Youth Depression and Suicide Research Network
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 5,000
- 试验地点
- 2
- 主要终点
- Network participant registry
研究概览
简要总结
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).
详细描述
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 at the time of enrollment;
- 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 read, write and 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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/guardian 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 read, write and 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/guardian and youth).
- •Be able to provide a reliable means of contact.
排除标准
- •Have an acute medical or psychological condition(s) that that would, in the judgment of the study medical clinician, make participation difficult or unsafe;
- •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);
- •Have active psychotic symptoms resulting in altered mental status and inability to provide assent or requiring immediate attention and/or higher level of intervention;
- •Have a parent/LAR/guardian who is deemed cognitively unable to provide consent (if youth participant, aged 8-17).
结局指标
主要结局
Network participant registry
时间窗: 10 years
A participant registry with population health outcomes for youth with depression and or suicidal ideation or behavior.
次要结局
- Predictive models(10 years)
研究者
Madhukar H. Trivedi, MD
Professor
University of Texas Southwestern Medical Center