Systemic Autism-related Family Enabling (SAFE) study
| ISRCTN | ISRCTN83964946 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83964946 |
| Integrated Research Application System (IRAS) | 213527 |
| Protocol serial number | 34613, IRAS 213527 |
| Sponsor | Plymouth Hospitals NHS Trust |
| Funders | Autistica, National Institute for Health Research |
- Submission date
- 20/11/2017
- Registration date
- 20/11/2017
- Last edited
- 11/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Autism is a lifelong disorder that affects how people communicate and relate to others and to the world. Autism affects more than 1% of the UK population. Children with autism (CWA) have communication problems and often have challenging behaviour. The families of CWA often have problems with their mental health and may 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. Systemic Autism Family Enabling (SAFE) is a specific therapy for families of CWA. SAFE is a therapy for the whole family and involves five three-hour sessions, three in the family home and two with other families, and a follow-up session for the intervention families. SAFE uses specially trained family therapists incorporating the most effective elements from various approaches, and uses visual materials and play-based approaches to explore aspects of autism, problem-solving, emotional wellbeing and coping strategies. SAFE was developed by a professional team with input from autism parent-experts from more than 90 families. Families are involved in the development of SAFE activities to ensure that the needs and outcomes they identified are met. Families are involved in the conduct of this study throughout. The results will be shared with policymakers, clinicians and families and in the future it is hoped that a larger study will show that SAFE is effective and can be used across the UK. The aim of this study is to assess the effectiveness of the SAFE therapy, and by running this feasibility study a larger study can be planned and delivered with confidence.
Who can participate?
Families that include a child who have been diagnosed with Autism aged three to 16 years old.
What does the study involve?
Participating families are randomly allocated to one of two groups. Those in the first group receive their usual support. Those in the second group receive the SAFE therapy. 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. Families are asked to complete various questionnaires and some are invited to talk to in depth about their experiences of participating in the study.
What are the possible benefits and risks of participating?
The SAFE family therapy sessions will involve discussing difficulties and may evoke emotions and stressful feelings. The therapists undertaking SAFE will be available to discuss any thoughts and feelings that participants have in between sessions and at the start of each session. There is a slight chance that the SAFE family therapy sessions could lead to an initial increase in family disagreements as family members learn how to change the way they solve problems and talk with one another. The SAFE study team includes trained therapists who are supervised by an experienced clinical psychologist, so appropriate support will be available to help with any difficulties that may arise.
Where is the study run from?
1. Plymouth University (UK)
2. Child Development Centre Scott Business Park (UK)
3. Childrens Care Management Centre (UK)
4. Royal Cornwall Hospitals NHS Trust (UK)
When is the study starting and how long is it expected to run for?
June 2017 to May 2019
Who is funding the study?
1. Autistica
2. National Institute for Health Research
Who is the main contact?
Sarah Campbell
Contact information
Public
Senior Trials Manager
Peninsula Clinical Trials Unit
Plymouth University
N16
ITTC Building 1
Plymouth Science Park
Plymouth
PL6 8BX
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Treatment, Psychological & Behavioural, Complex Intervention |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A multi-centred, randomised, controlled feasibility study comparing the SAFE intervention with support as usual for families of children with autism spectrum disorder. Systemic Autism-related Family Enabling (SAFE) study |
| Study acronym | SAFE |
| Study objectives | The overarching aim of this study is to establish the feasibility of a definitive randomised controlled trial of Systemic Autism-related Family Enabling (SAFE) therapy for families of children with autism (CWA). |
| Ethics approval(s) | South West - Exeter Research Ethics Committee, 16/10/2017, ref: 17/SW/0192 |
| Health condition(s) or problem(s) studied | Specialty: Mental health, Primary sub-specialty: Developmental disorders - Autism; UKCRC code/ Disease: Mental Health/ Disorders of psychological development |
| Intervention | The SAFE intervention is an intensive programme of systemic family therapy designed to treat Autism Spectrum Disorder (ASD) and mental health related difficulties encountered by families of children with autism (CWA). Each therapy session includes two therapists. Between weeks one and 16, families allocated to the SAFE intervention attend five three hour SAFE therapy sessions. Sessions 1 and 5 are multi-family sessions and take place in a community setting with appropriate insurance for the activities undertaken. Children, including the CWA do not need to be present at these sessions. Where group sessions are not possible, for example if one family is not available on a given date, group sessions may be replaced with home visits. Sessions 2, 3 and 4 takes place in the family home. The minimum number of family members that need to be present for a home session to take place is one parent and the child with autism. Where home visits are not possible, for example where there is a resident sick relative, home visits may be replaced with sessions in a community setting. The therapists facilitate sessions which will be video recorded, as is usual practice for therapy sessions. The videotapes (and transcribed excerpts of the footage) are not part of the reported study data, they are only be used by the therapists in supervision sessions, in preparation for subsequent sessions, therapy process research and for training. The videotapes are kept in a locked cupboard at Plymouth University by the therapist supervisor. Appointments are arranged at times to suit the participant families, and visit reminders are sent out to participants as appropriate. Where families do not attend or cancel sessions, these will be rescheduled. To encourage compliance with the programme, families are given 16 weeks to complete all therapy sessions. All sessions, whether completed or missed, are tracked and recorded within the study database. Following completion of the therapy programme, families attend a group follow-up session at 24 weeks post-allocation. Trained support workers from local voluntary groups attend this follow-up session and are invited to give the families information about continued support for families of CWA through existing networks. Each session includes the following assessments are given to families to complete: 1. Client Satisfaction Questionnaire (CSQ-8) 2. The Helpful Aspects of Therapy Questionnaire (HAT) A Between Session Activity (BSA) homework activity is given to families after each session. Families are given a pro-forma with key elements of the intervention as prompts. Families track strengths and difficulties in response to SAFE ideas. Families bring the completed activity to the following session. Therapists respond to the activity in the session and reflect on it in relation to the intervention process during supervision. Families are expected to spend at least 30 minutes every fortnight completing this activity. In addition, there will be email or telephone conversation between therapists and family (“check-in time”) in order to provide reassurance, collect feedback and plan home visits. At the end of each session the therapist will complete a training checklist and questionnaire (TCQ). Participants in both study arms are followed up at 32 weeks |
| Intervention type | Other |
| Primary outcome measure(s) |
Global family function is measured using the SCORE 15 questionnaire at baseline and 32 week follow up. |
| Key secondary outcome measure(s) |
1. Child behaviour is measured using the Child Behaviour Checklist (CBCL) questionnaire at baseline and 32 week follow up |
| Completion date | 30/05/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 36 |
| Key inclusion criteria | 1. Family includes child with ASD, aged 3-16 years 2. Diagnosis of ASD, severity level 1 or 2 3. Diagnosed within 12 months of consenting to the study 4. If other diagnoses are present, ASD must be primary diagnosis 5. Family are willing to comply with study requirements |
| Key exclusion criteria | 1. Children with ASD severity level 3 2. Children with ASD and intellectual impairment 3. Serious concomitant illness in child or family, or other circumstances such that they are unable to comply with study requirements 4. Families who may be a risk to safety of research staff 5. Insufficient English language, or capacity for parent/child to consent/assent to the study |
| Date of first enrolment | 01/01/2018 |
| Date of final enrolment | 03/09/2018 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
ITTC Building 1
Plymouth Science Park
Plymouth
PL6 8BX
United Kingdom
Plymouth
PL2 2PQ
United Kingdom
Truro Health Park
Infirmary Hill
Truro
TR1 2JA
United Kingdom
Cornwall
Truro
TR1 3LJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 31/12/2020 | 11/01/2021 | Yes | No |
| Protocol article | protocol | 27/05/2019 | 11/05/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
11/01/2021: Publication reference added.
11/05/2020: The following changes have been made:
1. Publication reference added.
2. The IRAS number has been added.
20/03/2019: Study contact updated.
16/10/2018: The recruitment end date was changed from 03/09/2018 to 30/09/2018
09/08/2018: The recruitment end date was changed from 30/06/2018 to 30/09/2018
