Title: A study to establish the feasibility of a definitive randomised controlled trial evaluating SAFE, an intervention for families of children with autism
Funder: Department of Health and Social Care

Abstract: Background. More than 1% of the UK population has a diagnosis of autism and numbers are rising. Children with autism (CWA) have impairments in social interaction, communication and behavioural flexibility. In addition, families of CWA present complex needs. Autism is widely believed to have a genetic component and the Broad Autism Phenotype is disproportionately represented among family members. Mental health problems are experienced by more than 70% of individuals with autism and over 50% of their parents. Individuals with autism suffer from high levels of anxiety and depression compared to those with other developmental conditions. Similarly, families of CWA have higher rates of depression, anxiety and social phobia, than families with typically developing children, or children with other developmental disorders. Mothers have higher levels of unmet needs, more difficulty coping, and lower levels of satisfaction with service interactions than mothers of children with other disabilities. Because the families display psychological needs alongside autism, even conservative estimates of the costs of providing services to meet them exceed &pound;4 billion p.a. Families of CWA are a high risk group, but their treatment tends to be disjointed, costly, and inadequate. Working with more than 90 families as well as other therapy experts we have developed SAFE (Systemic Autism-related Family Enrichment), a systemic family therapy which addresses autism related needs, including mental health difficulties and problematic behaviour. SAFE not only addresses needs expressed by families, but also directly responds to the recommendations of NICE guidelines, the proposals of the Munroe Report, and the Future in Mind children and young people s mental health report. Aims. To be confident that SAFE is an effective and cost-effective intervention for families of CWA, we intend to conduct a large multi-centre trial. Before we can do so, there are important uncertainties we need to address. The present proposal, therefore, is for a feasibility study which, if successful, will lead quickly on to our larger, national trial. This feasibility study will allow us to assess: our ability to identify, recruit and randomise families; the acceptability of our research methods to families; their adherence to the intervention; our ability to collect resource use data; whether our training arrangements are feasible and scalable. In addition qualitative work will guide us on the conduct of the larger trial as well as the SAFE intervention itself. Plan. We shall recruit 36 families of children aged 0 &ndash; 16 with a diagnosis of autism spectrum disorder from two centres in the South West. They will be randomised to SAFE plus treatment as usual (TAU) or to TAU alone in a ratio of 2:1 (SAFE plus TAU:TAU only). Those allocated to SAFE will be invited to attend five fortnightly three hour sessions plus a follow-up at six months in which the whole family participates. The first and final sessions plus the 'follow up' will be held in community settings with other families in the study whilst sessions 2,3, and 4 will be conducted with a single family in their own home. Families will be assessed both before randomisation and after treatment. A range of outcome measures will be used, but our primary outcome will be the Systemic CORE 40 (SCORE). We shall also be collecting economic data and qualitative information through semi-structured interviews and focus groups. Potential benefits. This study and the subsequent multi-centre RCT provide opportunities to develop current practice and policy to meet existing guidelines and initiatives, as well as addressing the urgent needs articulated by families of children with autism. Subject to meeting progression criteria and implementation, the SAFE intervention has the potential to benefit families and the NHS.

Lay abstract: Background: Autism affects more than 1% of the UK population. Children with autism (CWA) have communication problems and often present with challenging behaviour. The families of CWA often have problems with their mental health and 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. Aims: Systemic Autism Family Enrichment (SAFE) is a specific treatment for families of CWA based on established principles. We intend to run a large study to assess its effectiveness, but first we propose a feasibility study to ensure that larger study can be planned and delivered with confidence. Design: We will recruit 36 families of CWA, 24 of which will be chosen randomly to receive SAFE. SAFE is a therapy for the whole family and involves five three-hour sessions, three in the family home and two with other families, plus a follow-up session. SAFE is delivered by specially-trained family therapists and incorporates the most effective elements from various approaches. It uses visual materials and play-based approaches to explore aspects of autism, problem-solving, emotional wellbeing and coping strategies. We will ask all 36 families to complete various questionnaires and invite some of them to talk to us in depth about their experiences of participating in the study. Patient and public involvement: SAFE 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 identified needs and outcomes are met. We will continue to involve families in the conduct of this study. Dissemination: We will share our results with policymakers, clinicians and families; we hope the larger study will show that SAFE is effective and can be used across the UK.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: MENTAL HEALTH