- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04299711
Mental Health and Its Correlates Among Chinese Adolescents Exposed to the Novel Coronavirus Disease 2019
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Study Plan
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
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SW888999
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Mental Disorder
-
Vincent AgyapongNova Scotia Health Authority; Dalhousie UniversityRecruitingGeneralized Anxiety Disorder | Major Depressive Disorder | Mental Health Wellness 1Canada
-
Otsuka Pharmaceutical Development & Commercialization...CompletedSchizophrenia | Major Depressive Disorder | Mental Disorder | Bipolar I DisorderUnited States
-
Brigham and Women's HospitalActive, not recruitingDepression | Mood Disorders | Depressive Disorder, Major | Psychiatric Disorder | Mental DisorderUnited States
-
Queen's UniversityCompleted
-
University of ManchesterRecruitingADHD | Mental Health | Autism | Neurodevelopment | Depression - Major Depressive Disorder | Anxiety Disorder (Panic Disorder or GAD)United Kingdom
-
Samsung Medical CenterUnknownMajor Depressive Disorder, Anxiety DisorderKorea, Republic of
-
York UniversityCentre for Addiction and Mental HealthSuspendedDisorder, Major DepressiveCanada
-
University of OuluCompletedSeasonal Affective Disorder (SAD)Finland
-
Massachusetts General HospitalSamsung ElectronicsActive, not recruitingMood Disorders | Major Depressive Disorder | Mental Health IssueUnited States
-
University of ChicagoUsona InstituteCompletedMajor Depressive Disorder | Borderline Personality DisorderUnited States
Clinical Trials on Exposed to the novel coronavirus disease 2019
-
Tongji HospitalUnknownCoronavirus Disease 2019China
-
Institut National de la Santé Et de la Recherche...CompletedCoronavirusFrance, French Guiana
-
Javier EslavaCompletedCOVID-19 | Long COVID | Post-acute COVID-19 Syndrome | Long-COVID | Post-acute Sequelae of SARS-CoV-2 InfectionColombia
-
Kaohsiung Kai-Suan Psychiatric HospitalNot yet recruitingThe Psychological Impact of COVID-19
-
Samsung Medical CenterCompletedThe Lamina Cribrosa and Optic Nerve Head Changes
-
Fresenius KabiRecruitingMalnutrition | Malnutrition, Child | Parenteral Nutrition Associated Cholestasis | Essential Fatty Acid Deficiency (EFAD)United States
-
Turku University HospitalUniversity of TurkuRecruitingMyocardial Infarction | Myocardial IschemiaFinland
-
Simon AnnaheimUniversity Children's Hospital, ZurichCompletedSkin Abnormalities | Skin; Injury, Superficial | Skin; Ulcer, DecubitusSwitzerland
-
University of British ColumbiaCompletedChronic Obstructive Lung DiseaseCanada
-
University of Southern CaliforniaCompletedCystic FibrosisUnited States