A Parent-Coaching Intervention to Promote Community Participation of Young Children With Developmental Disability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Change in Participation-related Goal Performance and Satisfaction
研究概览
简要总结
Participation in community activities allows children to meet friends, learns new skills, fosters independence, and paves the foundation for lifelong health. High rates of community participation restriction have been reported in children with developmental disabilities who are aged six years or below, a critical developmental period.
Occupational Performance Coaching (OPC), grounded in self-determination theory, is aimed to facilitate children's participation in life situations through coaching parents. Studies have shown that OPC is effective to promote children's activity participation. However, there have been limited randomized controlled trials demonstrating the efficacy of OPC, especially with the specific focus on children's community participation.
The investigators propose to evaluate the feasibility and acceptability of conducting a pilot randomized controlled trial of OPC for parents of preschool children with developmental disabilities in Hong Kong, and to test its initial efficacy on promoting children's community participation.
详细描述
Parent coaching emerges as a preferred approach for enhancing performance and participation of children with developmental disabilities (DD), but limited clinical trials examine its effects on community participation. Thus, this study aims to evaluate whether parent coaching, specifically using Occupational Performance Coaching (OPC), enhances community participation among young children with DD.
Young children with DD will be recruited from preschool-rehabilitation services offered by three non-governmental organisations in Hong Kong. Ethics approval has been obtained from the Human Subjects Ethics Sub-committee at The Hong Kong Polytechnic University.
A two-arm parallel, double-blind design will be adopted for the study. Fifty parents of young children with DD will be randomly assigned to the intervention group (i.e., OPC) or the active control group (i.e., parents' consultation). Four assessment points will be scheduled throughout the study: 5-6 weeks before intervention (Time 0), 1-2 weeks before intervention (Time 1), 1-2 weeks after intervention (Time 2), and 8-9 weeks after the intervention (Time 3). Randomisation allocation will be completed at Time 1. Participants and independent outcome assessors will not be informed about the groupings.
Each parent will receive a maximum of eight coaching sessions or consultations. The primary outcome will be children's community participation as assessed through parent-report measures at baseline, pre-intervention, post-intervention, and an 8-week follow-up. Children in both groups will continue to receive their usual care, which may include services such as occupational therapy, physiotherapy, and speech therapy on a weekly/monthly basis, depending on their individual needs.
Independent t-test and chi-square statistics will be used to test for between-group baseline differences. To evaluate the effect of OPC on each outcome measure, repeated-measures analysis of covariance (ANCOVA) by controlling for baseline values per outcome will be used. Post-hoc analyses will be performed when the main effects were significant. Statistical significance is set at p < 0.05. Estimates of effect sizes with 95% confidence intervals will be calculated for each outcome measure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 24 Months 至 83 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the child has a clinical diagnosis of developmental disability (including but not limited to intellectual disability, developmental delay, or autism spectrum disorder) given by pediatricians/psychiatrist
- •the parents are the child's main caregiver who have a long-term parenting role with at least 50% of caregiving responsibilities
- •the parents are able to converse in Chinese
- •the parents desire to improve their child's participation in community activities
排除标准
- •the child has developmental disability combined with physical impairment (e.g., amputation, cerebral palsy, spina bifida)
- •the child has developmental disability combined with sensory impairment (e.g., blindness, deafness)
研究组 & 干预措施
Parent coaching
The parent-coaching intervention consists of up to 8 weekly/fortnightly sessions, and each session will last up to one hour.
干预措施: Occupational Performance coaching (Behavioral)
Parent consultation
The parent consultations are given for up to 8 weekly/fortnightly sessions, and each session may last up to one hour.
干预措施: Parent consultation (Behavioral)
结局指标
主要结局
Change in Participation-related Goal Performance and Satisfaction
时间窗: T0=5-6 weeks before intervention; T1=1-2 weeks before intervention; T2=1-2 weeks after intervention; T3=8-9 weeks after the intervention
Performance and satisfaction scores (1-10) of the Canadian Occupational Performance Measure (COPM). Higher scores mean a better outcome.
Change in Children's Community Participation Frequency and Involvement
时间窗: T0=5-6 weeks before intervention; T1=1-2 weeks before intervention; T2=1-2 weeks after intervention; T3=8-9 weeks after the intervention
Frequency scores (0-7) and involvement scores (1-5) of the community section of the Young Children's Participation and Environment Measure (YC-PEM). Higher scores mean a better outcome.
次要结局
- Change in Parenting Efficacy and Satisfaction(T0=5-6 weeks before intervention; T1=1-2 weeks before intervention; T2=1-2 weeks after intervention; T3=8-9 weeks after the intervention)
- Change in Parents' Negative Emotional States(T0=5-6 weeks before intervention; T1=1-2 weeks before intervention; T2=1-2 weeks after intervention; T3=8-9 weeks after the intervention)
- Change in Children's Psychosocial Health(T0=5-6 weeks before intervention; T1=1-2 weeks before intervention; T2=1-2 weeks after intervention; T3=8-9 weeks after the intervention)