A trial of sensory integration therapy versus usual care for sensory processing difficulties in autism spectrum disorder in children

INTERVENTION: Following screening, consent and collection of baseline data, participants will be randomly allocated to usual care or SIT in a 1:1 ratio. Online randomisation will utilise random permuted blocks stratified by region and severity of sensory processing difficulty. Intervention arm: Participants will receive 24 one‐hour sessions of SIT (Ayres Sensory Integration® Therapy) and 2 follow up phone calls, delivered over 26 weeks: two sessions per week for 10 weeks (intensive phase), followed by two sessions per month for two months, then one phone call per month for two months (tailoring phase). The intervention will be delivered by occupational therapists (typically NHS Band 7) trained in SIT meeting fidelity criteria. Comparator arm: Participants will receive usual care (UC) which is defined as awaiting services or sensory based intervention not meeting SIT fidelity criteria (e.g. 1 face‐to‐face session per week or less). Focus groups will map the provision of UC. Follow up assessments will take place at 6 and 12 months post randomisation. CONDITION: Autism Spectrum Disorder in children aged 4‐11 years with sensory processing difficulties. ; Mental and Behavioural Disorders ; Autism spectrum disorder PRIMARY OUTCOME: Irritability/agitation is measured using the Aberrant Behaviour Checklist (ABC) at baseline, 6 and 12 months. SECONDARY OUTCOME: 1. Other problem behaviour is measured using Aberrant Behaviour Checklist (ABC) subscales at baseline, 6 and 12 months; 2. Adaptive behaviours and socialisation are measured using Vineland Adaptive Behavior Scales (VABS‐II) at baseline, 6 and 12 months; 3. Functional change is assessed using the Pediatric Evaluation of Disability Inventory ‐ computer adaptive test (PEDI‐CAT) at baseline, 6 and 12 months; 4. Carer stress is measured using the Autism Parenting Stress Index (APSI) at baseline, 6 and 12 months; 5. Quality of life is measured using the EQ5D and CarerQoL questionnaires at baseline, 6 and 12 months INCLUSION CRITERIA: 1. Children aged between 4 and 11 years with ASD/related disorder 2. In mainstream primary education for the duration of the trial 3. Definite/probable SP difficulties 4. Carer consent/child assent