Development of a Predictive Index for Probable Depression Among Secondary School Students

March 16, 2022 updated by: Dr. Xue YANG, Chinese University of Hong Kong

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4799

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • China Holiness Church Living Spirit College
        • Contact:
          • Phone Number: 2958 9694
      • Hong Kong, Hong Kong
        • Recruiting
        • Christian Alliance SW Chan Memorial College (Christian Alliance SW Chan Memorial Secondary School)
        • Contact:
          • Phone Number: 2670 9229
      • Hong Kong, Hong Kong
        • Recruiting
        • Ho Ngai College ( Sponsored By Sik Sik Yuen)
        • Contact:
          • Phone Number: 2441 7100
      • Hong Kong, Hong Kong
        • Recruiting
        • Kit Sam Lam Bing Yim Secondary Schoo
        • Contact:
          • Phone Number: 2337 9594

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Eligible students whose parents refuse to give consent to take part in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Non-cases
Secondary school students (seventh to tenth years of education) without probable depression at baseline interview.
Other: Observation
The anonymous structured questionnaire will be self-administered by the participating students in the absence of their teachers in class-room settings.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HMRF16171001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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