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

Официальное название

Shared Book Reading to Promote Mental Well-being Among Young People with and Without Down's Syndrome: a Pilot Dyadic Randomized Controlled Trial

Обзор

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.

Вмешательства

• Поведенческое Shared book reading intervention
  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

Первичные конечные точки

• PedsQL4.0 [Срок оценки: 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.]

Вторичные конечные точки (3)

• The Global Perceived Effects scale (GPE) [Срок оценки: 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.]
• EPOCH [Срок оценки: 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.]
• Friendship quality questionnaire (FQQ) [Срок оценки: FQQ is assessed at time points: 6 months (T2). This allows for tracking changes in friendship quality over time among participants.]

Критерии участия

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.

Критерии исключения

-Have severe visual or reading disabilities.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 1 центр

• University of Macau — Macau

Публикации

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• Frizelle P, O'Donovan S, Jolley M, Martin L, Hart N. The co-construction of a reading assessment measure with adults with Down syndrome: a meaningful literacy approach. Front Psychol. 2023 Jul 20;14:1173300. doi: 10.3389/fpsyg.2023.1173300. eCollection 2023. PMID 37546441
• Dong Y, Mo J, Gong B, Jin R, Zheng H, Chow BW. Effects of Using Prompts During Parent-Child Shared Reading on the Language Development of Mildly Autistic Children. J Autism Dev Disord. 2026 Jun;56(6):2102-2118. doi: 10.1007/s10803-024-06712-9. Epub 2025 Jan 11. PMID 39797957
• Akkarakittichoke N, Janwantanakul P, Kanlayanaphotporn R, Jensen MP. Responsiveness of the UW Concerns About Pain Scale and UW Pain-Related Self-Efficacy Scale in Individuals With Chronic Low Back Pain. Clin J Pain. 2022 Jul 1;38(7):476-483. doi: 10.1097/AJP.0000000000001043. PMID 35686577

Идентификаторы

NCT: NCT06813625 · HE-0442-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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