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临床试验/NCT07056387
NCT07056387进行中(未招募)不适用

The Effects of a Nurse-led Community-based Sailing Programme on Resilience of School-aged Children With Autism: A Randomised Controlled Trial

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2025年7月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
184
试验地点
1
主要终点
Resilience

研究概览

简要总结

The goal of this randomised controlled trial is to evaluate the effect of a nurse-led community-based sailing programme on resilience of school-aged children with autism in inclusive education.

Does intervention improve the resilience of participants? Does intervention improve the quality of life, self-esteem, depressive symptoms, and social functioning outcomes of participants?

Researchers will compare the effect of intervention (community-based sailing programme) to the attention control group (Crafting activities) at baseline, post-intervention, and at 3-month and 9-month follow-ups.

Participants will:

Participants in the intervention group will participate in a nurse-led community-based sailing programme over six days, with each day consisting of 4 sessions, each lasting an hour, for a total of 24 hours.

Participants in the attention control group will engage in crafting activities with minimal difficulty, focusing on maintaining attention without any emotional or reflective discussions.

详细描述

Autism spectrum disorder (ASD) is a neurodevelopmental condition that typically emerges in early childhood, characterized by persistent deficits in social communication and interaction, with the presence of restricted, repetitive patterns of behaviour, interests, or activities. This study seeks to address the outcome gap in the literature, the resilience of children with ASD, and contribute to their holistic health through integrating nature and the community.

The study hypothesizes that, compared to the attention control group, school-aged children with ASD in inclusive education who participate in the intervention group will exhibit: (1) increased levels of resilience, (2) improved quality of life (QoL), (3) reduced depressive symptoms, (4) enhanced self-esteem, and (5) improved social functioning, both immediately post-intervention and at 3-month and 9-month follow-ups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

The study employs single masking, where only the outcome assessor is blinded. Due to the nature of the interventions, masking the participants and intervention providers is not feasible.

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Be between the ages of 7 and 12,
  • •Have a confirmed diagnosis of ASD,
  • •Be enrolled in an inclusive education school,
  • •Possess the ability to complete the questionnaire in Chinese,
  • •Be able to communicate in Chinese.

排除标准

  • •With sailing experience,
  • •With a history of severe motion sickness symptoms.

研究组 & 干预措施

Attention controlled Group

Active Comparator

The attention control group participates in crafting activities (e.g., making handicrafts or painting) to engage participants in an active process, allowing for a comparison of the intervention's effects (sailing programme) against an alternative active activity.

干预措施: Crafting activities (Other)

Intervention group

Experimental

Eligible participants will participate in the nurse-led CBS programme, utilising dinghies with a universal design known for their exceptional stability to prioritize safety. The concrete experience will be introduced through sailing activities. The instructor-to-participant ratio will be 1:6 with a safety boat present.

干预措施: A nurse-led community-based sailing programme (Other)

结局指标

主要结局

Resilience

时间窗: Pre-intervention, Post-intervention (within 1 week immediately after intervention), and at 3-month and 9-month follow-ups.

Resilience will be measured using the 14-item Resilience Scale (RS-14), which assesses personal competence, self-acceptance, and life acceptance. Each item is rated on a 7-point Likert scale (1 = "strongly disagree" to 7 = "strongly agree"), with total scores ranging from 14 to 98. Higher scores indicate greater resilience. The validated Chinese version of the RS-14, with a Cronbach's alpha of 0.86, has demonstrated good internal consistency for assessing resilience in young adolescents in Hong Kong.

Resilience

时间窗: Pre-intervention, Post-intervention (within 1 week immediately after intervention), and at 3-month and 9-month follow-ups.

Resilience will be measured using the 14-item Resilience Scale (RS-14), which assesses personal competence, self-acceptance, and life acceptance. Each item is rated on a 7-point Likert scale (1 = "strongly disagree" to 7 = "strongly agree"), with total scores ranging from 14 to 98. Higher scores indicate greater resilience. The validated Chinese version of the RS-14, with a Cronbach's alpha of 0.86, has demonstrated good internal consistency for assessing resilience in young adolescents in Hong Kong.

次要结局

  • Depressive symptoms(Pre-intervention, Post-intervention (within 1 week immediately after intervention), and at 3-month and 9-month follow-ups.)
  • Self-esteem(Pre-intervention, Post-intervention (within 1 week immediately after intervention), and at 3-month and 9-month follow-ups.)
  • Quality of life (QoL)(Pre-intervention, Post-intervention (within 1 week immediately after intervention), and at 3-month and 9-month follow-ups.)
  • Social functioning outcomes(Pre-intervention, Post-intervention (within 1 week immediately after intervention), and at 3-month and 9-month follow-ups.)
  • Depressive symptoms(Pre-intervention, Post-intervention (within 1 week immediately after intervention), and at 3-month and 9-month follow-ups.)
  • Self-esteem(Pre-intervention, Post-intervention (within 1 week immediately after intervention), and at 3-month and 9-month follow-ups.)
  • Quality of life (QoL)(Pre-intervention, Post-intervention (within 1 week immediately after intervention), and at 3-month and 9-month follow-ups.)
  • Social functioning outcomes(Pre-intervention, Post-intervention (within 1 week immediately after intervention), and at 3-month and 9-month follow-ups.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Myrian Sze Nga Fan

PhD Candidate

Chinese University of Hong Kong

研究点 (1)

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