Clinical trial NCT04290754: PATH 2 Purpose: Primary Care and Community-Based Prevention of Mental Disorders in Adolescents
Official title: PATH 2 Purpose: Primary Care and Community-Based Prevention of Mental Disorders in Adolescents
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Keywords: Adolescents
Depression
Internet intervention
Cognitive-Behavioral Therapy
Prevention
Group Therapy
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: University of Illinois College of Medicine Rockford
name: Wake Forest University Health Sciences
name: Katherine Shaw Bethea Hospital
name: University of Louisville
name: Patient-Centered Outcomes Research Institute
name: Brown University
name: Mile Square Health Center
First posted: 2020-03-02
Enrollment: 636
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparative Effectiveness Study
Primary purpose: PREVENTION

Brief 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, 564 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.

Detailed description: The majority of mental, emotional and behavioral (MEB) disorders have an initial onset before age 24, with 20% annual incidence, with major depressive disorder (MDD) being the most common MEB. Health systems, eager to reduce costs, want to transition from the current "wait until sick enough for treatment" model for MDD to a preventive model. However, evidence is needed for (1) the comparative effectiveness of a "scalable intervention" and (2) an implementation model for such a scalable intervention in the primary care setting. This study is a comparative effectiveness trial evaluating the efficacy of two evidence-based cognitive-behavioral prevention (CBP) programs: Teens Achieving Mastery over Stress (TEAMS), the "gold standard," group therapy model, and Competent Adulthood Transition with Cognitive Behavioral, Humanistic and Interpersonal Training (CATCH-IT), a scalable, self-directed, technology-based model. For implementation during the COVID-19 pandemic, TEAMS has successfully been adapted to an online format and administered online through HIPAA-compliant video conferencing software. For the first cohort, 564 eligible adolescents age 13-18 will be offered one of two different depression prevention programs using cluster randomization in multiple sites in urban and suburban Chicago, Illinois; rural Western Illinois, including Dixon and surrounding towns; and Louisville, Kentucky. Randomization will be blocked into matched pairs of primary health care clinics and school sites and stratified by race, ethnicity, rural-urban commuting area codes, and socio-economic disadvantage using the Distressed Communities Index (DCI) from census-tracked data of each site zip code. A second cohort of 100 eligible adolescents will be recruited through public health media campaigns in Illinois, Kentucky, and Massachusetts utilizing the same eligibility criteria as Cohort One. These participants will connect with the research team by phone, email, web survey, or social media and will be randomized at the individual-level with equal allocation into treatment conditions (CATCH-IT or TEAMS). The investigators will comprehensively evaluate patient-centered outcomes and stakeholder-valued moderators of effect at 2, 6, 12, and 18 month assessment points. Using a hybrid clinical trial design that simultaneously examines implementation process, the study will also assess adolescents', parents' and providers' experiences (i.e. efficacy, time commitment, cultural acceptability, and implementation cost) with each intervention approach. A sub-sample of Cohort Two (n=50, 25 from each intervention arm) will be recruited to participate in open-ended interviews for adolescents to share their experiences of living with subsyndromal depression, coping during the COVID-19 pandemic, their perceived impact of CATCH-IT or TEAMS on their mood and behavior, and the cultural contexts in which these experiences occurred.

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

Primary outcomes:
measure: Time
timeFrame: Baseline through 18 months
measure: Cultural acceptability adolescent and family
timeFrame: Baseline through 18 months
measure: Cost
timeFrame: Baseline through 18 months
measure: Depressive and mental disorder episodes
timeFrame: Baseline through 18 months
measure: Stress symptoms
timeFrame: Baseline through 18 months
measure: Resiliency
timeFrame: Baseline through 18 months
measure: Function
timeFrame: Baseline through 18 months
measure: Relationships (Life Events)
timeFrame: Baseline through 18 months
measure: Socio-cultural Relevance
timeFrame: Baseline through 18 months
measure: Organizational Readiness to Change Assessment
timeFrame: Baseline
measure: Intervention Sustainability
timeFrame: end of study, 30 months
measure: Acceptability of Intervention
timeFrame: end of study, 30 months
measure: Feasibility of Intervention
timeFrame: end of study, 30 months
measure: Intervention Appropriateness
timeFrame: Baseline through 18 months
measure: Depressive Symptoms
timeFrame: Baseline through 18 months
measure: Externalizing Behavior Symptoms
timeFrame: Baseline through 18 months
measure: Anxiety Symptoms
timeFrame: Baseline through 18 months
measure: Substance Abuse Symptoms
timeFrame: Baseline through 18 months
measure: Post Traumatic Stress Disorder Symptoms
timeFrame: Baseline through 18 months
measure: Rumination
timeFrame: Baseline through 18 months
measure: Dysfunctional Attitudes
timeFrame: Baseline through 18 months
measure: Relationships-Family
timeFrame: Baseline through 18 months
measure: Blood Pressure
timeFrame: Baseline and 18 months
measure: Body Mass Index
timeFrame: Baseline and 18 months
measure: Weight
timeFrame: Baseline and 18 months
measure: Height
timeFrame: Baseline and 18 months
measure: Recruiting model and comparative effectiveness outcomes
timeFrame: Baseline through 18 months
Secondary outcomes:
measure: Implementation themes
timeFrame: End of study, 30 months
measure: Moderation of Covid-19 factors on comparative effectiveness outcomes
timeFrame: Baseline through 18 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: UI Health
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago, School of Medicine
name: Benjamin W Van Voorhees, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Wellesley College, Wellesley Centers for Women
name: Tracy RG Gladstone, PhD
role: PRINCIPAL_INVESTIGATOR
References: