NCT07056387

Brief Summary

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.

Trial Health

65
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Trial Health Score

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

Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Aug 2025

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

Study Progress53%
Aug 2025Dec 2026

First Submitted

Initial submission to the registry

June 29, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 9, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

August 15, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

July 9, 2025

Status Verified

June 1, 2025

Enrollment Period

8 months

First QC Date

June 29, 2025

Last Update Submit

June 29, 2025

Conditions

Keywords

SailingNature-based interventionsSchool-aged children

Outcome Measures

Primary Outcomes (1)

  • Resilience

    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.

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

Secondary Outcomes (4)

  • 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.

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.

Other: A nurse-led community-based sailing programme

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.

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.

Attention 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 an 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

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Myrian Sze Nga Fan, MSc

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR
  • William Ho Cheung Li, PhD

    Chinese University of Hong Kong

    STUDY DIRECTOR
  • Laurie Long Kwan Ho, PhD

    Chinese University of Hong Kong

    STUDY DIRECTOR
  • Sek Ying Chair, 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
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.
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

June 29, 2025

First Posted

July 9, 2025

Study Start

August 15, 2025

Primary Completion

April 15, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

July 9, 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