- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06575244
The Effects of a Nurse-led Community-based Sailing Programme on Resilience of School-aged Children With Autism
The Effects of a Nurse-led Community-based Sailing Programme on Resilience of School-aged Children With Autism: A Pilot Randomised Controlled Study
The goal of this pilot RCT is to evaluate the feasibility and acceptability of the community-based sailing program and to assess the preliminary effects before the main RCT, given the literature on sailing for children with ASD has not yet been established.
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 community-based sailing to the attention control group at baseline, following randomisation, and post-intervention
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 expand their natural environment to include nature and the community through nature-based interventions (NBIs).
Considering the limited generalizability of autism research findings among children due to the expanded definition of the autism spectrum in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), which merged previous diagnostic labels into one spectrum, translating knowledge into practice becomes challenging. Therefore, a stratification approach is adopted to examine the resilience (Primary outcomes), along with secondary outcomes, including QoL, depressive symptoms, self-esteem, and social functioning based on synthesis from prior studies. A study conducted revealed that school-aged children with ASD in inclusive education significantly exhibited more depressive symptoms, lower QoL, lower resilience, and lower self-esteem. Where resilience is identified as a significant mediator in the association between depressive symptoms and psychosocial health, highlighting the potential of resilience-focused interventions in enhancing resilience and supporting mental health.
Existing community-based sailing (CBS) programs, led by qualified sailing instructors and provided to individuals regardless of ability to foster social connection and overall well-being in the community, hold potential as promising nature-based, resilience-focused recreational activities that incorporate experiential learning. A qualitative study highlighted the positive experience among school-aged children with ASD in inclusive education, where resilience emerged to be a key aspect. This study highlights a critical gap in that many children do not understand resilience and perceive their sailing experience merely as recreational. Thereafter, the proposed study aims to develop and evaluate a nurse-led CBS program to enhance their resilience by recognising the nursing expertise in interprofessional collaboration within a community-based approach.
The proposed study follows the Medical Research Council (MRC)/ National Institute for Health and Care Research (NIHR) framework for developing and evaluating complex interventions. This study will employ a randomized controlled trial (RCT) with an assessor-blind design, in collaboration with the community-based charity organization Sailability Hong Kong, recruiting 36 children with autism aged 7 to 12 years. Outcome measures at Pre-test (T0) and Post-test (T1) were reported as mean (SD) for intervention and control groups. Bias-corrected Hedges' g effect sizes (95% confidence intervals [CIs]) were used to compare standardized mean differences between groups.
This pilot study aims to assess the feasibility and acceptability and to evaluate the initial effects of the nurse-led CBS programme on the resilience of school-aged children with ASD.
The study hypothesizes that in comparison to the control group with attention controlled group, school-aged children with ASD in inclusive education who participate in the intervention group will exhibit (1) increased levels of resilience, (2) improved QoL, (3) reduced depressive symptoms, (4) enhanced self-esteem, (5) improved social functioning immediately after the intervention.
The innovative aspect of this study lies in utilizing CBS as a therapeutic approach aimed at enhancing the resilience of children with ASD in supporting their mental health. This research is original and innovative, building on previous evidence, including systematic reviews, cross-sectional studies, qualitative studies, and conceptual model development. It seeks to bridge the research gap in resilience.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- The Nethersole School of Nursing, The Chinese University of Hong Kong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- be between the ages of 7 and 12,
- have a confirmed diagnosis of ASD,
- be enrolled in inclusive education school,
- possess the ability to complete the questionnaire in Chinese,
- be able to communicate in Chinese.
Exclusion Criteria:
- With sailing experience,
- With a history of severe motion sickness symptoms.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
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.
The programme will conclude with participants receiving a certificate of participation.
|
A nurse-led community-based sailing programme is validated by an expert panel including professionals from various fields, such as a registered nurse, academia, and qualified sailing instructors, delivered in a group of 6 participants, incorporating experiential learning, with the aid of materials including dinghies with Universal design, safety boats, buoys, buoyancy aids, supplementing with a waterproof sailing booklet.
The intervention is developed and facilitated by a registered nurse (principal investigator).
|
|
Placebo Comparator: Controlled group
Participants in the attention control group will participate in crafting activities.
These activities will match the time and attention dedicated by the intervention group but are designed to have no impact on resilience.
|
Participants in the attention control group will participate in crafting activities.
Activities match the time and attention dedicated by the intervention group.
Activities are designed to have no impact on resilience.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resilience
Time Frame: Pre-intervention, Post-intervention (within 1 week immediately after intervention)
|
The Resilience Scale-14 (RS-14) consists of 14 items assessing personal competence, acceptance of self, and life.
Each item is rated on a 7-point Likert scale, ranging from "strongly disagree" to "strongly agree."
The total possible scores on the RS-14 range from 14 to 98, with higher scores indicating higher levels of resilience.
The Chinese version of the RS-14 has been validated for evaluating the resilience of young adolescents in Hong Kong.
It demonstrates good internal consistency, with a Cronbach's alpha coefficient of 0.86.
|
Pre-intervention, Post-intervention (within 1 week immediately after intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depressive symptoms
Time Frame: Pre-intervention, Post-intervention (within 1 week immediately after intervention)
|
The Chinese version of the Center for Epidemiologic Studies Depression Scale for Children (CES_DC) comprises 20 standardized items designed to assess depressive symptoms in children across three domains: emotional, cognitive, and behavioral-related components of depression.
Participants rate the frequency of each symptom experienced during the previous week on a 4-point Likert scale.
Scores range from 0 to 3 (0 = not at all, 1 = a little, 2 = some, and 3 = a lot) for each item.
The total possible CES-DC scores range from 0 to 60, with higher scores indicating a greater number of symptoms.
A score of 16 or higher suggests the presence of depressive symptoms.
The Chinese version of the CES-DC has been validated for use in children in Hong Kong and exhibits adequate internal consistency, as indicated by a Cronbach's alpha coefficient above 0.8.
|
Pre-intervention, Post-intervention (within 1 week immediately after intervention)
|
|
Self-esteem
Time Frame: Pre-intervention, Post-intervention (within 1 week immediately after intervention)
|
Rosenberg's Self-Esteem Scale (RSES) is a widely used tool for measuring global self-worth in both positive and negative aspects of self-perception.
The scale consists of 10 items and has been employed with children.
Participants responded to the items using a 4-point Likert scale, ranging from 1 (strongly disagree) to 4 (strongly agree).
Total scores on the RSES range from 10 to 40, with higher scores indicating higher levels of self-esteem.
The Chinese version of the RSES has demonstrated internal consistency, with a Cronbach's alpha coefficient of 0.78 in a study conducted in Hong Kong.
|
Pre-intervention, Post-intervention (within 1 week immediately after intervention)
|
|
QoL
Time Frame: Pre-intervention, Post-intervention (within 1 week immediately after intervention)
|
The Pediatric Quality-of-Life Inventory 4.0 Generic Core Scale (PedsQL™) is utilized to assess participants' perception of their quality of life (QoL) across various domains, including the impact of disease and treatment on physical functioning (eight items), emotional functioning (five items), social functioning (five items), and school functioning (five items).
Participants rate the extent to which each item has been problematic over the past month, using a scoring system ranging from 0 to 4 (0 = never, 1 = almost never, 2 = sometimes, 3 = often, and 4 = almost always).
The items are then reverse scored and linearly transformed to a 0-100-point scale, with higher scores indicating better health-related QoL.
The Chinese version of the PedsQL™ comprises 23 items and has been validated, demonstrating a Cronbach's alpha coefficient of 0.90.
|
Pre-intervention, Post-intervention (within 1 week immediately after intervention)
|
|
Social functioning outcomes
Time Frame: Pre-intervention, Post-intervention (within 1 week immediately after intervention)
|
The 2nd edition of the Social Responsiveness Scale (SRS-2) is a questionnaire, consisting of 65 items that measure the severity of symptoms associated with ASD.
Participants' parents rate them on a 4-point Likert scale ranging from 0 (never true) to 3 (almost always true).
The SRS includes five subscales: social awareness, social cognition, social communication, social motivation, and autistic mannerisms.
These subscales help assess different aspects of social functioning.
The questionnaire also provides a total score, with higher scores indicating higher levels of impairment.
The SRS demonstrates strong internal consistency, with a Cronbach's alpha coefficient of .97.
The Chinese version of the RSES has demonstrated internal consistency, with a Cronbach's alpha coefficient of 0.9 in a study conducted in China.
|
Pre-intervention, Post-intervention (within 1 week immediately after intervention)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Myrian Sze Nga Fan, MSc, Chinese University of Hong Kong
- Study Chair: Professor William Ho Cheung Li, PhD, Chinese University of Hong Kong
- Study Director: Professor Laurie Long Kwan Ho, PhD, Chinese University of Hong Kong
- Study Chair: Chair Sek Ying Professor Chair Sek Ying, PhD, Chinese University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NTEC-2025-237-T
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
The research team does not have plans to proactively or automatically make the individual participant data (IPD) from this study available to other researchers. However, the IPD may be shared upon request, provided that the requesting party has a valid scientific or medical rationale and obtains the necessary approval from the research team.
Any requests for access to the study's IPD will be reviewed on a case-by-case basis by the research team. Factors that will be considered in evaluating such requests include:
- Scientific merit and validity of the proposed use of the data
- Qualifications and track record of the requesting researcher or research team
- Alignment with the original study objectives and participants' consent
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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