STUDY PROTOCOL article
Front. Public Health
Sec. Public Mental Health
Volume 13 - 2025 | doi: 10.3389/fpubh.2025.1604241
This article is part of the Research TopicMental Health of Vulnerable Groups: Predictors, Mechanisms, and InterventionsView all 32 articles
Shared Book Reading to Promote Mental Well-being Among Young People with and without Down Syndrome: A Pilot Dyadic Randomized Controlled Trial
Provisionally accepted
- University of Macau, Taipa, China
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Background: With societal progress and a deepening understanding of Down syndrome (DS), research focus has shifted toward improving the quality of life and education for youth with DS. This study aims to determine the feasibility and estimate the preliminary effectiveness of a dyadic shared book reading program on the health-related quality of life of youth with DS, the mental well-being of university students, and actor–partner outcomes to inform a future definitive trial. Methods: This study is an 8-week pilot dyadic randomized controlled trial comparing a shared book reading intervention to a minimal activity control. The study will then continue for 12 months as a single-arm cohort study. Youg people with DS and university students will be recruited, formed into dyads, and then randomized to either the intervention or control group. The intervention involves pairing a young people with DS weith a university student for a weekly, one-hour shared book reading session. The control group will be provided with three books to read at their leisure over the 8 weeks. The primary outcome is the health-related quality of life of young people with DS, measured using the Pediatric Quality of Life Inventory. Secondary outcomes include the Engagement, Perseverance, Optimism, Connectedness, and Happiness scale for measuring well-being. The Friendship Quality Questionnaire will be used to measure the dyad’s level of friendship in the intervention group at 8-weeks. Measurements will be taken at baseline (T0) and at 8 weeks (T1). After 8 weeks, all participants will be offered the opportunity to continue in the study, joining the weekly shared book reading intervention; outcome measures will then be assessed at 6-month (T2) and 12-month (T3) follow-ups. Mixed linear regression models will be used to compare the intervention and control groups at 8 weeks. For the 6-month and 12-month follow-ups, change scores from baseline will be analyzed to test for potential long-term effect. Discussion: This study focuses on the mental well-being of young people with DS and university students by promoting psychological health through shared book reading activities. Clinical Trial Registration: Clinicaltrials.gov, identifier NCT06813625.
Keywords: shared book reading, Down Syndrome, Young people, Mental well-being, randomized controlled trial, protocol, Pilot Study
Received: 01 Apr 2025; Accepted: 13 Oct 2025.
Copyright: © 2025 Huang, Long, Zhang, Xu and Smith. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Robert David Smith, robsmith@um.edu.mo
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