Shared Book Reading to Promote Mental Well-being Among Young People with and Without Down's Syndrome

Sponsor
University of Macau
Study ID
NCT06813625
Status
Enrolling By Invitation

Conditions

  • Down Syndrome

Eligibility Criteria

Sex
ALL
Age
2 Years - 35 Years
Healthy Volunteers
Accepted

Interventions

  • Shared book reading intervention — BEHAVIORAL
    The intervention involved us pairing each teen DS with a college student to form a duo. Each group consists of one person with DS and at least one college student who will work together throughout the shared reading intervention. A weekly event hosted by a graduate student. It begins with ice-breaking activities such as color and music games to promote social interaction between participants. After the game, participants chose from a selection of 20 books suitable for different age groups. They can choose their own reading method, such as reading aloud or assigning roles, and are encouraged to share experiences in their own duos or in a large group of multiple duos. The session ends with a sharing and reflection activity where participants can discuss what they have read and plan for the next session.

Study Details

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.

Key Dates

First listed
Feb 7, 2025
Start date
Feb 8, 2025
Status verified
Feb 2025
Primary completion
Jan 31, 2026
Completion
Jan 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Shared book reading intervention
    An 8-week pilot binary randomized controlled trial involving one hour of shared book reading per week in young people with and without Down syndrome.
  • No Intervention: Control Group
    Those in the control group will be informed that they will wait 8 weeks before they can join the shared book reading sessions. Dyads will not be put in contact with each other. To keep young people with DS engaged with the study, those in the control group will be offered 3 books, from the selection of 20, that they can read themselves during the control period. After the 8-week period those that attend the shared book reading sessions will be introduced to their dyadic partner to participate in the sessions fully.

Primary Outcome Measure

PedsQL4.0 [ Time Frame: 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. ]

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