Clinical trial NCT04572321: Youth Depression and Suicide Research Network
Official title: Youth Depression and Suicide Research Network
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Depression
Suicide
Suicidal Ideation
Suicide, Attempted
Depressive Disorder
Depressive Symptoms
Depressive Episode
Depression and Suicide
Depression, Teen
Depression, Anxiety
Keywords: depression
suicide
suicidal ideation
suicide attempt
teen
child
depressive episode
depression in teens
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 5000
Sex: ALL
Minimum age (years): 8
Maximum age (years): 20
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 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).

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 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.

Visit Schedule: Screening, Baseline, 13 Follow-Up Visits (5 assessment visits with self-reports, and 8 self-report visits only) during the first two years. Four Follow-Up Visits each year in Year 3 through Year 10 (1 assessment visit with self-report and 3 self-report visits only). All visits may be conducted remotely or in person.

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 Self Report (CHRT)-SR.

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, sex, 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.

Eligibility 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/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 read, write and 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).

Primary outcomes:
measure: Network participant registry
timeFrame: 10 years
Secondary outcomes:
measure: Predictive models
timeFrame: 10 years
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Madhukar Trivedi, MD
role: PRINCIPAL_INVESTIGATOR
References: