Down SyndromeNCT06813625
Shared Book Reading to Promote Mental Well-being Among Young People with and Without Down's Syndrome
A study testing Shared book reading intervention in people with Down Syndrome, run by University of Macau at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Shared book reading intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 8 Feb 2025to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- -Have severe visual or reading disabilities.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Conditions
- Down Syndrome
- Being tested
- Shared book reading intervention
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared book reading interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Shared book reading intervention | Experimental | 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. Receives: Behavioral: Shared book reading intervention |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
PedsQL4.0
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).
Measured: 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 (3)
The Global Perceived Effects scale (GPE)
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.
Measured: 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
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).
Measured: 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)
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).
Measured: FQQ is assessed at time points: 6 months (T2). This allows for tracking changes in friendship quality over time among participants.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start8 Feb 2025 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Macau
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Smith, University of Macau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813625
- Sponsor's protocol ID
- HE-0442-2025
- Status last verified
- Feb 2025
- First submitted
- 27 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
Perra A, Primavera D, Leonetti V, Montisci R, Carta D, Lorrai G, Locci A, Chessa L, Scuteri A, Cossu G, Nardi AE, Valmaggia L, Galetti A, De Lorenzo V, Sancassiani F, Carta MG. Virtual reality cognitive remediation tool for individuals with mild cognitive impairment: study protocol for a feasibility randomized clinical trial. Front Public Health. 2024 Nov 22;12:1477279. doi: 10.3389/fpubh.2024.1477279. eCollection 2024.
PubMed 39651467Peiris DLIHK, Duan Y, Vandelanotte C, Liang W, Baker JS. In-classroom physical activity breaks program among school children in Sri Lanka: study protocol for a randomized controlled trial. Front Public Health. 2024 Apr 22;12:1360210. doi: 10.3389/fpubh.2024.1360210. eCollection 2024.
PubMed 38711768Bridi D, Valentini NC, Deslandes AC, Copetti F. Focused attention and intrinsic motivation using animations for instruction of fundamental motor skills in children with Down syndrome. J Intellect Disabil Res. 2024 Aug;68(8):954-968. doi: 10.1111/jir.13140. Epub 2024 Apr 21.
PubMed 38644604Hsu CF, Jiang Q, Rao SY. Category-Based Effect on False Memory of People with Down Syndrome. Brain Sci. 2024 May 24;14(6):538. doi: 10.3390/brainsci14060538.
PubMed 38928536Grover V, Snow CE, Evans L, Stromme H. Overlooked advantages of interactive book reading in early childhood? A systematic review and research agenda. Acta Psychol (Amst). 2023 Sep;239:103997. doi: 10.1016/j.actpsy.2023.103997. Epub 2023 Aug 8.
PubMed 37562321Frizelle 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.
PubMed 37546441Dong 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.
PubMed 39797957Akkarakittichoke 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.
PubMed 35686577Wiwaha G, Sari DM, Biben V, Sunjaya DK, Hilmanto D. Translation and validation of Indonesian version of Pediatric Quality of Life Inventory (PedsQL) Neuromuscular Module. Health Qual Life Outcomes. 2022 Feb 24;20(1):33. doi: 10.1186/s12955-022-01933-x.
PubMed 35209927Kamdem F, Meyanga Ngoah J, Nganou Gnindjio CN, Mekoulou Ndongo J, Ba H, Mouliom S, Viche L, Ngote H, Kenmegne C, Tsague Kengni H, Ndom Ebongue MS, Djibrilla S, Bika Lele EC. Pattern and determinants of health-related quality of life of adolescents with congenital heart disease in Cameroon: A single-center cross-sectional study. JRSM Cardiovasc Dis. 2024 Apr 17;13:20480040241247396. doi: 10.1177/20480040241247396. eCollection 2024 Jan-Dec.
PubMed 38638397Guevara VLS, Coelho RF, Flores EP. Effects of dialogic reading for comprehension (LuDiCa) on the social interaction of autistic adolescents and their peers. Psicol Reflex Crit. 2024 Feb 2;37(1):4. doi: 10.1186/s41155-023-00283-x.
PubMed 38305847Na JY, Wilkinson KM. Communication about emotions during storybook reading: Effects of an instruction programme for children with Down syndrome. Int J Speech Lang Pathol. 2018 Dec;20(7):745-755. doi: 10.1080/17549507.2017.1356376. Epub 2017 Aug 7.
PubMed 28780903Munoz-Llerena A, Ladron-de-Guevara L, Medina-Rebollo D, Alcaraz-Rodriguez V. Impact of Physical Activity on Autonomy and Quality of Life in Individuals with Down Syndrome: A Systematic Review. Healthcare (Basel). 2024 Jan 11;12(2):181. doi: 10.3390/healthcare12020181.
PubMed 38255069Neitzel I. Narrative abilities in individuals with Down syndrome: single case-profiles. Front Psychol. 2023 Oct 3;14:1116567. doi: 10.3389/fpsyg.2023.1116567. eCollection 2023.
PubMed 37854146Alqahtani AS, Algabbani MF, Alhammad SA, Alwadeai KS, Alhusaini A. Physical activity status and its association with quality of life among children with down syndrome in Saudi Arabia: A comparative cross-sectional study. PLoS One. 2024 Feb 12;19(2):e0297111. doi: 10.1371/journal.pone.0297111. eCollection 2024.
PubMed 38346033
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06813625
- Acronym / sponsor ID
- HE-0442-2025
- Conditions
- Down Syndrome
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MacauUniversity, hospital or other
- Study start
- 8 Feb 2025 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shared book reading intervention | Experimental | Behavioral: Shared book reading interventionAn 8-week pilot binary randomized controlled trial involving one hour of shared book reading per week in young people with and without Down syndrome. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 2 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- -Have severe visual or reading disabilities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared book reading interventionThe 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. | Behavioural | Shared book reading intervention |
Primary outcome
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).
3 secondary outcomes
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Background: PubMed 39651467Perra A, Primavera D, Leonetti V, Montisci R, Carta D, Lorrai G, Locci A, Chessa L, Scuteri A, Cossu G, Nardi AE, Valmaggia L, Galetti A, De Lorenzo V, Sancassiani F, Carta MG. Virtual reality cognitive remediation tool for individuals with mild cognitive impairment: study protocol for a feasibility randomized clinical trial. Front Public Health. 2024 Nov 22;12:1477279. doi: 10.3389/fpubh.2024.1477279. eCollection 2024.
- Background: PubMed 38711768Peiris DLIHK, Duan Y, Vandelanotte C, Liang W, Baker JS. In-classroom physical activity breaks program among school children in Sri Lanka: study protocol for a randomized controlled trial. Front Public Health. 2024 Apr 22;12:1360210. doi: 10.3389/fpubh.2024.1360210. eCollection 2024.
- Background: PubMed 38644604Bridi D, Valentini NC, Deslandes AC, Copetti F. Focused attention and intrinsic motivation using animations for instruction of fundamental motor skills in children with Down syndrome. J Intellect Disabil Res. 2024 Aug;68(8):954-968. doi: 10.1111/jir.13140. Epub 2024 Apr 21.
- Background: PubMed 38928536Hsu CF, Jiang Q, Rao SY. Category-Based Effect on False Memory of People with Down Syndrome. Brain Sci. 2024 May 24;14(6):538. doi: 10.3390/brainsci14060538.
- Background: PubMed 37562321Grover V, Snow CE, Evans L, Stromme H. Overlooked advantages of interactive book reading in early childhood? A systematic review and research agenda. Acta Psychol (Amst). 2023 Sep;239:103997. doi: 10.1016/j.actpsy.2023.103997. Epub 2023 Aug 8.
- Background: PubMed 37546441Frizelle 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.
- Background: PubMed 39797957Dong 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.
- Background: PubMed 35686577Akkarakittichoke 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.
- Background: PubMed 35209927Wiwaha G, Sari DM, Biben V, Sunjaya DK, Hilmanto D. Translation and validation of Indonesian version of Pediatric Quality of Life Inventory (PedsQL) Neuromuscular Module. Health Qual Life Outcomes. 2022 Feb 24;20(1):33. doi: 10.1186/s12955-022-01933-x.
- Background: PubMed 38638397Kamdem F, Meyanga Ngoah J, Nganou Gnindjio CN, Mekoulou Ndongo J, Ba H, Mouliom S, Viche L, Ngote H, Kenmegne C, Tsague Kengni H, Ndom Ebongue MS, Djibrilla S, Bika Lele EC. Pattern and determinants of health-related quality of life of adolescents with congenital heart disease in Cameroon: A single-center cross-sectional study. JRSM Cardiovasc Dis. 2024 Apr 17;13:20480040241247396. doi: 10.1177/20480040241247396. eCollection 2024 Jan-Dec.
- Background: PubMed 38305847Guevara VLS, Coelho RF, Flores EP. Effects of dialogic reading for comprehension (LuDiCa) on the social interaction of autistic adolescents and their peers. Psicol Reflex Crit. 2024 Feb 2;37(1):4. doi: 10.1186/s41155-023-00283-x.
- Background: PubMed 28780903Na JY, Wilkinson KM. Communication about emotions during storybook reading: Effects of an instruction programme for children with Down syndrome. Int J Speech Lang Pathol. 2018 Dec;20(7):745-755. doi: 10.1080/17549507.2017.1356376. Epub 2017 Aug 7.
- Individual participant dataSharing planned: Undecided. 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.
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Down Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared book reading intervention in people with Down Syndrome, run by University of Macau at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06813625, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.