Child DevelopmentNCT04037761
Shanghai Children's Health, Education and Lifestyle Evaluation, Preschool (the SCHEDULE-P Study)
An observational study of Child Development, run by Sijia Gu at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Child Development
- How many people
- 20,899 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2016to Dec 2030
- Phase
- Observational
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: A stratified random sample of children aged 3-4 from 9 levels kindergartens in 16 districts of Shanghai.
Who may be able to join
- All 3-year-old children entered into public kindergartens or private kindergartens in Shanghai since 2016.
Who cannot join
- Children entered into international kindergartens
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Fan Jiang, Ph.D., +86-18930830668, fanjiang@shsmu.edu.cn
About this study
Official title: 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.
- Conditions
- Child Development
- Keywords
- early child development, cohort study, education
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographics and Socioeconomic statue information
Including parent's education, family income, etc.
Measured: 2 weeks
Child Care Environment
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.
Measured: 2 weeks
Parent-child interaction
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.
Measured: 2 weeks
Child behavior assessment, Sleep Habits
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.
Measured: 2 weeks
Child behavior assessment, Screening Exposure
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.
Measured: 2 weeks
Early Child Development
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.
Measured: 2 weeks
Social-emotion
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start1 Sep 2016
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,899 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sijia Gu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sijia Gu, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037761
- Sponsor's protocol ID
- SCMCIRB-K2016022-01
- Status last verified
- Apr 2021
- First submitted
- 25 Jun 2019
- Last updated
- 8 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shanghai Children's Health, Education and Lifestyle Evaluation, Preschool (the SCHEDULE-P) Cohort Study
- ClinicalTrials.gov ID
- NCT04037761
- Acronym / sponsor ID
- SCMCIRB-K2016022-01
- Conditions
- Child Development
- Keywords
- early child development, cohort study, education
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,899 participants (estimated)
- Lead sponsor
- Sijia GuUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 30 Jul 2019 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- A stratified random sample of children aged 3-4 from 9 levels kindergartens in 16 districts of Shanghai.
Key inclusion criteria (1 listed)
- All 3-year-old children entered into public kindergartens or private kindergartens in Shanghai since 2016.
Key exclusion criteria (1 listed)
- Children entered into international kindergartens
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demographics and Socioeconomic statue information
Time frame: 2 weeks
Including parent's education, family income, etc.
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.
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.
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.
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.
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.
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.
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 8 Apr 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Development, run by Sijia Gu 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 1 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: looking for participants now, as of the sponsor's last update on 8 Apr 2021. 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?
Contact Fan Jiang (+86-18930830668, fanjiang@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographics and Socioeconomic statue information (time frame: 2 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.