NCT04572321

Brief Summary

The objective of this study is to build the Texas Youth Depression and Suicide Research Network to support the development of a Network Participant Registry and characterization of systems and interventions to examine statewide population health outcomes. All 12-13 sites represented in the Texas Child Mental Health Care Consortium (https://www.utsystem.edu/pophealth/tcmhcc/) have been invited to participate in the Texas Youth Depression and Suicide Research Network as "Nodes." 12 Nodes have been selected for this project. Each Node has obtained support of senior institutional leadership including the department chair. Leadership from each Node provided input and edits in the study design process by committee, with a focus on the inclusion of the "end user" in design decisions. Nodes will work closely with the Network Hub leadership to recruit, monitor, and retain participants. This will require active engagement and sustained relationships with clinics within the academic medical center as well as clinics in the community (i.e., psychiatry, psychology, counselling).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
77mo left

Started Aug 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Aug 2020Sep 2032

Study Start

First participant enrolled

August 26, 2020

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 1, 2020

Completed
11.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2032

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2032

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

11.9 years

First QC Date

September 17, 2020

Last Update Submit

April 27, 2026

Conditions

Keywords

depressionsuicidesuicidal ideationsuicide attemptteenchilddepressive episodedepression in teens

Outcome Measures

Primary Outcomes (1)

  • Network participant registry

    A participant registry with population health outcomes for youth with depression and or suicidal ideation or behavior.

    10 years

Secondary Outcomes (1)

  • Predictive models

    10 years

Eligibility Criteria

Age8 Years - 20 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants between the ages of 8 - 20 year-olds who either have symptoms of depression, or have suicidal ideation and/or behavior, or are in treatment for depression.

You may qualify if:

  • Be 8 to 20 years of age;
  • Have a positive screen for depression (e.g., based on PHQ-2 (score ≥3) and/or PHQ-A of 10 or greater, OR positive for suicidal ideation or behavior (e.g., based on CHRT-SR or PHQ-A item 9); OR be in treatment for depression;
  • Be willing to provide consent/assent (parents/LAR/guardian or young adult participant, aged 18-20, must be willing to provide consent; youth, aged 8-17, must be willing to provide assent);
  • Be able to read, write and speak English or Spanish sufficiently to understand the study procedures and provide written informed consent to participate in the study;
  • Be willing to dedicate appropriate time to complete scheduled study assessments and measures (both parent/LAR/guardian and youth).
  • Be able to provide a reliable means of contact.

You may not qualify if:

  • Have an acute medical or psychological condition(s) that that would, in the judgment of the study medical clinician, make participation difficult or unsafe;
  • Have an acute medical or psychological condition(s) that would result in an inability to accurately complete study requirements (e.g., neurological conditions or significant neurodevelopmental concerns);
  • Have active psychotic symptoms resulting in altered mental status and inability to provide assent or requiring immediate attention and/or higher level of intervention;
  • Have a parent/LAR/guardian who is deemed cognitively unable to provide consent (if youth participant, aged 8-17).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

DepressionSuicideSuicidal IdeationSuicide, AttemptedDepressive DisorderAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSelf-Injurious BehaviorMood DisordersMental Disorders

Study Officials

  • Madhukar Trivedi, MD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 17, 2020

First Posted

October 1, 2020

Study Start

August 26, 2020

Primary Completion (Estimated)

August 1, 2032

Study Completion (Estimated)

September 1, 2032

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations