Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Depression
  • Depression and Suicide
  • Depression, Anxiety
  • Depression, Teen
  • Depressive Disorder
  • Depressive Episode
  • Depressive Symptoms
  • Suicidal Ideation
  • Suicide
  • Suicide, Attempted
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 8 years and 20 years
Gender
Both males and females

Description

Objective: 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. Methodology: Youth patients of participating clinics (ages 8-20)...

Objective: 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. Methodology: Youth patients of participating clinics (ages 8-20) and their parents will be recruited for participation in the Network Participant Registry Study. Upon informed consent/assent, baseline data will be collected regarding mood symptoms, suicidal ideation and behavior, associated comorbidities, treatment history, services use, and social determinants of health. Youth participants and parents will be sent monthly measures through the Electronic Data Capture (EDC) system developed and maintained by UT Southwestern. Additionally, measures will be given at provider visits to support delivery of measurement-based care within the clinics. Number of Participants: 5000 Participants and/or Coupled Participants (coupled-Parent and Youth) Criteria for Inclusion: This study will enroll youth with depression and/or suicidal ideation. and meet all of the following criteria: 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 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 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 and youth). Be able to provide a reliable means of contact. Visit Schedule: Screening Visit, Baseline, 6 Follow-Up Visits (2 of which are In-Person, and 4 of which are Remote), and Final Visit. Duration of study is approximately 12-13 months; some visits will be conducted remotely. Outcome Measures: Multiple streams of outcome measures will be utilized for this protocol, including self-report and parent-report measures, research assessor-completed measures, clinic level measures, and data obtained through chart review from the EHR. Safety and Tolerability Measures: Adverse event (AE) recording, 9 item Patient Health Questionnaire (PHQ-A), Concise Health Risk Tracking (CHRT)-SR, and Self-Report. Statistical Justification: The goals of the statistical analyses includes the following: To provide a descriptive summary of the data by participating network nodes as well as by various socio-demographic characteristics of the participants such as age groups, gender (as a biological variable), urban or rural, degree of fidelity to MBC, etc. To build predictive models for treatment outcomes and trajectories of disease course as well as models to assist with treatment selection that may benefit subgroups of participants.

Tracking Information

NCT #
NCT04572321
Collaborators
Not Provided
Investigators
Principal Investigator: Madhukar Trivedi, MD University of Texas Southwestern Medical Center