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Managing patients at home eases pressure on wards and reduces patient anxiety, finds Jacqui Thornton

New clinical trials are being suspended to prioritise covid-19 studies and enable the redeployment of clinical staff to frontline care, the National Institute for Health Research (NIHR) has said. Louise Wood, co-lead for the NIHR, said setting up of new Clinical Research Network (CRN) studies or new sites of ongoing studies would be "paused" so complete focus could be given to delivering research into covid-19. 1 Trials in the recruitment stage may also be halted, with NHS trusts and health boards making decisions on a case by case basis. One of the trials halted at University College London Hospital NHS Foundation Trust is the ROSCO breast cancer trial examining two tests to guide chemotherapy before surgery for invasive breast cancer. 2 An NIHR spokesperson said, "Local research and clinical teams will work with patients to minimise impact, especially for patients on interventional trials." Studies will continue if halting them will have "significant detrimental effects" on the ongoing care of participants-for example, when there is no other treatment. Around 200 new trials are typically added to the CRN portfolio each month.

BackgroundAutism 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, and 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 face-to-face therapy or treatment provided by trained occupational therapists who use play-based sensory-motor activities and the just-right challenge to influence the way the child responds to sensation, reducing distress, and improving motor skills, adaptive responses, concentration, and interaction with others. With limited research into SIT, this protocol describes in detail how the intervention will be defined and evaluated.MethodsThis is a two-arm pragmatic individually 1:1 randomised controlled trial with an internal pilot of SIT versus usual care for primary school aged children (aged 4 to 11 years) with ASD and sensory processing difficulties; 216 children will be recruited from multiple sources. Therapy will be delivered in clinics meeting full fidelity criteria for manualised SIT over 26 weeks (face-to-face sessions: two per week for 10 weeks, two per month for 2 months; telephone call: one per month for 2 months). Follow-up assessments will be completed at 6 and 12 months post-randomisation. Prior to recruitment, therapists will be invited to participate in focus groups/interviews to explore what is delivered as usual care in trial regions; carers will be invited to complete an online survey to map out their experience of services. Following recruitment, carers will be given diaries to record their contact with services. Following intervention, carer and therapist interviews will be completed.DiscussionResults of this trial will provide high-quality evidence on the clinical and cost effectiveness of SIT aimed at improving behavioural, functional, social, educational, and well-being outcomes for children and well-being outcomes for carers and families.Trial registrationISRCTN14716440. Registered on 8 November 2016.Electronic supplementary materialThe online version of this article (10.1186/s13063-019-3205-y) contains supplementary material, which is available to authorized users.

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