Dallas, Texas 75235

  • Depression, Anxiety

Purpose:

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 must have the patient volume to be able to recruit up to 500 patients over the course of 14 months, and they will be required to work closely with 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).


Study summary:

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.


Criteria:

Inclusion Criteria: 1. Be 8 to 20 years of age; 2. 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; 3. 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); 4. Be able to speak English or Spanish sufficiently to understand the study procedures and provide written informed consent to participate in the study; 5. Be willing to dedicate appropriate time to complete scheduled study assessments and measures (both parent/LAR/guardian and youth). 6. Be able to provide a reliable means of contact. Exclusion Criteria: 1. Have an acute medical or psychological condition(s) that that would, in the judgment of the study medical clinician, make participation difficult or unsafe; 2. 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); 3. Have active psychotic symptoms resulting in altered mental status and inability to provide assent or requiring immediate attention and/or higher level of intervention; 4. Have a parent/LAR/guardian who is deemed cognitively unable to provide consent (if youth participant, aged 8-17).


NCT ID:

NCT04572321


Primary Contact:

Principal Investigator
Madhukar Trivedi, MD
University of Texas Southwestern Medical Center

Jennifer Hughes, PhD
Phone: 214-648-6677
Email: Jennifer.Hughes@UTSouthwestern.edu


Backup Contact:

Email: Afsaneh.Rezaeizadeh@UTSouthwestern.edu
Afsaneh Rezaeizadeh, MSW
Phone: 214-648-6147


Location Contact:

Dallas, Texas 75235
United States

Afsaneh Rezaeizadeh, MSW
Email: Afsaneh.Rezaeizadeh@UTSouthwestern.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 28, 2022

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