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NCT04290754
PATH 2 Purpose: Primary Care and Community-Based Prevention of Mental Disorders in Adolescents
Conditions: Depression
Sex: All
Ages: 13 Years – 19 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 636
Sponsor: University of Illinois at Chicago
Location: UI Health Chicago Illinois
Summary
PATH (Promoting AdolescenT Health) 2 Purpose is a two-arm comparative effectiveness research trial to that will evaluate the ability of the interventions, Competent Adulthood Transition with Cognitive-behavioral \& Interpersonal Training (CATCH-IT) and Teens Achieving Mastery over Stress (TEAMS), to intervene early to prevent depressive illness and potentially other common mental health disorders. Using cluster randomization, 534 participants eligible for the study will be offered one of two different depression prevention programs in multiple sites in Chicagoland, Rockford, Illinois; Dixon, Illinois; and Louisville, Kentucky. In response to the Coronavirus Disease 2019 (COVID-19) pandemic, we will employ a public health media campaign to recruit a second cohort of 100 adolescents state-wide in Illinois, Kentucky, and Massachusetts individually randomized to either intervention. The study will also assess teens', parents' and providers' experiences with each intervention approach. Finally, we will examine the impact of the COVID-19 pandemic on adolescents at-risk for depression who are enrolled in our study.
Eligibility Criteria
Inclusion Criteria:
* Adolescents ages 13 through 19 years, and
* Adolescent must be experiencing an elevated level of depressive symptoms (Patient Health Questionnaire-9 Score = 5-18), and
* Adolescent will be included if they have a past, but not current history of depression.
Exclusion Criteria:
* Outside age range
* A current diagnosis of Major Depression
* Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) diagnosis of: schizophrenia, bipolar affective disorder, extreme current drug or alcohol abuse.
* Currently using medication therapy for depression, anxiety, or other internalizing disorders for less than 3 months.
* Currently engaged in individual treatment for a mood disorder
* Currently engaged in a cognitive-behavioral group or therapy
* Any past psychiatric hospitalizations
* Any past self-harm attempt with moderate or greater lethality
* Current suicidal thoughts
* Not willing to comply with the study protocol
* Not willing to participate in the TEAMS groups
* Not willing to be audio recorded during TEAMS groups (only for TEAMS clinics)
* Unable to complete the PHQ-9 screening due to cognitive or intellectual impairment
* Did not complete phone assessment with MINI Kid
* Parent/guardian has a cognitive or intellectual impairment.
* Participant Declined/Changed Mind/Uninterested in participating
Source: ClinicalTrials.gov (NCT04290754). StuddyBuddy aggregates publicly available trial information.