Autistic Disorders SpectrumNCT06575244
The Effects of a Nurse-led Community-based Sailing Programme on Resilience of School-aged Children With Autism
A study testing Community-based sailing and Crafting activities in people with Autistic Disorders Spectrum and Child Development, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Autistic Disorders Spectrum, Child Development
- What is being tested?
- Community-based sailing and Crafting activities
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteHong Kong
- Study dates
- 14 Jul 2025to 10 Oct 2025
- 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 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.
Hong Kong1 site
The Nethersole School of Nursing, the Chinese University of Hong Kong
Hong Kong
About this study
Official title: 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?
Read more
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.
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 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.
- Conditions
- Autistic Disorders Spectrum, Child Development
- Being tested
- Community-based sailing, Crafting activities
- Keywords
- Autism spectrum disorder, Children, Sailing, Resilience, Nature-based intervention
- Medical subject headings
- Child Development Disorders, Pervasive, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based sailingOther
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. The programme will conclude with participants receiving a certificate of participation. Receives: 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. Receives: Other: Crafting activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-intervention, Post-intervention (within 1 week immediately after intervention)
Secondary outcomes (4)
Depressive symptoms
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.
Measured: Pre-intervention, Post-intervention (within 1 week immediately after intervention)
Self-esteem
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.
Measured: Pre-intervention, Post-intervention (within 1 week immediately after intervention)
QoL
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.
Measured: Pre-intervention, Post-intervention (within 1 week immediately after intervention)
Social functioning outcomes
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.
Measured: Pre-intervention, Post-intervention (within 1 week immediately after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start14 Jul 2025
- Primary completion30 Sep 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic Disorders SpectrumStudies 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
- 36 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 KongProfessor William Ho Cheung Li, PhD, Study chair, Chinese University of Hong KongProfessor Laurie Long Kwan Ho, PhD, Study director, Chinese University of Hong KongChair Sek Ying Professor Chair Sek Ying, PhD, Study chair, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575244
- Sponsor's protocol ID
- NTEC-2025-237-T
- Status last verified
- May 2026
- First submitted
- 23 Aug 2024
- Last updated
- 13 May 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 May 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 Pilot Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06575244
- Acronym / sponsor ID
- NTEC-2025-237-T
- Conditions
- Autistic Disorders Spectrum, Child Development
- Keywords
- Autism spectrum disorder, Children, Sailing, Resilience, Nature-based intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Sailability Hong Kong
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 28 Aug 2024 (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 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
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 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: Community-based sailingEligible 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. |
| Controlled group | Placebo comparator | Other: Crafting activitiesParticipants 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. |
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 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 |
|---|---|---|
| Community-based sailingA 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 | Controlled group |
Primary outcome
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.
4 secondary outcomes
Depressive symptoms
Time frame: Pre-intervention, Post-intervention (within 1 week immediately after intervention)
Self-esteem
Time frame: Pre-intervention, Post-intervention (within 1 week immediately after intervention)
QoL
Time frame: 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)
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 May 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
Professor William Ho Cheung Li, PhD study chair
Chinese University of Hong Kong
Professor 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 Community-based sailing and Crafting activities in people with Autistic Disorders Spectrum and Child Development, 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 May 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. Some participants in this study may receive a placebo. 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)). 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 May 2026.