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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
Sponsor:
Information provided by (Responsible Party):
Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center

Brief 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 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).

Condition or disease
Depression Suicide Suicidal Ideation Suicide, Attempted Depressive Disorder Depressive Symptoms Depressive Episode Depression and Suicide Depression, Teen Depression, Anxiety

Detailed 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, 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide




Primary Outcome Measures :
  1. network participant registry [ Time Frame: 14 months ]
    a participant registry with population health outcomes for youth with depression and or suicidal ideation or behavior


Secondary Outcome Measures :
  1. predictive models [ Time Frame: 14 months ]
    develop predictive models for short and long term outcomes for youth with depression and or suicidal behavior



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
participants between the ages of 8 - 20 year-olds who either have symptoms of depression, or have suicidal ideation and or behavior, or are in treatment for depression.
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 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 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 who is deemed cognitively unable to provide consent (if youth participant, aged 8-17).

Information from the National Library of Medicine

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


Contacts
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Contact: Jennifer Hughes, PhD 214-648-6677 Jennifer.Hughes@UTSouthwestern.edu
Contact: Afsaneh Rezaeizadeh, MSW 214-648-6147 Afsaneh.Rezaeizadeh@UTSouthwestern.edu

Locations
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United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75235
Contact: Maria Monastirsky, MSW    214-648-0174    Maria.Monastirsky@UTSouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Madhukar Trivedi, MD University of Texas Southwestern Medical Center
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Responsible Party: Madhukar H. Trivedi, MD, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04572321    
Other Study ID Numbers: STU-2020-0665
First Posted: October 1, 2020    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center:
depression
suicide
suicidal ideation
suicide attempt
teen
child
depressive episode
depression in teens
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Suicide
Suicidal Ideation
Suicide, Attempted
Behavioral Symptoms
Mood Disorders
Mental Disorders
Self-Injurious Behavior