Shanghai Children's Health, Education and Lifestyle Evaluation, Preschool (the SCHEDULE-P Study)

Child Development Clinical Trial

Official title:

Shanghai Children's Health, Education and Lifestyle Evaluation, Preschool (the SCHEDULE-P) Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04037761
• Other study ID #: SCMCIRB-K2016022-01
• Status: Recruiting
• Start date: September 1, 2016
• Est. completion date: December 2030

Study information

• Verified date: April 2021
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Fan Jiang
• Phone: +86-18930830668
• Email: fanjiang[@]shsmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20899
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Development

Locations

Country	Name	City	State
China	Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Sijia Gu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographics and Socioeconomic statue information	Including parent's education, family income, etc.	2 weeks
Primary	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.	2 weeks
Primary	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.	2 weeks
Primary	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.	2 weeks
Primary	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.	2 weeks
Primary	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.	2 weeks
Primary	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.	2 weeks