DepressionNCT04063202
Development of a Predictive Index for Probable Depression Among Secondary School Students
An observational study of Depression and Stress, run by Chinese University of Hong Kong at 4 sites in Hong Kong.
Trial summary
The present study aims to develop a new predictive index to predict future depression of adolescents by using factors including individual, interpersonal and environmental. The index can be used to predict likelihood of students who are non-probable depression cases convert into probable depression cases. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Depression, Stress, Youth
- What is being tested?
- Observation
- How many people
- 4,799 participants
- Where
- 4 sitesHong Kong
- Study dates
- 30 Oct 2020to Aug 2023
- 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 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Out of the 18 districts in Hong Kong, nine randomly selected districts will select randomly two schools and while the rest nine will randomly select one school. Replacements of schools will be made upon refusals. Within the selected schools, all Secondary 1-4 students will be invited to join the study. Students will be asked to fill in baseline questionnaires in the absence of teachers in classroom settings.
Who may be able to join
- Secondary 1 (seventh year of formal education) to Secondary 4 Chinese students, who are studying local mainstream schools in Hong Kong.
- Able to read Chinese and speak either Cantonese or Mandarin.
Who cannot join
- Eligible students whose parents refuse to give consent to take part in the study.
Trial locations and contacts
4 sites in 1 country.
Hong Kong4 sites, 4 recruiting
- Recruiting
China Holiness Church Living Spirit College
Hong Kong
2958 9694
- Recruiting
Christian Alliance SW Chan Memorial College (Christian Alliance SW Chan Memorial Secondary School)
Hong Kong
2670 9229
- Recruiting
Ho Ngai College ( Sponsored By Sik Sik Yuen)
Hong Kong
2441 7100
- Recruiting
Kit Sam Lam Bing Yim Secondary Schoo
Hong Kong
2337 9594
About this study
Official title: A Longitudinal Study for Identifying Predictors of Incidence/Remission of Probable Depression and Developing a Predictive Index for Probable Depression Among Secondary School Students
The present study aims to develop a new predictive index to predict future depression of adolescents by using factors including individual, interpersonal and environmental. The index can be used to predict likelihood of students who are non-probable depression cases convert into probable depression cases. In addition, the investigators also test the factors of depression remission. It can hence be used in school setting to identify high-risk students, and provide them with secondary interventions that are designed by considering modifiable significant variables identified in this unique, large-scale, longitudinal study.
Read the detailed description
A 12-month longitudinal study will be conducted in secondary school settings.
The investigators will investigate incidence of probable depression (i.e., from non-depression, CESD<16, at baseline to probable depression, CESD≥16, at month 12) and remission of probable depression.
The investigators will investigate factors that can prospectively predict new cases/remission of probable depression, including both well-documented risk/protective factors and some under-examined but potentially important local factors (e.g. school/academic stress, psychological resilience). The relative importance of the risk/protective factors at different socio-ecological levels will be compared and their combined effect will be identified.
Based on the selected factors, the investigators will derive a new prediction index called the Adolescent Depression Prediction Index (ADPI) in a model building sample and test its performance in predicting incidence of depression in a validation sample among secondary school students in Hong Kong.
- Conditions
- Depression, Stress, Youth
- Being tested
- Observation
- Keywords
- Adolescent, Depression, Stress, Resilience
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
The anonymous structured questionnaire will be self-administered by the participating students in the absence of their teachers in class-room settings.
| Study group | Role | What they receive |
|---|---|---|
| Non-cases | Secondary school students (seventh to tenth years of education) without probable depression at baseline interview. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of probable depression
To examine the incidence of probable depression from non-depression (CESD<16) at baseline to probable depression (CESD>=16) at month 12.
Measured: 12 months
Adolescent Depression Prediction Index (ADPI)
To develop a new prediction index ADPI and test test its performance in predicting incidence of depression.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start30 Oct 2020
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 4,799 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Xue YANG, Chinese University of Hong Kong
- Investigators
- Xue Yang, PhD, Principal investigator, JC School of Public Health and Primary Care, Faculty of Medicine, CUHK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063202
- Sponsor's protocol ID
- HMRF16171001
- Status last verified
- Mar 2022
- First submitted
- 19 Aug 2019
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study for Identifying Predictors of Incidence/Remission of Probable Depression and Developing a Predictive Index for Probable Depression Among Secondary School Students
- ClinicalTrials.gov ID
- NCT04063202
- Acronym / sponsor ID
- HMRF16171001
- Conditions
- Depression, Stress, Youth
- Keywords
- Adolescent, Depression, Stress, Resilience
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,799 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 21 Aug 2019 (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.
The present study aims to develop a new predictive index to predict future depression of adolescents by using factors including individual, interpersonal and environmental. The index can be used to predict likelihood of students who are non-probable depression cases convert into probable depression cases. In addition, the investigators also test the factors of depression remission. It can hence be used in school setting to identify high-risk students, and provide them with secondary interventions that are designed by considering modifiable significant variables identified in this unique, large-scale, longitudinal study.
Detailed description
A 12-month longitudinal study will be conducted in secondary school settings.
The investigators will investigate incidence of probable depression (i.e., from non-depression, CESD<16, at baseline to probable depression, CESD≥16, at month 12) and remission of probable depression.
The investigators will investigate factors that can prospectively predict new cases/remission of probable depression, including both well-documented risk/protective factors and some under-examined but potentially important local factors (e.g. school/academic stress, psychological resilience). The relative importance of the risk/protective factors at different socio-ecological levels will be compared and their combined effect will be identified.
Based on the selected factors, the investigators will derive a new prediction index called the Adolescent Depression Prediction Index (ADPI) in a model building sample and test its performance in predicting incidence of depression in a validation sample among secondary school students in Hong Kong.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-cases | – | Other: ObservationSecondary school students (seventh to tenth years of education) without probable depression at baseline interview. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Out of the 18 districts in Hong Kong, nine randomly selected districts will select randomly two schools and while the rest nine will randomly select one school. Replacements of schools will be made upon refusals. Within the selected schools, all Secondary 1-4 students will be invited to join the study. Students will be asked to fill in baseline questionnaires in the absence of teachers in classroom settings.
Key inclusion criteria (2 listed)
- Secondary 1 (seventh year of formal education) to Secondary 4 Chinese students, who are studying local mainstream schools in Hong Kong.
- Able to read Chinese and speak either Cantonese or Mandarin.
Key exclusion criteria (1 listed)
- Eligible students whose parents refuse to give consent to take part in the study.
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 |
|---|---|---|
| ObservationThe anonymous structured questionnaire will be self-administered by the participating students in the absence of their teachers in class-room settings. | Other | Non-cases |
Primary outcome
Incidence of probable depression
Time frame: 12 months
To examine the incidence of probable depression from non-depression (CESD<16) at baseline to probable depression (CESD>=16) at month 12.
Adolescent Depression Prediction Index (ADPI)
Time frame: 12 months
To develop a new prediction index ADPI and test test its performance in predicting incidence of depression.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Xue Yang, PhD principal investigator
JC School of Public Health and Primary Care, Faculty of Medicine, CUHK
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Stress, run by Chinese University of Hong Kong at 4 sites in Hong Kong.
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 2 inclusion and 1 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 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Xue Yang, PhD (+852 2252 8740, sherryxueyang@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of probable depression (time frame: 12 months). The study lists 2 primary outcomes in all. 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 17 Mar 2022.