Not yet recruitingInterventional

The SAFE study: Exploring a new support package for autistic children and their families

The SAFE study is testing a new support programme for families with autistic children aged 3-16. Autism affects around 2% of people in the UK, and families often face difficulties. The SAFE programme was created with families and uses talking, images, and play to help manage challenges like "meltdowns." The study wants to find out if SAFE improves families' emotional well-being and coping skills more than the usual care they receive. It also checks if the programme is practical and affordable for the NHS. Two-thirds of families will get the SAFE programme plus usual care, while one-third will only get usual care. Your child's autism must be their main diagnosis to take part.

At a glance

Status

Not yet recruiting

Sponsor

Devon Partnership NHS Trust

Enrolment target

494

Start

01 Aug 2026

Estimated completion

31 Mar 2028

Diagnosis of autism; if other diagnoses are present (e.g., ADHD, OCD, ED), autism must be the primary diagnosis

What is this study about?

Autism affects about 1 in 50 people in the UK. Children with autism often find communication and social situations tricky, and may get very upset or stressed, which can be hard for the whole family. Support for families after an autism diagnosis isn't always enough or just right for their needs. To help with this, a new support programme called SAFE has been developed together with families of autistic children. The SAFE programme uses tried-and-tested methods to help families handle challenges that can come with autism, like what some people call "meltdowns." It's designed to support everyone in the family.

SAFE sessions are run by trained therapists and involve talking, using pictures, and playing to look at autism-related challenges, behaviour, how everyone is feeling, and ways to cope. The programme includes two group sessions for parents and five individual sessions where your family meets with a therapist. These seven sessions take place over about 20 weeks. This study wants to find out if taking part in the SAFE programme helps families feel better emotionally and cope more effectively than families who receive just the usual care from the NHS or local council.

We also want to see if SAFE is practical to deliver and if it offers good value for money for the NHS. If this study shows that SAFE is helpful and affordable, it could mean that more families across the UK could benefit from this type of support in the future.

Key takeaways

The SAFE study is testing a new family support programme for autistic children (3-16 years old).
It aims to improve family mental health and coping, and assess if SAFE is feasible for the NHS.
Two-thirds of families will get the SAFE programme, one-third will get usual care.
Involves group parent sessions and individual family sessions over about 20 weeks.
Participation helps future families of autistic children and is considered low risk.

Who may be eligible?

To join the study, your family needs to have a child aged between 3 and 16 years old who has been diagnosed with autism. If your child also has other conditions like ADHD, OCD, an eating disorder, or epilepsy, their autism must be the main health condition they're dealing with.

Families won't be able to join if there are serious health issues in the child or family that would make it hard to take part, or if there's a risk to the research team. Also, if your family is already getting a similar type of family therapy, or if you can't understand or communicate in English (because the SAFE programme is delivered in English), you won't be able to take part. However, if English is an additional language for your family, you can bring someone to help you understand and communicate during appointments.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have a child aged between 3 and 16 years old?
Has your child received an autism diagnosis?
Is your child's autism their main health condition if they have others?
Are you able and willing to attend appointments and complete questionnaires in English?
Are you not currently receiving another family therapy programme?

Answer every question to see your result.

What does participation involve?

If you decide to take part, all families will first have a meeting with a study researcher. During this meeting, we'll check if the study is right for your family, you'll fill out some questionnaires, and take part in a fun Lego activity. After this, your family will be randomly chosen to be in one of two groups.

Two out of three families will receive the SAFE support programme alongside the usual care you would get. The SAFE programme involves two three-hour group meetings for parents, and five two-hour individual sessions for your whole family, including your child. These sessions will be held in local community rooms with specially trained therapists. The remaining one-third of families will receive only the usual care they would normally get.

All families will have follow-up meetings with our researchers at 5 months and 12 months after the initial selection. At these meetings, you'll complete the same questionnaires and do the same Lego activity again. Some families might also be asked to share their experiences of the study in group discussions. The whole process, including sessions and follow-ups, will take about 12 months.

Potential risks and benefits

By taking part, your family will help us discover if the SAFE programme is truly effective compared to usual care and if it's a good investment for the NHS. If SAFE proves beneficial and cost-effective, it could become more widely available to families in the future. Families who receive the SAFE programme during the study might directly benefit from learning new ways to help their family cope with the challenges of autism. Being in feedback groups could also offer a chance for parents to connect and share experiences with others in similar situations. This is considered a low-risk study. While discussing difficulties in SAFE sessions might bring up strong feelings, our trained therapists are there to provide support before, during, and between sessions. There's a small chance of temporary family disagreements as you explore new ways of communicating, but the goal is to equip families with better problem-solving skills, and therapists will help manage any arising issues. You are free to withdraw from the study at any time.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Prestwich Hospital
Unverified
Manchester, England
Kingsway Hospital (headquarters)
Unverified
Derby, England
Wonford House Hospital
Unverified
Exeter, England
North East London NHS Foundation Trust
Unverified
Rainham, England
Leicestershire Partnership NHS Trust
Unverified
Leicester, England
Central and North West London NHS Foundation Trust
Unverified
London, England

Common questions

What is 'usual care'?

Usual care is the standard support you would normally receive from your local NHS or council services.

How long will the SAFE programme sessions last?

There are two 3-hour group sessions for parents and five 2-hour individual family sessions, taking about 20 weeks in total.

Can my child with autism and ADHD participate?

Yes, as long as autism is the main diagnosis for your child, they can still be considered for the study.

Who is paying for this study?

The study is funded by the National Institute for Health and Care Research (NIHR) in the UK.

What if English isn't my first language?

You can still take part, but we encourage you to bring someone who can help you understand and communicate during appointments.

How to find out more

Kayle-Anne Sands

safe2.penctu@plymouth.ac.uk - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.