- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04037761
Shanghai Children's Health, Education and Lifestyle Evaluation, Preschool (the SCHEDULE-P Study)
April 5, 2021 updated by: Sijia Gu
Shanghai Children's Health, Education and Lifestyle Evaluation, Preschool (the SCHEDULE-P) Cohort Study
Shanghai is one of pilot areas for the early education of 3-6 years old infants in China.
Shanghai Municipal Education Commission has been actively exploring more effective early education guidance methods.
This survey, in the form of online questionnaire and site test, aims to dynamically evaluate the changes in the early development level of children in Shanghai and provide scientific basis for providing better early education services in the future.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
20899
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fan Jiang
- Phone Number: +86-18930830668
- Email: fanjiang@shsmu.edu.cn
Study Contact Backup
- Name: Yunting Zhang
- Phone Number: +86-18930830698
- Email: edwinazhang@hotmail.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200127
- Recruiting
- Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
-
Contact:
- Fan Jiang, Ph.D.
- Phone Number: +86-18930830668
- Email: fanjiang@shsmu.edu.cn
-
-
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
3 years to 6 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
A stratified random sample of children aged 3-4 from 9 levels kindergartens in 16 districts of Shanghai.
Description
Inclusion Criteria:
- All 3-year-old children entered into public kindergartens or private kindergartens in Shanghai since 2016.
Exclusion Criteria:
- Children entered into international kindergartens
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demographics and Socioeconomic statue information
Time Frame: 2 weeks
|
Including parent's education, family income, etc.
|
2 weeks
|
Child Care Environment
Time Frame: 2 weeks
|
The ICCE measures child care environment through 13 questions in four subscales: "human stimulation" , "social stimulation", "avoidance of restriction", and "social support".
It can be used as a self-report or interview, meaning that it does not necessarily need a home visit.
Each item is assessed using a multiple-choice format, and the answer is given a binary score according to the manual (1 = good, 0 = not good or not sure); the overall score is calculated by summing all items in the scale.
A higher score indicates a better child care environment.
|
2 weeks
|
Parent-child interaction
Time Frame: 2 weeks
|
Chinese parent-child interaction scale (CPCIS): Parent-child interaction was assessed using the Chinese Parent-Child Interaction Scale, a standardized questionnaire, which has been well-validated using Rasch analysis.
It has also been shown to have good person-separation reliability (0.82).
Parents were asked to indicate the frequency of 12 parent-child interactive activities they engaged in during the past month on a scale of 0-5 (0 = not occurring, 5 = very frequent).
The questionnaire measures the quantity of the most common activities of learning related, reading, recreation, and interaction with environment.
The total scores added from all activities were used in the analysis.
|
2 weeks
|
Child behavior assessment, Sleep Habits
Time Frame: 2 weeks
|
Children's Sleep Habits Questionnaire (CHSQ) Sleep onset and wake up time in the past weekdays and weekends were collected from a parent reported Children Sleep Habits Questionnaire23 and sleep duration in weekdays and weekends was calculated separately.
Daily average sleep duration was calculated using the formula: ([weekday sleep duration×5] + [weekend sleep duration×2])/7.
|
2 weeks
|
Child behavior assessment, Screening Exposure
Time Frame: 2 weeks
|
Parents according to the situation of children over the past month, respectively report children's school day and rest every day to watch quiz and educational video programs, entertainment, the children watch every day and educational video programs, entertainment, the children every day to watch video programs, entertainment, the children's television, playing video games, and playing video games and browsing the web time.
|
2 weeks
|
Early Child Development
Time Frame: 2 weeks
|
We perform Early Human Capability Index (eHCI) to evaluate early childhood development in 3-5-year-olds that predicts future capabilities.
It covers general verbal communication, approaches to learning, numeracy and concepts, formal literacy-reading and writing, cultural knowledge, social and emotional skills, perseverance, and physical health of child development.
For each domain, the scores range from 0 through to 1, with 1 being the best score and 0 the worst.
|
2 weeks
|
Social-emotion
Time Frame: 2 weeks
|
The Strengths and Difficulties Questionnaire (SDQ) we use in this survey is a short screening questionnaire covering the current difficulties in social psychology (i.e.
emotional symptoms, conduct problems, hyperactivity-inattention, peer problems), and personal strengths (i.e.
prosocial behavior).
High SDQ score is associated with an increase in psychiatric risk, on the opposite, prosocial behavior score is positive with prosocial behavior.
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (ACTUAL)
September 1, 2016
Primary Completion (ANTICIPATED)
December 1, 2030
Study Completion (ANTICIPATED)
December 1, 2030
Study Registration Dates
First Submitted
June 25, 2019
First Submitted That Met QC Criteria
July 28, 2019
First Posted (ACTUAL)
July 30, 2019
Study Record Updates
Last Update Posted (ACTUAL)
April 8, 2021
Last Update Submitted That Met QC Criteria
April 5, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SCMCIRB-K2016022-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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