Youth Depression and Suicide Research Network

Depression Clinical Trial

— YDSRN  

Official title:

Youth Depression and Suicide Research Network

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04572321
• Other study ID #: STU-2020-0665
• Status: Recruiting
• Start date: August 26, 2020
• Est. completion date: September 2032

Study information

• Verified date: June 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Holli Slater, PhD
• Phone: 214/645-8795
• Email: holli.slater[@]utsouthwestern.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: September 2032
• Est. primary completion date: August 2032
• Gender: All
• Age group: 8 Years to 20 Years

Eligibility

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).

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Network participant registry	A participant registry with population health outcomes for youth with depression and or suicidal ideation or behavior.	10 years
Secondary	Predictive models	Develop predictive models for short and long term outcomes for youth with depression and or suicidal behavior.	10 years