SAFE 2

A randomised controlled trial to evaluate the effectiveness and cost effectiveness of Systemic Autism-related Family Enabling (SAFE), an intervention for families of autistic children
SAFE study logo

SAFE 2

A randomised controlled trial to evaluate the effectiveness and cost effectiveness of Systemic Autism-related Family Enabling (SAFE), an intervention for families of autistic children
 
 

Live trial status update

The study is open at the following locations: Devon, Central and North West London, Leicestershire, and South London and Maudsley.
SAFE is a study for families of autistic children. The study is being run by a team in Plymouth, funded by the UK’s National Institute for Health and Care Research. Several locations in England are taking part. These are:
  • Devon Partnership NHS Trust
  • Central and North West London NHS Foundation Trust
  • Leicestershire Partnership NHS Trust
  • South London and Maudsley NHS Foundation Trust
  • Greater Manchester Mental Health NHS Foundation Trust
  • East London NHS Foundation Trust

Background

Autism is experienced by about 2% of people in the UK. Autistic children can have problems talking and interacting and are often distressed. This is sometimes called behavioural distress, challenging behaviour or meltdown. Families of autistic children often have problems with mental health too. Families of autistic children can also experience significant stress, particularly when support services do not meet their needs. These families may need help to manage the difficulties the experience. Family wellbeing and life chances of autistic children are poor. Currently, many families report that the care and support available following an autism diagnosis does not adequately reflect their experiences, strengths, or support needs as the care and support received by families once they know their child has autism is not suitable at the moment.

Aims

Systemic Autism-related Family Enabling (SAFE) is a package of support for families of autistic children based on Family Therapy. SAFE includes known ways of helping autistic people. We will carry out a large study to find out whether SAFE is helpful for families. We also want to know if the cost is acceptable to use SAFE in the NHS. We will also find out what would help use of SAFE in the NHS or make it difficult.

Design

Based on what we know worked in our previous research, we will invite 494 families of autistic children from multiple sites (6 or 7) across in the UK to take part. From these families, 329 will be chosen at random to receive SAFE, as well as usual care. Usual care is what families receive from the NHS or local authority. The other families will receive usual care only. SAFE supports the whole family. When taking part in SAFE, families can decide who makes up their family. The autistic child and their main carer must take part. Families can include the autistic child, mums, dads, siblings, grandparents, and step-family members. Families may also include other close people if the families wish.
Taking part in SAFE involves attending two three-hour sessions for parents in a group with other parents of autistic children. There are also five two-hour sessions for each family including children. All sessions take place in community rooms. Families will work with specially trained therapists. SAFE includes useful ideas from Family Therapy and Attachment Theory. SAFE uses discussion, images, and play-based activities to help families understand one another's experiences, strengthen relationships, support wellbeing, and develop helpful ways of coping with challenges. All 494 families will be asked to complete questionnaires before and after receiving SAFE or usual care. The final questionnaires will be completed one year after families are randomly allocated to a study group. We will explore changes in communication, family relationships, coping, strengths, and wellbeing. We will also invite some families to share their experiences of taking part in the study through group discussions.

Family involvement

SAFE was developed with more than 90 families of autistic children. These families worked alongside a team of psychologists and therapists. Their experiences, knowledge, and ideas helped to guide every stage of SAFE's development. Families have helped to write funding bids to make sure the study looks at their needs. Families have also helped to make sure finding out about SAFE is about answers to their problems. One of the researchers on the study team is a parent of an autistic child and leads a group of parents and autistic people who provide advice and feedback. We will continue to work closely with this group throughout the study to ensure family and autistic voices remain at the heart of the project.

Sharing results

We will share what we have found out about whether SAFE is helpful with people who change policy, NHS workers, therapists, families and other groups. We will also share what we have found out about using SAFE across the UK. We will use a range of accessible ways to share our findings, including local and national events, online meetings, newsletters, and community networks. By sharing what we learn, we hope to support future services and improve access to approaches that are important to autistic children and their families.
 

The team

 
This study/project is funded by the NIHR Health Technology Assessment Programme (NIHR167788). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.