Clinical trial NCT06575244: The Effects of the Community-based Sailing Programme in Enhancing Resilience of School-aged Children with Autism: a Pilot Randomised Controlled Study
Official title: The Effects of Community-based Sailing Program on Resilience of School-aged Children with Autism: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autistic Disorders Spectrum
Child Development
Well-Being, Psychological
Keywords: Autism spectrum disorder
Children
Sailing
Quality of life
Resilience
Nature-based intervention
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 144
Sex: FEMALE
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention is guided by the Synergy Model of Resilience, integrating Kolb's theory of experiential learning. The Synergy Model of Resilience emphasises the importance of "Resistance to Adversity", where the CBS program is designed to integrate the four-stage learning process based on Kolb's theory in facilitating participants' understanding of resilience. The presence of protective and promotive factors leads to positive outcomes related to achievement and flourishing.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Does community-based sailing improve the resilience of participants? Does community-based sailing 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:

Participate in a community-based sailing program over four days, with each day consisting of 4 sessions, each lasting an hour, for a total of 16 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 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, using community-based participatory research initiatives 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 charity organization Sailability Hong Kong, recruiting 25 children with autism aged 7 to 12 years. 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 nurse-led CBS program in enhancing 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. If proven effective, it could refine nursing care by expanding its traditional role and delivering developmentally appropriate care to support the holistic health of children with ASD. It could significantly influence the integration of NBIs as an essential component in interdisciplinary care delivery by leveraging community-based support outside the healthcare system.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Resilience
timeFrame: Pre-intervention, Post-intervention (within 1 week immediately after intervention)
Secondary outcomes:
measure: Depressive symptoms
timeFrame: Pre-intervention, Post-intervention (within 1 week immediately after intervention)
measure: Self-esteem
timeFrame: Pre-intervention, Post-intervention (within 1 week immediately after intervention)
measure: QoL
timeFrame: Pre-intervention, Post-intervention (within 1 week immediately after intervention)
measure: Social functioning outcomes
timeFrame: Pre-intervention, Post-intervention (within 1 week immediately after intervention)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Nethersole School of Nursing, the Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Myrian Sze Nga Fan, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese University of Hong Kong
name: William Ho Cheung Li, PhD
role: STUDY_CHAIR
affiliation: Chinese University of Hong Kong
name: Laurie Long Kwan Ho, PhD
role: STUDY_DIRECTOR
References: