Viewing Study NCT06575244



Ignite Creation Date: 2024-10-25 @ 7:55 PM
Last Modification Date: 2024-10-26 @ 3:39 PM
Study NCT ID: NCT06575244
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-08-23

Brief Title: Enhance Resilience and Quality of Life of School-aged Children With Autism in Inclusive Education Through Sailing
Sponsor: None
Organization: None

Study Overview

Official Title: The Effects of Community-based Sailing Program on Resilience and Subjective Quality of Life of School-aged Children With Autism in Inclusive Education A Randomized Controlled Trial
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None