Systemic Autism-related Family Enabling study (SAFE)
Research type
Research Study
Full title
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\n
IRAS ID
213527
Contact name
Rebecca McKenzie
Contact email
Sponsor organisation
Plymouth Hospitals NHS Trust
Duration of Study in the UK
1 years, 2 months, 2 days
Research summary
Autism affects more than 1% of the UK population. Children with autism (CWA) have communication problems and often have challenging behaviour. The families of CWA often have problems with their mental health and may need help to manage the difficulties associated with autism. Family wellbeing and life chances are often poor. The care received by families following diagnosis is currently fairly limited.\nSystemic Autism Family Enabling (SAFE) is a specific therapy for families of CWA. We intend to run a large study to assess its effectiveness, and by running this feasibility study a larger study can be planned and delivered with confidence. \nWe will recruit 36 families of CWA (diagnosed within the last 12 months), 24 will be chosen at random to receive SAFE and 12 will receive usual local support alone. SAFE is a therapy for the whole family and involves five three-hour sessions, three in the family home and two with other families, and a follow-up session for the intervention families. SAFE will use specially trained family therapists incorporating the most effective elements from various approaches, and uses visual materials and play-based approaches to explore aspects of autism, problem-solving, emotional well being and coping strategies. We will ask all 36 families to complete various questionnaires and invite them to talk to us about their experiences of participating in the study.\nSAFE was developed by a professional team with input from autism parent-experts from more than 90 families. Families were involved in the development of SAFE activities to ensure that the needs and outcomes they identified are met. We will continue to involve families in the conduct of this study. We will share our results with policymakers, clinicians and families; in the future we hope the larger study will show that SAFE is effective and can be used across the UK.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
17/SW/0192
Date of REC Opinion
16 Oct 2017
REC opinion
Further Information Favourable Opinion