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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04037761
Recruitment Status : Recruiting
First Posted : July 30, 2019
Last Update Posted : July 30, 2019
Information provided by (Responsible Party):
Sijia Gu, Shanghai Jiao Tong University School of Medicine

Brief 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.

Condition or disease
Child Development

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Study Type : Observational
Estimated Enrollment : 20899 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Shanghai Children's Health, Education and Lifestyle Evaluation, Preschool (the SCHEDULE-P) Cohort Study
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Demographics and Socioeconomic statue information [ Time Frame: 2 weeks ]
    Including parent's education, family income, etc.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
A stratified random sample of children aged 3-4 from 9 levels kindergartens in 16 districts of Shanghai.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04037761

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Contact: Fan Jiang +86-18930830668
Contact: Yunting Zhang +86-18930830698

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China, Shanghai
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200127
Contact: Fan Jiang, Ph.D.    +86-18930830668   
Sponsors and Collaborators
Sijia Gu

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Responsible Party: Sijia Gu, Responsible Party, Clinical Research, Shanghai Jiao Tong University School of Medicine Identifier: NCT04037761     History of Changes
Other Study ID Numbers: SCMCIRB-K2016022-01
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sijia Gu, Shanghai Jiao Tong University School of Medicine:
early child development
cohort study