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

University of Macau

Status: Invitation-only

Conditions: Down Syndrome

Treatments: Behavioral: Shared book reading intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06813625

HE-0442-2025

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 2 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Shared book reading intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Shared book reading intervention

Control Group

No Intervention group

Description:

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.