Diagnosis of autism
Conditions
Interventions
CHOICE OF STUDY DESIGN AND METHODOLOGY
This study has been informed by a successful feasibility randomised controlled trial. The study has been designed to compare the effectiveness of intervention ag
Sponsors
Devon Partnership NHS Trust
Eligibility
Sex/Gender
All
Age
3 Years to 65 Years
Inclusion criteria
Inclusion criteria: Families must satisfy all the following criteria to be enrolled in the study: 1. Family includes autistic child, aged 3-16 years*. 2. Diagnosis of autism, severity level 1 or 2 (in accordance with DSM-5). 3. If other diagnoses are present (e.g., ADHD, OCD, ED), autism must be the primary diagnosis. 4. Family are willing and able to comply with study requirements. *In families with more than one eligible child, only one can be the family index case.
Exclusion criteria
Exclusion criteria: Families who meet any of the following criteria will be excluded from study participation: 1. Serious concomitant illness in the child or family, or other circumstances affecting compliance with study requirements. 2. Risk to the safety of research staff*. 3. Family currently or due to take part in family therapy-based intervention during study participation. 4. Individual family members already taking part in the SAFE trial as part of another family unit. 5. Unable to understand or communicate in English**. *Examples of risk: Violent behaviour causing injury that requires treatment, or a family member who has a serious infectious disease. **English language: This is due to the delivery of the SAFE intervention being in English. Those who speak English as an additional language will be eligible to take part, but will be encouraged to attend appointments with a conversational partner if necessary to assist with study delivery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Family functioning and caregiver mental health measured using the Systemic CORE-15 (SCORE-15) total score at at baseline and at 22 weeks post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Health-related quality of life and quality-adjusted life years (QALYs) for child participants measured using QALYs derived from the Child Health Utility 9 Dimensions (CHU-9D) at baseline, 22 and 52 weeks post-randomisation, with proxy completion by the primary caregiver for children aged 5 to 6 years and the CHU-9D proxy version for children under 5 years of age;Capability wellbeing and years of full capability (YFCs) measured using YFCs derived from the ICEpop CAPability measure for Adults (ICECAP-A) at baseline, 22 and 52 weeks post-randomisation;Health, social care and wider societal resource use measured using a bespoke Resource Use Questionnaire informed by previous RUQs and co-developed with the PPI group at at baseline, 22 and 52 weeks post-randomisation;Family functioning measured using the Systemic CORE-15 (SCORE-15) total score at baseline and at 52 weeks post-randomisation;Family functioning strengths and adaptability measured using the strengths and adaptability dimension score of the Systemic CORE-15 (SCORE-15) at baseline, 22 and 52 weeks post-randomisation;Family functioning coping with difficulties and problem solving measured using the coping with difficulties and problem-solving dimension score of the Systemic CORE-15 (SCORE-15) at baseline, 22 and 52 weeks post-randomisation;Family functioning communication and understanding measured using the communication and understanding dimension score of the Systemic CORE-15 (SCORE-15) at baseline, 22 and 52 weeks post-randomisation;Family functioning from the child perspective for children aged 7 years or older measured using the Child Systemic CORE-15 (Child SCORE-15) total score at baseline, 22 and 52 weeks post-randomisation;Child-reported family strengths and adaptability for children aged 7 years or older measured using the strengths and adaptability dimension score of the Child Systemic CORE-15 (Child SCORE-15) at baseline, 22 and 52 weeks post-randomisation;Child-reported coping with difficulties and | — |
Countries
England, United Kingdom
Contacts
Public ContactKayle-Anne Sands
Outcome results
None listed