NCT04299711

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,428

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

October 15, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
Last Updated

March 9, 2020

Status Verified

March 1, 2020

Enrollment Period

1 month

First QC Date

March 4, 2020

Last Update Submit

March 4, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • The prevalence and incidence changes of common mental disorders

    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 Outcomes (1)

  • Mental disorders and its' correlates

    15 Oct 2020 - 15 Nov 2020

Study Arms (4)

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

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

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

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

Interventions

Exposed to the novel coronavirus disease 2019

12-month follow-up18-month follow-up6-month follow-upBaseline

Eligibility Criteria

Age10 Years - 19 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • age range: 10-19;
  • full-time students in these targets high or middle schools;
  • nationality: China;
  • exposure context: COVID-19;
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 9, 2020

Study Start

October 15, 2020

Primary Completion

November 15, 2020

Study Completion

March 15, 2022

Last Updated

March 9, 2020

Record last verified: 2020-03