Autism Spectrum DisorderNCT07056387
The Effects of a Nurse-led Community-based Sailing Programme on Resilience of School-aged Children With Autism: An RCT
A study testing A nurse-led community-based sailing programme and Crafting activities in people with Autism Spectrum Disorder and Resilience, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder, Resilience
- What is being tested?
- A nurse-led community-based sailing programme and Crafting activities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteHong Kong
- Study dates
- 18 Jul 2025to 8 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- With sailing experience,
- With a history of severe motion sickness symptoms.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a Nurse-led Community-based Sailing Programme on Resilience of School-aged Children With Autism: A Randomised Controlled Trial
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?
Read more
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.
Read the 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 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.
- Conditions
- Autism Spectrum Disorder, Resilience
- Being tested
- A nurse-led community-based sailing programme, Crafting activities
- Keywords
- Sailing, Nature-based interventions, School-aged children
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A nurse-led community-based sailing programmeOther
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).
Crafting activitiesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Crafting activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-intervention, Post-intervention (within 1 week immediately after intervention), and at 3-month and 9-month follow-ups.
Secondary outcomes (4)
Depressive symptoms
Depressive symptoms will be assessed using the Chinese version of the Center for Epidemiologic Studies Depression Scale for Children (CES-DC). The scale includes 20 items across emotional, cognitive, and behavioral domains of depression. Participants rate the frequency of symptoms over the past week on a 4-point Likert scale (0 = not at all, 1 = a little, 2 = some, 3 = a lot). Total scores range from 0 to 60, with higher scores indicating more severe depressive symptoms. A score of 16 or higher suggests the presence of depressive symptoms. The Chinese version of the CES-DC, validated for use in children in Hong Kong, demonstrates strong internal consistency (Cronbach's alpha > 0.8).
Measured: Pre-intervention, Post-intervention (within 1 week immediately after intervention), and at 3-month and 9-month follow-ups.
Self-esteem
Self-esteem will be measured using Rosenberg's Self-Esteem Scale (RSES), a validated tool for assessing global self-worth. The scale comprises 10 items, rated on a 4-point Likert scale (1 = strongly disagree to 4 = strongly agree). Total scores range from 10 to 40, with higher scores reflecting higher levels of self-esteem. The Chinese version of the RSES has been validated in Hong Kong, showing good internal consistency (Cronbach's alpha = 0.78).
Measured: Pre-intervention, Post-intervention (within 1 week immediately after intervention), and at 3-month and 9-month follow-ups.
Quality of life (QoL)
QoL will be assessed using the Pediatric Quality-of-Life Inventory 4.0 Generic Core Scale (PedsQL™). This 23-item questionnaire evaluates physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning (5 items). Participants rate the extent of problems experienced in the past month on a 5-point Likert scale (0 = never to 4 = almost always). Scores are reverse-coded and linearly transformed to a 0-100 scale, with higher scores indicating better QoL. The Chinese version of the PedsQL™, validated in Hong Kong, demonstrates excellent internal consistency (Cronbach's alpha = 0.90).
Measured: Pre-intervention, Post-intervention (within 1 week immediately after intervention), and at 3-month and 9-month follow-ups.
Social functioning outcomes
Social functioning will be evaluated using the 2nd edition of the Social Responsiveness Scale (SRS-2), a 65-item questionnaire assessing ASD-related symptoms. Participants' parents rate each item on a 4-point Likert scale (0 = never true to 3 = almost always true). The SRS-2 includes five subscales: social awareness, social cognition, social communication, social motivation, and autistic mannerisms, as well as a total score. Higher scores indicate greater impairment in social functioning. The Chinese version of the SRS-2 has been validated in China, showing strong internal consistency (Cronbach's alpha = 0.90).
Measured: Pre-intervention, Post-intervention (within 1 week immediately after intervention), and at 3-month and 9-month follow-ups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start18 Jul 2025
- Primary completion17 Jan 2026
- Study completion8 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention is guided by the Synergy Model of Resilience, integrating Kolb's theory of experiential learning.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Sailability Hong Kong
- Responsible party
- Principal investigator, Myrian Sze Nga Fan, Chinese University of Hong Kong
- Investigators
- Myrian Sze Nga Fan, MSc, Principal investigator, Chinese University of Hong KongWilliam Ho Cheung Li, PhD, Study director, Chinese University of Hong KongLaurie Long Kwan Ho, PhD, Study director, Chinese University of Hong KongSek Ying Chair, PhD, Study chair, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056387
- Sponsor's protocol ID
- CREC 2025.237-T
- Status last verified
- Oct 2026
- First submitted
- 29 Jun 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Nurse-led Community-based Sailing Programme on Resilience of School-aged Children With Autism: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07056387
- Acronym / sponsor ID
- CREC 2025.237-T
- Conditions
- Autism Spectrum Disorder, Resilience
- Keywords
- Sailing, Nature-based interventions, School-aged children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Sailability Hong Kong
- Study start
- 18 Jul 2025 (actual)
- Primary completion
- 17 Jan 2026 (actual)
- Study completion
- 8 Oct 2026 (actual)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The intervention is guided by the Synergy Model of Resilience, integrating Kolb's theory of experiential learning.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: A nurse-led community-based sailing programmeEligible 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. |
| Attention controlled Group | Active comparator | Other: Crafting activitiesThe 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. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- With sailing experience,
- With a history of severe motion sickness symptoms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A nurse-led community-based sailing programmeA 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). | Other | Intervention group |
| Crafting activitiesParticipants 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. | Other | Attention controlled Group |
Primary outcome
Resilience
Time frame: 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.
4 secondary outcomes
Depressive symptoms
Time frame: Pre-intervention, Post-intervention (within 1 week immediately after intervention), and at 3-month and 9-month follow-ups.
Self-esteem
Time frame: Pre-intervention, Post-intervention (within 1 week immediately after intervention), and at 3-month and 9-month follow-ups.
Quality of life (QoL)
Time frame: Pre-intervention, Post-intervention (within 1 week immediately after intervention), and at 3-month and 9-month follow-ups.
Social functioning outcomes
Time frame: Pre-intervention, Post-intervention (within 1 week immediately after intervention), and at 3-month and 9-month follow-ups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myrian Sze Nga Fan, MSc principal investigator
Chinese University of Hong Kong
William Ho Cheung Li, PhD study director
Chinese University of Hong Kong
Laurie Long Kwan Ho, PhD study director
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A nurse-led community-based sailing programme and Crafting activities in people with Autism Spectrum Disorder and Resilience, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resilience (time frame: Pre-intervention, Post-intervention (within 1 week immediately after intervention), and at 3-month and 9-month follow-ups.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.