Mental DisorderNCT04299711
Mental Health and Its Correlates Among Chinese Adolescents Exposed to the Novel Coronavirus Disease 2019
An observational study of Mental Disorder, run by University of Macau.
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. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Mental Disorder
- What is being tested?
- Exposed to the novel coronavirus disease 2019
- How many people
- 3,428 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2020to 15 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- Child, Adult
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.
Who may be able to join
- 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;
- able to sufficiently state the purpose of the research and acknowledge the potential risks and benefits based on the questionnaire
Who cannot join
None listed.
About this study
Official title: 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).
Read more
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.
- Conditions
- Mental Disorder
- Being tested
- Exposed to the novel coronavirus disease 2019
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposed to the novel coronavirus disease 2019Other
Exposed to the novel coronavirus disease 2019
| Study group | Role | What they receive |
|---|---|---|
| Baseline | This study intends to recruit 3,428 Chinese adolescent students exposed to the novel coronavirus disease 2019 in the baseline survey Receives: 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. Receives: 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. Receives: 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. Receives: Other: Exposed to the novel coronavirus disease 2019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 Oct 2020 - 15 Nov 2020
Secondary outcomes (1)
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
Measured: 15 Oct 2020 - 15 Nov 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start15 Oct 2020 (estimated)
- Primary completion15 Nov 2020 (estimated)
- Study completion15 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,428 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Macau
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vivian SHI, University of Macau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299711
- Sponsor's protocol ID
- SW888999
- Status last verified
- Mar 2020
- First submitted
- 4 Mar 2020
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health and Its Correlates Among Chinese Adolescents Exposed to the Novel Coronavirus Disease 2019: A Longitudinal Study Protocol
- ClinicalTrials.gov ID
- NCT04299711
- Acronym / sponsor ID
- SW888999
- Conditions
- Mental Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,428 participants (estimated)
- Lead sponsor
- University of MacauUniversity, hospital or other
- Study start
- 15 Oct 2020 (estimated)
- Primary completion
- 15 Nov 2020 (estimated)
- Study completion
- 15 Mar 2022 (estimated)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Baseline | – | Other: Exposed to the novel coronavirus disease 2019This study intends to recruit 3,428 Chinese adolescent students exposed to the novel coronavirus disease 2019 in the baseline survey |
| 6-month follow-up | – | Other: Exposed to the novel coronavirus disease 2019This 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. |
| 12-month follow-up | – | Other: Exposed to the novel coronavirus disease 2019This 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. |
| 18-month follow-up | – | Other: Exposed to the novel coronavirus disease 2019This 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. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposed to the novel coronavirus disease 2019Exposed to the novel coronavirus disease 2019 | Other | 12-month follow-up, 18-month follow-up, 6-month follow-up, Baseline |
Primary outcome
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
1 secondary outcome
Mental disorders and its' correlates
Time frame: 15 Oct 2020 - 15 Nov 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Disorder, run by University of Macau.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence and incidence changes of common mental disorders (time frame: 15 Oct 2020 - 15 Nov 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.