The SAFE Trial V1.0
Research type
Research Study
Full title
A randomised controlled trial comparing the effectiveness of a therapist-led intervention (SAFE: Systemic Autism-related Family Enabling) plus treatment as usual versus treatment as usual only on global family functioning and mental health in three dimensions (strengths and adaptability, coping with difficulties and problem solving, communication and understanding) in families of autistic children: a multicentre assessor-blinded trial with parallel process evaluation and economic evaluation.
IRAS ID
343024
Contact name
Rebecca Stancer
Contact email
Sponsor organisation
Devon Partnership NHS Trust
ISRCTN Number
ISRCTN89355835
Clinicaltrials.gov Identifier
CPMS, 62076
Duration of Study in the UK
3 years, 11 months, 30 days
Research summary
Background: Autism affects around 2% of people in the UK. Autistic children often struggle with communication and social interaction, and may experience distress or challenging behaviour. This can be hard for families, who often face poor mental health. Support after diagnosis is often not enough or suitable.
A new support programme (called SAFE) has been developed with families of autistic children. SAFE includes proven approaches to help families manage the challenges of autism, such as so-called meltdowns. SAFE supports the whole family. Sessions are led by trained therapists and use talking, images, and play to explore autism-related challenges, behaviour, well-being, and coping.
In the SAFE programme, there are two sessions where all the parents from 8 (+/-2) families meet with the therapists as a group, and five sessions where each family meets with the therapist separately. These seven sessions take about 20 weeks.Aim: This study will test whether SAFE improves family mental health and coping compared to usual care, and whether it is feasible and affordable for the NHS. Usual care is what families receive from the NHS or local authority.
Design and methods: Around 500 families who are in the care of NHS services for autism will take part. The autistic child and their main carer must take part; families can choose who else in their family takes part. Families will be randomly split into two groups: Two thirds of families will receive SAFE plus usual care, and one third will receive usual care only.
All families will complete questionnaires at the beginning and about 5 months later (after the SAFE programme ends) and at 12 months. In this way, we will measure changes in family mental health family strengths, communication and coping. Families will also share their experiences in group discussions with a researcher.REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
26/LO/0247
Date of REC Opinion
30 Apr 2026
REC opinion
Further Information Favourable Opinion