Clinical trial NCT06813625: Shared Book Reading to Promote Mental Well-being Among Young People with and Without Down's Syndrome
Official title: Shared Book Reading to Promote Mental Well-being Among Young People with and Without Down's Syndrome: a Pilot Dyadic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Down Syndrome
Lead sponsor: University of Macau
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria for Participants with Down Syndrome (DS):

* Clinical diagnosis of Down Syndrome (DS).
* Aged 2 years or older.
* Able to participate in the intervention and study evaluation independently or with the support of caregivers or family members.

Inclusion Criteria for University of Macau (UM) Students:

* Aged 18 years or older.
* Able to read and understand books in English or Chinese.
* Able to communicate in English, Mandarin, or Cantonese.
* Do not have severe visual or reading disabilities that may affect reading ability.

Exclusion Criteria:

-Have severe visual or reading disabilities.

Primary outcomes:
measure: PedsQL4.0
timeFrame: 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.
Secondary outcomes:
measure: The Global Perceived Effects scale (GPE)
timeFrame: 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.
measure: EPOCH
timeFrame: 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.
measure: Friendship quality questionnaire (FQQ)
timeFrame: FQQ is assessed at time points: 6 months (T2). This allows for tracking changes in friendship quality over time among participants.
Other outcomes:
Locations:
city: Macau
country: China
facility: University of Macau
Study officials:
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