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

March 4, 2020 updated by: Vivian SHI, University of Macau

Mental Health and Its Correlates Among Chinese Adolescents Exposed to the Novel Coronavirus Disease 2019: A Longitudinal Study Protocol

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

3428

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

10 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders 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.

Description

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

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

Cohorts and Interventions

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
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.
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.
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.
Exposed to the novel coronavirus disease 2019

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
15 Oct 2020 - 15 Nov 2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
15 Oct 2020 - 15 Nov 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 (Anticipated)

October 15, 2020

Primary Completion (Anticipated)

November 15, 2020

Study Completion (Anticipated)

March 15, 2022

Study Registration Dates

First Submitted

March 4, 2020

First Submitted That Met QC Criteria

March 4, 2020

First Posted (Actual)

March 9, 2020

Study Record Updates

Last Update Posted (Actual)

March 9, 2020

Last Update Submitted That Met QC Criteria

March 4, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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