Youth Depression and Suicide Research Network (YDSRN)
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|ClinicalTrials.gov Identifier: NCT04572321|
Recruitment Status : Recruiting
First Posted : October 1, 2020
Last Update Posted : October 1, 2020
|Condition or disease|
|Depression Suicide Suicidal Ideation Suicide, Attempted Depressive Disorder Depressive Symptoms Depressive Episode Depression and Suicide Depression, Teen Depression, Anxiety|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||5000 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||Youth Depression and Suicide Research Network|
|Actual Study Start Date :||August 26, 2020|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||September 2021|
- network participant registry [ Time Frame: 14 months ]a participant registry with population health outcomes for youth with depression and or suicidal ideation or behavior
- predictive models [ Time Frame: 14 months ]develop predictive models for short and long term outcomes for youth with depression and or suicidal behavior
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04572321
|Contact: Jennifer Hughes, PhD||214-648-6677||Jennifer.Hughes@UTSouthwestern.edu|
|Contact: Afsaneh Rezaeizadeh, MSW||214-648-6147||Afsaneh.Rezaeizadeh@UTSouthwestern.edu|
|United States, Texas|
|UT Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75235|
|Contact: Maria Monastirsky, MSW 214-648-0174 Maria.Monastirsky@UTSouthwestern.edu|
|Principal Investigator:||Madhukar Trivedi, MD||University of Texas Southwestern Medical Center|