Department of Physical Therapy, Faculty of Rehabilitation Medicine, University of Alberta, University of Alberta, 3-60 Corbett Hall, Edmonton, AB, T6G 2G4, Canada.
Department of Occupational Therapy, Faculty of Rehabilitation Medicine, University of Alberta, 3-20 Corbett Hall, Edmonton, AB, T6G 2G4, Canada.
BMC Pediatr. 2022 Jun 29;22(1):375. doi: 10.1186/s12887-022-03381-4.
Child-oriented goal-setting in pediatric rehabilitation may improve child motivation, engagement in therapy, child outcomes related to therapy, and service delivery efficiency. The primary objective of this trial is to determine the effectiveness of a principles-driven, child-focused approach to goal-setting, Enhancing Child Engagement in Goal-Setting (ENGAGE), on pediatric rehabilitation outcomes compared to usual practice. The three secondary objectives are to 1) compare costs and secondary outcomes of the ENGAGE approach to usual practice, 2) determine the influence of child, parent and therapist characteristics on child engagement in therapy and rehabilitation outcomes, and 3) identify barriers and facilitators to the implementation of ENGAGE.
This research protocol describes a pragmatic, multi-site, cluster, effectiveness-implementation (hybrid type 1 design) randomized controlled trial. Therapists (n = 12 clusters of two therapists) at participating sites (n = 6) will be randomized to 1) the ENGAGE intervention group, or 2) usual care (control) using a computer-generated, permuted-block randomization sequence with site as a stratification variable designed by a statistician (RR). Each therapist will recruit four children 5-12 years old with neurodevelopmental conditions (n = 96), who will receive ENGAGE or usual care, according to therapist group allocation. ENGAGE therapists will be trained to use a 'toolbox' of evidence-driven, theory-informed principles to optimize child and parent motivation, engagement in the goal-setting process, and performance feedback strategies. Outcomes include goal performance (primary outcome), engagement in therapy, functional abilities, participation, and parent and child quality of life. Qualitative interviews with children, parents, ENGAGE therapists, and managers will explore challenges to implementation and potential mitigation strategies. Mixed effects multiple linear regression models will be developed for each outcome to assess group differences adjusted for clustering. A cost-effectiveness analysis will combine cost and a measure of effectiveness into an incremental cost-effectiveness ratio. Qualitative data on implementation will be analyzed inductively (thematic analysis) and deductively using established implementation science frameworks.
This study will evaluate the effects of collaborative goal-setting in pediatric rehabilitation and inform effective implementation of child-focused goal-setting practices.
NCT05017363 (registered August 23, 2021 on ClinicalTrials.gov).
以儿童为导向的目标设定在儿科康复中可能会提高儿童的动机、参与治疗、与治疗相关的儿童结果以及服务提供效率。本试验的主要目的是确定一种以原则为导向、以儿童为中心的目标设定方法（增强儿童参与目标设定，简称 ENGAGE）在儿科康复结果方面与常规实践相比的有效性。三个次要目标是：1）比较 ENGAGE 方法与常规实践的成本和次要结果；2）确定儿童、家长和治疗师的特征对儿童参与治疗和康复结果的影响；3）确定实施 ENGAGE 的障碍和促进因素。
本研究方案描述了一项实用的、多地点、群组、有效性-实施（混合 1 型设计）随机对照试验。参与地点的治疗师（n=12 个治疗师群组，每个群组有 2 名治疗师）将随机分为 1）ENGAGE 干预组，或 2）使用由统计学家设计的、基于计算机生成的、置换块随机分组序列（按地点分层变量）的常规护理（对照组）（RR）。每位治疗师将招募 4 名 5-12 岁患有神经发育障碍的儿童（n=96），根据治疗师组分配，这些儿童将接受 ENGAGE 或常规护理。ENGAGE 治疗师将接受培训，以使用证据驱动、理论指导的原则工具包来优化儿童和家长的动机、参与目标设定过程以及绩效反馈策略。结果包括目标表现（主要结果）、治疗参与度、功能能力、参与度以及家长和儿童的生活质量。对儿童、家长、ENGAGE 治疗师和管理人员进行定性访谈，以探讨实施的挑战和潜在的缓解策略。将针对聚类调整组间差异，为每个结果制定混合效应多线性回归模型。成本效益分析将结合成本和有效性措施，得出增量成本效益比。将对实施的定性数据进行归纳分析（主题分析）和使用既定实施科学框架进行演绎分析。
本研究将评估协作式目标设定在儿科康复中的效果，并为以儿童为中心的目标设定实践的有效实施提供信息。
NCT05017363（于 2021 年 8 月 23 日在 ClinicalTrials.gov 上注册）。
