The Effects of a Nurse-led Community-based Sailing Programme on Resilience of School-aged Children With Autism

NCT ID: NCT06575244

Last Updated: 2025-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-14

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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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. The results will be analyzed using the Generalized Estimating Equation (GEE) model, following the intention-to-treat (ITT) principle to ensure the reliability of findings.

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.

Conditions

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Autistic Disorders Spectrum Child Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The intervention is guided by the Synergy Model of Resilience, integrating Kolb's theory of experiential learning.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Due to the limited resources available, the study team has decided to adopt a volunteer-based approach for the blinded outcome assessor. Individuals with relevant experience working with children with autism spectrum disorder (ASD) will be recruited and trained to perform the data collection for the study.

The researchers recognize the importance of ensuring the reliability and validity of the study's findings. To address this, the volunteer assessors will undergo appropriate training and supervision to equip them with the necessary skills and knowledge to conduct the assessments in a rigorous and unbiased manner.

By leveraging the expertise and commitment of volunteers with prior experience in the ASD population, the study team aims to overcome the challenge of limited resources and implement the blinded assessment protocol as intended. This approach will help maintain the integrity of the study's methodology and the credibility of the final results.

Study Groups

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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.

Group Type EXPERIMENTAL

Community-based sailing

Intervention Type OTHER

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).

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.

Group Type PLACEBO_COMPARATOR

Crafting activities

Intervention Type OTHER

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.

Interventions

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Community-based sailing

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).

Intervention Type OTHER

Crafting activities

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. be between the ages of 7 and 12,
2. have a confirmed diagnosis of ASD,
3. be enrolled in inclusive education school,
4. possess the ability to complete the questionnaire in Chinese,
5. be able to communicate in Chinese.

Exclusion Criteria

* With sailing experience,
* With a history of severe motion sickness symptoms.
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sailability Hong Kong

UNKNOWN

Sponsor Role collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Myrian Sze Nga Fan

PhD Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Myrian Sze Nga Fan, MSc

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Professor William Ho Cheung Li, PhD

Role: STUDY_CHAIR

Chinese University of Hong Kong

Professor Laurie Long Kwan Ho, PhD

Role: STUDY_DIRECTOR

Chinese University of Hong Kong

Chair Sek Ying Professor Chair Sek Ying, PhD

Role: STUDY_CHAIR

Chinese University of Hong Kong

Locations

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The Nethersole School of Nursing, the Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Central Contacts

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Myrian Sze Nga Fan, MSc

Role: CONTACT

852-39438177

William Ho Cheung Li, PhD

Role: CONTACT

852-39430889

Facility Contacts

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Myrian Sze Nga Fan, MSc

Role: primary

852-97870161

William Ho Cheung Li, PhD

Role: backup

852-39430889 ext. Fan

Other Identifiers

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NTEC-2025-237-T

Identifier Type: -

Identifier Source: org_study_id

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