective Functioning is measured using the reflective functioning questionnaire (RFQ) at baseline and 32 week follow up<br> 5. Caregiving Helplessness is measured using the Caregiving Helplessness Questionnaire (CGHQ) at baseline and32 week follow up<br> 6. Economic outcomes (EQ-5D-5L, CHU-9D, and resource use questionnaires) are measured at baseline and 32 week follow up<br>