Title: A pragmatic Randomised Controlled Trial of Sensory Integration Therapy versus usual care for sensory processing difficulties in Autism Spectrum Disorder in children: impact on behavioural difficulties, adaptive skills and socialisation (SenITA)
Funder: Health and Care Research Wales (Welsh Government)

Abstract: Design: 2-arm RCT of Sensory Integration Therapy (SIT) for children with ASD and Sensory Processing (SP) difficulties. Setting: Participants recruited from CAMHS/paediatrics, schools, support/social services, self-referral. Therapy delivered in clinics meeting fidelity criteria. Population: Children with ASD and SP difficulties. Inclusion criteria: ASD/related disorder; in mainstream primary education for the duration of the trial (4-11 yrs); definite/probable SP difficulties (SPM); carer consent/child assent. Exclusions: current/previous SIT; current Applied Behaviour Analysis therapy. Health technology: SIT (Ayres Sensory Integration® in 26 1-hr sessions (2 per wk for 10 wks, 2 per month for 2m, 1 per month for 2m. 10% fidelity-assessed). Current care pathway: The comparator is usual care (UC) 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 provision of UC. Costs and outcomes (baseline, 6 & 12m): The primary outcome is irritability/agitation at 6 months (ABC-I[5]). Secondary outcomes are: other problem behaviour (ABC subscales); adaptive behaviours, socialisation (VABS-II); functional change (PEDI-CAT); carer stress (APSI) and QoL (EQ5D; CarerQol). Analyses will be linear regression intention to treat adjusted for stratification factors (accounting for therapist clustering). Non-adherence will be investigated (Complier-Average Causal Effect). Subgroup analyses include region, age, confirmed ASD diagnosis, severity of SP difficulties, adaptive behaviour, socialisation, comorbid conditions. Mediation analyses will explore whether an effect at 12m is mediated via SP post-intervention (SPM). A cost-effectiveness evaluation will assess intervention, NHS, social and education service and carer costs (CSRI). The main cost-effectiveness measure is incremental cost per point improvement in ABC-I (6m). An internal pilot with progression criteria will assess: recruitment, retention and whether UC differs from expected provision. A process evaluation will examine contamination, fidelity of intervention delivery, adherence and any adverse effects. Therapist and carer interviews will explore: barriers/facilitators, adherence, therapeutic relationship, mechanisms of change, SP deficit, engagement in activities and contamination. Interview and focus group data will be double-coded and analysed using thematic analysis. Sample size: 216 participants randomised 1:1 based on 90% power, 5% significance level and a moderate standardised effect size of 0.5 (inflated by 20% for dropout/contamination). Online randomisation will utilise random permuted blocks stratified by region and severity of SP difficulty. Project timetable: Ethics/governance approvals m1-4; recruitment/baseline m4-24 (approximately 12.5 p/m across both arms); intervention delivery m4-30; 6m follow-up m10-30; 12m follow-up m16-36; interviews m24-33; analysis m34-38; reporting/dissemination m36-39. Expertise: The multidisciplinary team covers expertise in: occupational therapy, SIT, ASD, development/evaluation of complex interventions, trials in vulnerable populations, statistics, health economics, qualitative research and process evaluation. The trial will be fully coordinated by CTR. The Wales Autism Research Centre has agreed to act as a collaborator to support participant identification.

Lay abstract: Autism Spectrum Disorder (ASD) is a common lifelong condition affecting 1 in 100 people. ASD affects how a person relates to others and the world around them. Difficulty responding to sensory information (noise, touch, movement, taste, sight) is common in ASD. This might include feeling overwhelmed or distressed by loud or constant low-level noise e.g. in the classroom. Affected children may also show little or no response to these sensory cues. These ‘sensory processing difficulties’ are associated with behaviour and socialisation problems, and affect education, relationships, and participation in daily life. Sensory Integration Therapy (SIT) is a type of face-to-face therapy or treatment, provided by trained occupational therapists. The therapist uses play-based sensory-motor activities to influence the way the child responds to sensation, reducing distress and improving concentration and interaction with others. Research suggests SIT might be helpful for some children. In this study we are interested in whether, compared to treatment normally offered to families (‘usual care’), SIT improves the child’s behaviour, socialisation and daily functioning. Usual care could involve some contact with an occupational therapist, who might give parents strategies to practice at home with their child. It is much less common though to be offered the kind of structured one-to-one regular contact involved in SIT (26 face-to-face sessions over 26 weeks in this study). We will compare SIT to usual care in a sample of 216 children and will assess behaviour, daily functioning, socialisation, and parent/carer stress at 6 and 12 months using questionnaires. Those who agree to take part will be allocated at random (i.e. by chance) to either SIT or usual care by an online programme. We will organise discussion groups for therapists and carers before approaching people to take part, so that we can map out what people normally receive as ‘usual care’. Carers will be given diaries (paper-based or electronic) to record their contact with NHS and other services (e.g. social care). We are also interested in carers’ views of their experience in the study and of their child’s sensory problems. We will interview a sample of carers at 6 months. We will also interview therapists to get a sense of what intervention was actually provided to people in the study. We will assess the cost of providing this type of treatment, compared to usual care. Once approximately 10% of study participants have completed the 6-month assessment, we will look at a sample of carer diaries to see whether SIT is different (in content or amount of contact) to usual care. The study will only continue if this is confirmed. We will also look at the number of people willing to take part and whether they continue to participate in all sessions and assessments. We have discussed this proposal with a parent of a child with sensory processing difficulties and currently receiving SIT. We will also involve volunteers from the National Autistic Society (NAS) and Cerebra in planning our research. We will organise an event for affected families to publicise the results and make a summary available to organisations like NAS to include on their websites. A summary will also be made available via social media.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH