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Mental Health and Its Correlates Among Chinese Adolescents Exposed to the Novel Coronavirus Disease 2019

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ClinicalTrials.gov Identifier: NCT04299711
Recruitment Status : Not yet recruiting
First Posted : March 9, 2020
Last Update Posted : March 9, 2020
Sponsor:
Information provided by (Responsible Party):
Vivian SHI, University of Macau

Study Description
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Brief Summary:

Background: Direct exposure to public health emergencies is associated with increased mental disorders. It is less clear about the prevalence of common mental disorders and its correlates in Chinese adolescents after experiencing public health emergencies.

Objective: This longitudinal study aims to estimate the prevalence of common mental disorders (i.e. depression, anxiety, and post-traumatic stress disorder) and its correlates in a sample of Chinese adolescents after experience a public health emergency, namely the novel coronavirus disease 2019 (COVID-19).

Method: This study intends to recruit 3,428 Chinese adolescent students from high and middle schools in the baseline survey. This study will track these recruited participants every 6 months via three-wave follow-up (i.e. 6-month, 12-month, and 18-month follow-ups). The demographics (e.g. age, gender, education, family background, and residence) and psychosocial factors (i.e. exposure to traumatic events, religious belief, social media exposure, loneliness, and perceived social support) associated with common mental disorders (i.e. depression, anxiety, and post-traumatic stress disorder) will be investigated in this sample population. Furthermore, a hardcopy self-report questionnaire will be disturbed to all participants. Additionally, the cross-sectional analyses will be first conducted to estimate the prevalence of mental disorders and their correlates in data of baseline survey. After obtaining the longitudinal data, the relative risk, incident rate ratios, latent class analysis, and structural equation model may be performed in this study. Missing data will be solved by the multiple imputations. Data analysis tools included the Stata 16.0 and Mplus 8.4.

Discussion: This longitudinal study will better help to understand the prevalence changes of mental disorders among Chinese adolescents following the COVID-19. These findings have the potential to provide empirical evidence about the burden of mental disease and key drivers of Chinese adolescents following the COVID-19, which can benefit the formation of public policy and mental health intervention programming. This study will close the gaps that a lack of epidemiological studies about the mental disorder prevalence and related risk factors.


Condition or disease Intervention/treatment
Mental Disorder Other: Exposed to the novel coronavirus disease 2019

Study Design
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Study Type : Observational
Estimated Enrollment : 3428 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Mental Health and Its Correlates Among Chinese Adolescents Exposed to the Novel Coronavirus Disease 2019: A Longitudinal Study Protocol
Estimated Study Start Date : October 15, 2020
Estimated Primary Completion Date : November 15, 2020
Estimated Study Completion Date : March 15, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Baseline
This study intends to recruit 3,428 Chinese adolescent students exposed to the novel coronavirus disease 2019 in the baseline survey
 Other: Exposed to the novel coronavirus disease 2019
Exposed to the novel coronavirus disease 2019
6-month follow-up
This study will track the mental health status among these recruited 3,428 participants exposed to the novel coronavirus disease 2019 in the 6 follow-up study.
 Other: Exposed to the novel coronavirus disease 2019
Exposed to the novel coronavirus disease 2019
12-month follow-up
This study will track the mental health status among these recruited 3,428 participants exposed to the novel coronavirus disease 2019 in the 12 follow-up study.
 Other: Exposed to the novel coronavirus disease 2019
Exposed to the novel coronavirus disease 2019
18-month follow-up
This study will track the mental health status among these recruited 3,428 participants exposed to the novel coronavirus disease 2019 in the 18 follow-up study.
 Other: Exposed to the novel coronavirus disease 2019
Exposed to the novel coronavirus disease 2019


Outcome Measures
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Primary Outcome Measures :
  1. The prevalence and incidence changes of common mental disorders [ Time Frame: 15 Oct 2020 - 15 Nov 2020 ]
    The prevalence and incidence changes of common mental disorders (i.e. depression, anxiety, and PTSD) in a representative sample of Chinese adolescents


Secondary Outcome Measures :
  1. Mental disorders and its' correlates [ Time Frame: 15 Oct 2020 - 15 Nov 2020 ]
    To identify demographics (e.g. age, gender, education, family background, and residence) the major psychosocial factors (i.e. exposure to traumatic events, religious belief, social media exposure, loneliness, and perceived social support) contributing to prevalence and incidence of mental disorders


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
The study will be conducted in Yibin City, Sichuan province, China. A total of six schools (two high schools and four middle schools) will be contacted for the data collection. According to the formula for the finite population for prevalence studies and the attrition rate of the cohort study, the total number of estimated sample size is 3,428, which will be recruited in the baseline study.
Criteria

Inclusion Criteria:

  1. age range: 10-19;
  2. full-time students in these targets high or middle schools;
  3. nationality: China;
  4. exposure context: COVID-19;
  5. able to adequately understand the content of consent form and questionnaire;

(d) able to sufficiently state the purpose of the research and acknowledge the potential risks and benefits based on the questionnaire

Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Vivian SHI, Dr., University of Macau
ClinicalTrials.gov Identifier: NCT04299711    
Other Study ID Numbers: SW888999
First Posted: March 9, 2020    Key Record Dates
Last Update Posted: March 9, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mental Disorders