A randomised controlled trial to evaluate the effectiveness and cost effectiveness of SAFE (Systemic Autism-related Family Enabling), an intervention for families of autistic children.
Autistic children and their families in the UK are cycling through crisis care because the standard support they receive is disjointed and ineffective. This trial tests whether a structured family therapy programme called SAFE can reduce the mental health distress and behavioural difficulties that drive those crises. The problem is large: current care often fails to prevent escalation to residential placements, and the annual economic burden to the NHS exceeds £32 billion. If SAFE proves superior to treatment as usual, it would give clinicians a manualised, cost-effective alternative that keeps families together and out of crisis services. The trial randomises 494 families across six UK sites, measuring outcomes at 22 and 52 weeks. A parallel implementation study will identify what it takes to roll the programme out in real-world NHS settings. Success would shift autism care from reactive crisis management to proactive, family-centred support—directly addressing the NICE guideline call for psychosocial interventions delivered by trained professionals.
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Research Question Is the SAFE intervention superior to Treatment As Usual (TAU) in reducing autism-related mental health and behavioral distress among families of autistic children? Background Autistic people display restricted interests and difficulties in socio-communication with high risk of mental health problems, trauma, suicidality and behavioural distress. Autism is disproportionally represented among relatives of autistic children, and autism affects >2.8 million family members. Autism is a life-limiting condition. NICE Quality Standard for Autism [QS512014], NHS Outcomes Framework (2014-15) and NICE guidelines [CG170], call for a ‘person-centred’ approach for ‘people with autism and their families’ recommending psychosocial interventions, delivered by trained professionals. Current care is inappropriate, ineffective and disjointed resulting in crisis, escalation and residential care, contributing to an annual economic burden of > £32B. Aim To conduct a randomised controlled trial (RCT) to compare the effectiveness of SAFE plus Treatment as Usual (SAFE+TAU) with Treatment as Usual (TAU) alone. Objectives 1.Test effectiveness of SAFE in reducing autism-related mental health including distress associated with child behaviour compared with TAU. Test whether any effects on outcomes are reported at 22 weeks and 52 weeks post randomisation. 2. Conduct a 6-month internal pilot focusing on recruitment based on the Red Amber Green model. Progression in the amber zone will allow for remedial recruitment modification. Target for the average rate per site per months includes a 50% reduction for the first three months of site opening. 3. Assess the cost impact, cost-effectiveness and cost–utility of SAFE. 4. Carry out an embedded mixed method process evaluation including: a) A mixed method implementation study based on CFIR framework, theoretically informed by Participatory Action Research and Concept Mapping techniques b) Intervention fidelity measurement c) Qualitative investigation to refine Theory of Change and develop logic model Methods A parallel, multi-centre, randomised controlled trial in six sites across the UK with an internal pilot and embedded mixed methods process evaluation. 494 families of autistic children will be individually randomised 2:1 allocation, between SAFE plus Treatment As Usual (SAFE+TAU) and Treatment As Usual (TAU) only, stratified by recruiting site, after consent. Primary Outcome Measure: The Systemic CORE-15 (SCORE), endorsed by The Association of Family Therapy, and CAMHS Outcome Research Consortium with established reliability and validity as an index of therapeutic change (Primary Caregiver). Secondary Outcome Measures: 1. Child SCORE-15 for children >7 years (Children) 2. Patient Health Questionnaire – Somatic Anxiety Depressive Symptoms (PHQ-SADS) (Adults) 3. Mutuality sub-scale of the Coding of Attachment-Related Parenting for use with autistic children - CARP-A (All) Timeline 48-month project. Set up 9 months; recruitment pilot 6 months, overall recruitment 20 months. Outcome data collected at baseline, 22 weeks and 52 weeks post randomisation. Qualitative data collection at 22 and 52 weeks. Anticipated impact and dissemination Potential to improve autism care and reduce the current economic burden to the NHS. Implementation Study will maximise impact. Dissemination through local, national and international events, publications and presentations.
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