Chien Chi-Wen, Lai Yuen Yi Cynthia, Lin Chung-Ying, Graham Fiona
Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong SAR, China.
Institute of Allied Health Sciences, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
Front Pediatr. 2021 Nov 5;9:720885. doi: 10.3389/fped.2021.720885. eCollection 2021.
High rates of restricted community participation have been reported in young children with developmental disabilities. Occupational performance coaching (OPC), grounded in self-determination theory, aims to facilitate children's participation in life situations through coaching parents. However, there have been limited randomized controlled trials demonstrating the efficacy of OPC, especially with a specific focus on children's community participation. The proposed study is the first step in evaluating the feasibility and acceptability of conducting a pilot randomized controlled trial of OPC in Hong Kong and testing its initial efficacy (in comparison to parent consultation) in promoting children's community participation. A feasibility and pilot double-blind randomized controlled trial will be undertaken. Fifty children aged 6 years or below with developmental disabilities and their parents will be recruited from early intervention centers and/or through social media in Hong Kong. Parents will be randomly assigned to receive OPC or consultation, and will be blinded to group allocation. Outcomes will be assessed by blinded assessors at baseline, pre-intervention, post-intervention, and follow-up. Predetermined success criteria will be used to assess the feasibility of the trial. Qualitative interviews will be conducted with parents to explore the acceptability and perceived impact of OPC. This trial will test whether the study protocol and OPC are feasible and acceptable, as well as assess the initial efficacy of OPC to obtain effect size estimates. The results of the trial will inform future preparations for conducting a full-scale efficacy trial of OPC. ClinicalTrials.gov, U.S. National Library of Medicine, National Institutes of Health (#NCT04796909), Registered on 15th March 2021.
据报道，发育障碍幼儿的社区参与受限率很高。基于自我决定理论的职业表现指导（OPC）旨在通过指导家长来促进儿童参与生活情境。然而，证明OPC有效性的随机对照试验有限，尤其是专门针对儿童社区参与的试验。拟议的研究是评估在香港开展OPC试点随机对照试验的可行性和可接受性，并测试其在促进儿童社区参与方面的初步疗效（与家长咨询相比）的第一步。将进行一项可行性和试点双盲随机对照试验。将从香港的早期干预中心和/或通过社交媒体招募50名6岁及以下的发育障碍儿童及其家长。家长将被随机分配接受OPC或咨询，并对分组情况不知情。结果将由不知情的评估人员在基线、干预前、干预后和随访时进行评估。将使用预定的成功标准来评估试验的可行性。将与家长进行定性访谈，以探讨OPC的可接受性和感知影响。 该试验将测试研究方案和OPC是否可行和可接受，并评估OPC的初步疗效以获得效应大小估计。试验结果将为未来开展OPC全面疗效试验的准备工作提供信息。ClinicalTrials.gov，美国国立医学图书馆，美国国立卫生研究院（#NCT04796909），于2021年3月15日注册。
