NCT06575244

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2024

Completed
11 months until next milestone

Study Start

First participant enrolled

July 14, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

July 2, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

August 23, 2024

Last Update Submit

June 29, 2025

Conditions

Keywords

Autism spectrum disorderChildrenSailingResilienceNature-based intervention

Outcome Measures

Primary Outcomes (1)

  • Resilience

    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 Outcomes (4)

  • Depressive symptoms

    Pre-intervention, Post-intervention (within 1 week immediately after intervention)

  • Self-esteem

    Pre-intervention, Post-intervention (within 1 week immediately after intervention)

  • QoL

    Pre-intervention, Post-intervention (within 1 week immediately after intervention)

  • Social functioning outcomes

    Pre-intervention, Post-intervention (within 1 week immediately after intervention)

Study Arms (2)

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. The programme will conclude with participants receiving a certificate of participation.

Other: Community-based sailing

Controlled group

PLACEBO COMPARATOR

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.

Other: Crafting activities

Interventions

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 group

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.

Controlled group

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Child Development Disorders, PervasiveAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Officials

  • Myrian Sze Nga Fan, MSc

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR
  • Professor William Ho Cheung Li, PhD

    Chinese University of Hong Kong

    STUDY CHAIR
  • Professor Laurie Long Kwan Ho, PhD

    Chinese University of Hong Kong

    STUDY DIRECTOR
  • Chair Sek Ying Professor Chair Sek Ying, PhD

    Chinese University of Hong Kong

    STUDY CHAIR

Central Study Contacts

Myrian Sze Nga Fan, MSc

CONTACT

William Ho Cheung Li, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The intervention is guided by the Synergy Model of Resilience, integrating Kolb's theory of experiential learning.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

August 23, 2024

First Posted

August 28, 2024

Study Start

July 14, 2025

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

July 2, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

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

Locations