Majnemer Annette, O'Donnell Maureen, Ogourtsova Tatiana, Kasaai Bahar, Ballantyne Marilyn, Cohen Eyal, Collet Jean-Paul, Dewan Tammie, Elsabbagh Mayada, Hanlon-Dearman Ana, Filliter Jillian Helen, Lach Lucyna, McElroy Theresa, McGrath Patrick, McKellin William, Miller Anton, Patel Hema, Rempel Gina, Shevell Michael, Wittmeier Kristy
Faculty of Medicine, School of Physical and Occupational Therapy, McGill University, Montreal, QC, Canada.
Montreal Children's Hospital, Research Institute of the McGill University Health Center, Montreal, QC, Canada.
Front Pediatr. 2019 Aug 7;7:332. doi: 10.3389/fped.2019.00332. eCollection 2019.
In preschool-aged children with, or at elevated risk for, developmental disabilities, challenges and needs arise from vulnerabilities linked to critical and newly emerging cognitive, speech, motor, behavioral, and social skills. For families, this can be a stressful period as they witness the gradual unfolding of their child's differences and await to receive care. Nationally and internationally, service delivery models during this critical period are not standardized nor are they nimble or sufficient enough, leading to long wait times, service gaps and duplications. Given these struggles, there is a need to examine whether "health coaching", a structured educational program that is deliverable by different and more accessible means, can be effective in empowering families, by delivering information, providing social supports, and decreasing the demands on the overwhelmed health and developmental services. The primary objective is to evaluate the feasibility and the effectiveness of a coaching intervention (in comparison to usual and locally available care), for parents of children with emerging developmental delays. A multi-centered pragmatic randomized controlled trial design will be used. Families will be recruited from a representative sample of those awaiting publicly-funded regional child health services for children with developmental delays in four Canadian provinces. The target sample size is 392 families with children aged 1.5 to 4.5 years at recruitment date. Families will be randomly assigned to receive either the BRIGHT Coaching intervention (coach supported, hardcopy and online self-managed educational resources: 14 sessions, 2 sessions every 4 weeks for 6-9 months) or usual care that is locally available. In addition to the feasibility and acceptability measures, outcomes related to family empowerment, parental satisfaction and efficacy with caregiver competency will be evaluated at baseline, post-treatment (8 months), and follow-up (12 months). This manuscript presents the background information, design, description of the interventions and of the protocol for the randomized controlled trial on the effectiveness of BRIGHT Coaching intervention for families of children with emerging developmental delays. ClinicalTrials.gov, U.S. National Library of Medicine, National Institutes of Health #NCT03880383, 03/15/2019. Retrospectively registered.
对于患有发育障碍或有发育障碍高危风险的学龄前儿童而言，与关键及新出现的认知、语言、运动、行为和社交技能相关的脆弱性会带来各种挑战和需求。对家庭来说，这可能是一个压力巨大的时期，因为他们目睹着孩子的差异逐渐显现，并等待着接受治疗。在国内和国际上，这一关键时期的服务提供模式既不规范，也不够灵活或充分，导致等待时间过长、服务缺口和重复现象。鉴于这些困难，有必要研究 “健康指导”——一种可通过不同且更易获得的方式提供的结构化教育项目——是否能通过提供信息、给予社会支持以及减轻不堪重负的健康和发育服务需求来有效地增强家庭的能力。主要目标是评估针对发育迟缓初现的儿童家长的指导干预措施（与常规及当地可得护理相比）的可行性和有效性。将采用多中心实用随机对照试验设计。将从加拿大四个省份中等待为发育迟缓儿童提供公共资助的区域儿童健康服务的代表性样本中招募家庭。目标样本量为招募时孩子年龄在1.5至4.5岁之间的392个家庭。家庭将被随机分配接受BRIGHT指导干预（由教练支持、提供纸质版和在线自我管理教育资源：共14次课程，每4周2次课程，为期6至9个月）或当地可得的常规护理。除了可行性和可接受性措施外，还将在基线、治疗后（8个月）和随访（12个月）时评估与家庭赋权、家长满意度以及照顾者能力效能相关的结果。本手稿介绍了关于BRIGHT指导干预对发育迟缓初现的儿童家庭有效性的随机对照试验的背景信息、设计、干预措施描述及方案。ClinicalTrials.gov，美国国立医学图书馆，美国国立卫生研究院 #NCT03880383，2019年3月15日。追溯注册。
