Randell Elizabeth, McNamara Rachel, Delport Sue, Busse Monica, Hastings Richard P, Gillespie David, Williams-Thomas Rhys, Brookes-Howell Lucy, Romeo Renee, Boadu Janet, Ahuja Alka S, McKigney Anne Marie, Knapp Martin, Smith Kathryn, Thornton Jacqui, Warren Gemma
Centre for Trials Research, Cardiff University, 4th floor Neuadd Meirionnydd, Heath Park, Cardiff, UK.
School of Healthcare Sciences, Cardiff University, Ty Dewi Sant, Heath Park, Cardiff, UK.
Trials. 2019 Feb 11;20(1):113. doi: 10.1186/s13063-019-3205-y.
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, 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.
This 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.
Results 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.
ISRCTN14716440 . Registered on 8 November 2016.
自闭症谱系障碍（ASD）是一种常见的终身疾病，每100人中就有1人受其影响。ASD会影响一个人与他人及周围世界的互动方式。对感官信息（噪音、触摸、运动、味觉、视觉）做出反应存在困难很常见，可能包括被响亮或持续的低水平噪音（如在教室里）弄得不知所措或痛苦不堪。受影响的儿童对这些感官线索也可能几乎没有反应或完全没有反应。这些“感官处理困难”与行为和社交问题相关，并影响教育、人际关系及日常生活参与。感觉统合疗法（SIT）是一种由训练有素的职业治疗师提供的面对面治疗方法，他们通过基于游戏的感觉运动活动和恰到好处的挑战来影响儿童对感觉的反应方式，减轻痛苦，并提高运动技能、适应性反应、注意力以及与他人的互动能力。由于对SIT的研究有限，本方案详细描述了如何定义和评估该干预措施。
这是一项双臂实用型个体1:1随机对照试验，对患有ASD和感官处理困难的小学年龄儿童（4至11岁）进行SIT与常规护理的内部试点研究；将从多个来源招募216名儿童。治疗将在符合SIT手册化完全保真标准的诊所进行，为期26周（面对面治疗：每周两次，共10周，每月两次，共2个月；电话随访：每月一次，共2个月）。随机分组后6个月和12个月将完成随访评估。在招募之前，将邀请治疗师参加焦点小组/访谈，以探索试验地区常规护理的内容；将邀请照顾者完成一项在线调查，以了解他们的服务体验。招募后，将给照顾者发放日记，记录他们与服务机构的接触情况。干预后，将完成对照顾者和治疗师的访谈。
本试验的结果将为SIT的临床和成本效益提供高质量证据，旨在改善儿童的行为、功能、社交、教育和幸福感，以及照顾者和家庭的幸福感。
ISRCTN14716440。于2016年11月8日注册。
