Childhood autism Mental and Behavioural Disorders
Conditions
Interventions
The trial design is a cluster randomised controlled trial with an internal pilot comparing the Social Story™ intervention with care as usual. Trial participants are 4-11-year-old primary school childr
Sponsors
Leeds and York Partnership NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
4 Years to 11 Years
Inclusion criteria
Inclusion criteria: 1. Aged 4-11 years 2. Attends a school in Yorkshire and Humber 3. Has a research diagnostic criteria diagnosis of ASD and daily challenging behaviour
Exclusion criteria
Exclusion criteria: 1. The school has used Social Stories™ for the child in the current or preceding school term 2. The child or interventionist teacher has taken part in the ASSSIST feasibility study. The study will not exclude schools that have taken part
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Child social responsiveness measured using the Social Responsiveness Scale, Second Edition (SRS-2) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Challenging behaviours measured using a bespoke goal-based outcome measure (validated with blinded observation of 20% of participants in a classroom setting by research assistants at 6 weeks and at 6 months) at 6 months 2. Social and emotional health measured using Revised Children Anxiety and Depression Scale (RCADS) short form at 6 months 3. Cost-effectiveness of Social Stories™ measured using a bespoke resource use questionnaire at 6 months 4. Health-related quality of life measured using a bespoke health care resource use questionnaire and EQ-5D-Y proxy at 6 months 5. Parental stress levels measured using Parental Stress Index (PSI) short form at 6 months 6. Classroom attendance and out of area placements measured using a bespoke questionnaire to determine current school care/education plan interventions and support provided to the child in class at 6 months 7. Sustainability of Social Stories™ measured using a bespoke Social Stories™ sustainability questionnaire at 6 months 8. Treatment preference measured using a bespoke preference questionnaire prior to randomisation at baseline 9. Session delivery measured using a bespoke Social Stories™ session log capturing frequency, length and times; problems or adverse events in the context of delivery at 6 weeks | — |
Countries
England, United Kingdom
Outcome results
None listed