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

February 2, 2025 updated by: Robert Smith, University of Macau

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Macau, China
        • University of Macau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Health related quality of life for young people with DS will be measured using the Children's Quality of Life Scale (PedsQL4.0). The Child Quality of Life Scale (PedsQL) is a common tool used to assess a child's quality of life and can be used to measure quality of life (QOL) in children and adolescents aged 2-18 years with acute or chronic medical conditions, including DS. The PedsQL4.0 covering domains of physical functioning, emotional state, social interaction, and school performance, as well as providing a total score for overall quality of life. The PedsQL4.0 items ask to what extent the participant has had problems in the past month. The higher the score on the PedsQL4.0 tool indicates a higher the quality of life. The questionnaire showed good psychometric characteristics among young people and internal consistency (Cronbach's alpha range was 0.66 to 0.93).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Global Perceived Effects scale (GPE)
Time Frame: 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.
The Global Perceived Effects scale (GPE) used in the responsiveness analysis and for determining the minimal important change. Caregivers choosing response options"very much improved"and"much improved"were considered to have "importantly improved,"and those choosing options 3-5 ("a little improved, no change and a little deterioration") were considered to be"stable."For research or clinical evaluation to understand the impact of shared book reading activities on children's quality of life and their caregivers. This information is valuable to doctors, researchers, and healthcare providers because it can help them evaluate the effects of interventions and improve future intervention strategies.
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
Time Frame: 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.

The EPOCH Measure of Adolescent Well-being is a scale used to assess positive psychological traits in adolescents. It consists of 20 items with five dimensions: Engagement, Perseverance, Optimism, Connectedness and Happiness. This scale was developed to assess five positive psychological traits that may promote well-being, physical health, and other positive outcomes in adulthood. The scale is an effective tool that provides a short and reliable measurement tool for schools or organizations to help assess a youth's sense of psychological well-being.

  • Score Range: Typical Likert-type scales (e.g., 1-5 or 0-4) are often used, so the total score range would depend on the response format (e.g., 20-100 if a 1-5 scale is used).
  • Interpretation: Higher scores indicate better outcomes (i.e., greater psychological well-being).
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)
Time Frame: FQQ is assessed at time points: 6 months (T2). This allows for tracking changes in friendship quality over time among participants.

Friendship Quality Questionnaire (FQQ)

  • Purpose: Assesses the quality of friendship among children and adolescents across five dimensions.
  • Dimensions: Companionship、Conflict、Helpfulness、Security and Closeness.
  • Score Range: If the questionnaire uses a Likert-type scale (e.g., 1-5 or 0-4), the total score range would depend on the number of items and response options.
  • Interpretation: Higher scores indicate better outcomes (i.e., higher quality of friendship).
FQQ is assessed at time points: 6 months (T2). This allows for tracking changes in friendship quality over time among participants.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Macau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 8, 2025

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

February 2, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 2, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE-0442-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Due to the small number of children with Down's syndrome in Macau SAR and the scope of this study, anonymized individual data may become identifiable.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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