Enhance Resilience and Quality of Life of School-aged Children With Autism in Inclusive Education Through Sailing
NCT Number: NCT06575244
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Autistic Disorders Spectrum|Child Development|Well-Being, Psychological
Interventions: OTHER: Community-based sailing|OTHER: Usual care
Sponsor: Chinese University of Hong Kong
Sex: FEMALE
Age: CHILD
Enrollment: 144
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2025-01-02
Completion Date: 2026-12-31
Locations: The Nethersole School of Nursing, the Chinese University of Hong Kong, Hong Kong, Hong Kong

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.

Primary Outcome Measures: 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), and a 6-month follow up assessment
Secondary Outcome Measures: Subjective Quality of life, 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., Pre-intervention, Post-intervention (within 1 week immediately after intervention), and a 6-month follow up assessment|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., Pre-intervention, Post-intervention (within 1 week immediately after intervention), and a 6-month follow up assessment|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., Pre-intervention, Post-intervention (within 1 week immediately after intervention), and a 6-month follow up assessment|Behavioral functioning outcomes, 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., Pre-intervention, Post-intervention (within 1 week immediately after intervention), and a 6-month follow up assessment|Sensory functioning outcomes, 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., Pre-intervention, Post-intervention (within 1 week immediately after intervention), and a 6-month follow up assessment|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., Pre-intervention, Post-intervention (within 1 week immediately after intervention), and a 6-month follow up assessment