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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04299711
Other study ID # SW888999
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 15, 2020
Est. completion date March 15, 2022

Study information

Verified date March 2020
Source University of Macau
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 3428
Est. completion date March 15, 2022
Est. primary completion date November 15, 2020
Accepts healthy volunteers
Gender All
Age group 10 Years to 19 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Exposed to the novel coronavirus disease 2019
Exposed to the novel coronavirus disease 2019

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Macau

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Mental disorders and its' correlates 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
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