Shared Book Reading to Promote Mental Well-being Among Young People with and Without Down's Syndrome
- Conditions
- Down Syndrome
- Registration Number
- NCT06813625
- Lead Sponsor
- University of Macau
- Brief Summary
Abstract Background: With the progress of society and the deepening of people's understanding of Down syndrome (DS), research has shifted focus on how to improve the quality of life and education for young people with DS. This study shall pilot a shared book reading intervention to test for potential benefit and feasibility.
Methods: This study is an 8 weeks long pilot dyadic randomized controlled trial (RCT) comparing a shared book reading intervention to a minimal activity control, this study will then continue for 12 months as a single arm cohort study. Young people with DS and university undergraduate students will be recruited and formed into dyads then randomized to either intervention or control. The shared book reading activity will include partnering young people with DS and university students together for a weekly, 1-hour shared book reading session. The control group will be supplied with three books they can read in their free time during 8 weeks. The primary outcomes included young people with DS health-related quality of life measured using the Children's Quality of Life Scale (PedsQL4.0). Secondary outcomes include mental well-being in university students using the Engagement, Perseverance, Optimism, Connectedness, and Happiness scale (EPOCH). Measurements will be made at baseline (T0) and 8-week (T1). After 8 weeks all participants will be offered to continue in the study where all participants will join the shared book reading weekly intervention and outcomes measures will be made at 6-month (T2), and 12-month (T3) follow-up. Mixed linear regression models shall be conducted comparing intervention and control group at 8 weeks. At 6-months and 12-months follow-up change scores from baseline will be analyzed to test for potential long-term effect.
Anticipated results: If our pilot study can show that shared book reading activities for people with DS can be of benefit and feasible, this can lead to a fully powered randomized controlled trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 40
Not provided
-Have severe visual or reading disabilities.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method PedsQL4.0 PEDSQL4.0 is assessed at three time points: Baseline (T0), 8 weeks (T1), and 6 months (T2). This allows for tracking changes in health-related quality of life over time among participants. Health related quality of life for young people with DS will be measured using the Children's Quality of Life Scale (PedsQL4.0). The Child Quality of Life Scale (PedsQL) is a common tool used to assess a child's quality of life and can be used to measure quality of life (QOL) in children and adolescents aged 2-18 years with acute or chronic medical conditions, including DS. The PedsQL4.0 covering domains of physical functioning, emotional state, social interaction, and school performance, as well as providing a total score for overall quality of life. The PedsQL4.0 items ask to what extent the participant has had problems in the past month. The higher the score on the PedsQL4.0 tool indicates a higher the quality of life. The questionnaire showed good psychometric characteristics among young people and internal consistency (Cronbach's alpha range was 0.66 to 0.93).
- Secondary Outcome Measures
Name Time Method The Global Perceived Effects scale (GPE) GPE is assessed at this time points: 8 weeks (T1). This allows for tracking changes in health-related quality of life over time among participants. The Global Perceived Effects scale (GPE) used in the responsiveness analysis and for determining the minimal important change. Caregivers choosing response options"very much improved"and"much improved"were considered to have "importantly improved,"and those choosing options 3-5 ("a little improved, no change and a little deterioration") were considered to be"stable."For research or clinical evaluation to understand the impact of shared book reading activities on children's quality of life and their caregivers. This information is valuable to doctors, researchers, and healthcare providers because it can help them evaluate the effects of interventions and improve future intervention strategies.
EPOCH EPOCH is assessed at three time points: Baseline (T0), 8 weeks (T1), and 6 months (T2). This allows for tracking changes in mental health over time among participants. The EPOCH Measure of Adolescent Well-being is a scale used to assess positive psychological traits in adolescents. It consists of 20 items with five dimensions: Engagement, Perseverance, Optimism, Connectedness and Happiness. This scale was developed to assess five positive psychological traits that may promote well-being, physical health, and other positive outcomes in adulthood. The scale is an effective tool that provides a short and reliable measurement tool for schools or organizations to help assess a youth's sense of psychological well-being.
* Score Range: Typical Likert-type scales (e.g., 1-5 or 0-4) are often used, so the total score range would depend on the response format (e.g., 20-100 if a 1-5 scale is used).
* Interpretation: Higher scores indicate better outcomes (i.e., greater psychological well-being).Friendship quality questionnaire (FQQ) FQQ is assessed at time points: 6 months (T2). This allows for tracking changes in friendship quality over time among participants. Friendship Quality Questionnaire (FQQ)
* Purpose: Assesses the quality of friendship among children and adolescents across five dimensions.
* Dimensions: Companionship、Conflict、Helpfulness、Security and Closeness.
* Score Range: If the questionnaire uses a Likert-type scale (e.g., 1-5 or 0-4), the total score range would depend on the number of items and response options.
* Interpretation: Higher scores indicate better outcomes (i.e., higher quality of friendship).
Related Research Topics
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Trial Locations
- Locations (1)
University of Macau
🇨🇳Macau, China
University of Macau🇨🇳Macau, China