Youth Depression and Suicide Research Network — YDSRN  

Depression Clinical Trial

Official title: Youth Depression and Suicide Research Network

Status Recruiting

Clinical Trial 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).

Clinical Trial 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) 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, a Baseline Visit, 13 Follow-Up Visits during the first 2 years, and 32 Follow-up Visits for Year 3 through Year 10. Visits may occur in-person or by phone/video conference. Duration of study is approximately 10 years.

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. ;

Related Conditions & MeSH terms

• Depression
• Depression and Suicide
• Depression, Anxiety
• Depression, Teen
• Depressive Disorder
• Depressive Episode
• Depressive Symptoms
• Suicidal Ideation
• Suicide
• Suicide, Attempted

• NCT number: NCT04572321
• Study type: Observational [Patient Registry]
• Source: University of Texas Southwestern Medical Center
• Contact: Holli Slater, PhD
• Phone: 214/645-8795
• Email: holli.slater@utsouthwestern.edu
• Status: Recruiting
• Start date: August 26, 2020
• Completion date: September 2032