Enhance Resilience and Quality of Life of School-aged Children With Autism in Inclusive Education Through Sailing

Not Applicable

Not yet recruiting

• Conditions: Child Development; Well-Being, Psychological; Autistic Disorders Spectrum
• Interventions: Other: Community-based sailing; Other: Usual care

• Registration Number: NCT06575244
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

The goal of this controlled trial is to learn if community-based sailing can enhance the resilience and quality of life in school-aged children with autism in inclusive education. It will also learn about its impact on functioning outcomes. The main questions it aims to answer are:

Does community-based sailing improve the resilience of participants? Does community-based sailing improve the quality of life, self-esteem, social, sensory, and behavioral functioning outcomes of participants?

Researchers will compare the effect of community-based sailing to usual care to see if participation in community-based sailing works to improve the well-being of children with autism in inclusive education.

Participants will:

Participate in a community-based sailing program once a week for two weeks, totaling 14 hours.

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 behavior, interests, or activities. This study seeks to address the outcome gap in the literature, the subjective quality of life (QoL) of children with ASD, and expand their natural environment to include nature and the community, using community-based participatory research initiatives. Within the scope of social prescribing, particular attention can be given to nature-based interventions (NBIs), where a positive association between NBIs involving group-based recreational activities utilizing experiential learning approaches, and positive short-term outcomes on sensory, social, and behavioral functioning for children with ASD, and possible with subjective QoL although it is limited in narrative synthesis.

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 subjective QoL and other relevant psychosocial outcomes (depressive symptoms, resilience, and self-esteem) based on the developmental stage of children with ASD during the school-aged period and the natural environment in inclusive education. A study revealed that school-aged children with ASD in inclusive education significantly exhibited more depressive symptoms, lower subjective QoL, lower resilience, and lower self-esteem, suggesting that inclusion in education alone may not be sufficient to support their well-being. Resilience is also identified as a significant mediator between depressive symptoms and psychosocial health, highlighting the potential of resilience-focused interventions in enhancing their subjective QoL.

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 study highlighted the positive impact of the community-based initiative within CBS that expanded the natural environment of school-aged children with ASD in inclusive education to include nature and the community through a process of empowerment supported by active and extensive community engagement, with recognition of the inherent role of resilience in CBS.

After that, a CBS program has been developed based on a theoretical framework. This study aims to evaluate the effects of a newly developed CBS program based on the Medical Research Council (MRC)/ National Institute for Health and Care Research (NIHR) framework for developing and evaluating complex interventions, on resilience and the subjective QoL of school-aged children with ASD in inclusive education. This study will employ a randomized controlled trial (RCT) with an assessor-blind design, in collaboration with the community charity organization Sailability Hong Kong, recruiting 144 children with autism aged 7 to 12 years for a two-week intervention, totaling 14 hours. 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 study aims to evaluate the effects of the developed "RAWBONE" CBS program in enhancing resilience and the subjective QoL of school-aged children with ASD in inclusive education.

The study hypothesizes that, in comparison to the control group with usual care, school-aged children with ASD in inclusive education who participate in the intervention group will exhibit (1) increased levels of resilience, (2) improved subjective QoL, (3) reduced depressive symptoms, (4) enhanced self-esteem, (5) improved sensory functioning, (6) improved social functioning, and (7) improved behavioral functioning immediately after the intervention and at the 6-month follow-up assessment.

The innovative aspect of this study lies in utilizing CBS as a therapeutic approach aimed at enhancing the QoL and community participation of children with ASD. 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 expand the natural environment of children with autism beyond traditional educational and clinical settings into broader community engagement. The study emphasizes the pivotal role of nurses in organizing patient care and improving outcomes through fostering collaboration among multidisciplinary professionals and the community using social prescribing initiatives, thereby bridging organizational and disciplinary boundaries.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-23
• Study First Submitted QC: 2024-08-26
• Last Update Submitted: 2024-08-26
• Study First Posted: 2024-08-28
• Last Update Posted: 2024-08-28
• Study Start: 2025-01-02
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 144

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Community-based sailing	Eligible participants will take part in the RAWBONE sailing program, which will utilize dinghies with universal design known for their exceptional stability to prioritize safety. The instructor-to-participant ratio will be 1:6, with each participant accompanied by a volunteer on a 1:1 ratio, and a safety boat present. The program will conclude with participants receiving a certificate of participation. Participants will receive a social skills booklet that is identical to the placebo received by the control group.
Controlled group	Usual care	The control group participants will be directed to continue their usual routines while refraining from sailing-related activities and will be provided with a booklet containing social skills content as a placebo, with no additional support during the intervention period.
Intervention group	Usual care	Eligible participants will take part in the RAWBONE sailing program, which will utilize dinghies with universal design known for their exceptional stability to prioritize safety. The instructor-to-participant ratio will be 1:6, with each participant accompanied by a volunteer on a 1:1 ratio, and a safety boat present. The program will conclude with participants receiving a certificate of participation. Participants will receive a social skills booklet that is identical to the placebo received by the control group.

Primary Outcome Measures

Name	Time	Method
Resilience	Pre-intervention, Post-intervention (within 1 week immediately after intervention), and a 6-month follow up assessment	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.

Secondary Outcome Measures

Name	Time	Method
Self-esteem	Pre-intervention, Post-intervention (within 1 week immediately after intervention), and a 6-month follow up assessment	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.
Social functioning outcomes	Pre-intervention, Post-intervention (within 1 week immediately after intervention), and a 6-month follow up assessment	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.
Depressive symptoms	Pre-intervention, Post-intervention (within 1 week immediately after intervention), and a 6-month follow up assessment	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.
Subjective Quality of life	Pre-intervention, Post-intervention (within 1 week immediately after intervention), and a 6-month follow up assessment	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.
Behavioral functioning outcomes	Pre-intervention, Post-intervention (within 1 week immediately after intervention), and a 6-month follow up assessment	Aberrant Behavior Checklist-Community (ABC-C) is a comprehensive measure that assesses various challenging behaviors associated with ASD. It consists of a 58-item checklist with five subscales: Irritability, Lethargy, Stereotypy, Hyperactivity, and Inappropriate Speech. Each subscale demonstrates high internal consistency, recognized validity, and sufficient reliability. The ABC-C utilizes a 4-point rating scale (0-3), where higher scores indicate more problematic behaviors. The Chinese version of ABC-C has demonstrated internal consistency, with a Cronbach's alpha coefficient of 0.75 to 0.96 among all subscales.
Sensory functioning outcomes	Pre-intervention, Post-intervention (within 1 week immediately after intervention), and a 6-month follow up assessment	The Chinese Sensory Profile (CSP) is an adapted version of the Sensory Profile (SP), comprising 100 items tailored for clarity and cultural relevance, serving as a parent-reported measure to evaluate children's responses to sensory experiences within their daily routines. Scoring in the CSP encompasses six sensory systems and two behavioral category subscales, which include auditory processing (8 items), visual processing (14 items), taste/smell processing (6 items), body position (8 items), movement (17 items), touch processing (22 items), activity level (5 items), and social/emotional responses (20 items). A study conducted in Taiwan demonstrated strong internal consistency, with a Cronbach's alpha coefficient ranging from 0.75 to 0.93.

Trial Locations

Locations (1)

The Nethersole School of Nursing, the Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong