PATH 2 Purpose: Primary Care and Community-Based Prevention of Mental Disorders in Adolescents

Study Overview
=================
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.

Official Title
-----------------
PATH 2 Purpose: Primary Care and Community-Based Prevention of Mental Disorders in Adolescents

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Behavioral: CATCH-IT
* Behavioral: TEAMS


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparative Effectiveness Study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CATCH-IT<br>Competent Adulthood Transition with Cognitive-behavioral & Interpersonal Training (CATCH-IT) is an internet-based depression prevention program that targets decreasing modifiable risk factors while enhancing protective factors in at-risk adolescents, and that includes a parent program. It has been shown to be safe, feasible, and efficacious. | Behavioral: CATCH-IT<br>* Competent Adulthood Transition with Cognitive-behavioral & Interpersonal Training (CATCH-IT) is an internet-based depression prevention program that targets decreasing modifiable risk factors while enhancing protective factors in at-risk adolescents, and that includes a parent program. It has been shown to be safe, feasible, and efficacious.<br>|
| Active Comparator: TEAMS<br>Teens Achieving Mastery over Stress (TEAMS) is an 8-session group depression prevention program teaching teens how to deal with stress and negative moods, and ways to manage low mood based on cognitive-behavioral therapy (CBT) principles and strategies. Efficacy has been demonstrated by several trials over time. | Behavioral: TEAMS<br>* Teens Achieving Mastery over Stress (TEAMS) is an 8-session group depression prevention program teaching teens how to deal with stress and negative moods, and ways to manage low mood based on cognitive behavioral therapy (CBT) principles and strategies. Efficacy has been demonstrated by several trials over time.<br>* Other names: Prevention of Depression (POD);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time | Time will be measured to nearest minute for all intervention related activities including initial screening, engagement phone calls, use of CATCH-IT, TEAMS group activities, including travel time to and from TEAMS groups. Time will be measured from adolescent, family, practice, community center, healthcare organization, health system perspective. For time that cannot be directly measured by study staff, the investigators will sample direct observation or questionnaires to capture time required for health system related activities such as screening and engagement. | Baseline through 18 months | 
| Cultural acceptability adolescent and family | Cultural acceptability for each stakeholder using appropriate, validated instruments. Adolescent and family: Usefulness, Satisfaction, and Ease Questionnaire (USE, 30 items, self-report, 7-point Likert scale, 30-210 score range, higher score indicates more acceptable). An example statement is: I would recommend this to a friend. | Baseline through 18 months | 
| Cost | Costs will be measured for all stakeholders. For practice, community center, healthcare organizations, health systems, cost will be measured to nearest dollar by converting time measures into employment related costs based on mean wages an benefits for staff at that occupational level. Adolescent and family costs will be measured by converting time into mean hourly wages and benefits for adolescent and family members involved in the project (based on mean wage for age and occupation). | Baseline through 18 months | 
| Depressive and mental disorder episodes | Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI Kid, self-report). This is a structured psychiatric interview administered by a trained staff member which uses stem questions and follow-ups to determine the presence of symptoms and date of onset. The staff member then determines if and when the symptoms developed an episode is present. Measure is either episode present or not and date of onset. | Baseline through 18 months | 
| Stress symptoms | Center for Epidemiological Studies-Depression Scale (CES-D, 20 items, self-report, measured in frequency, 0,not at all to 3, nearly every day in last week, 0-60 score range, higher score indicates more depressed) | Baseline through 18 months | 
| Resiliency | Resiliency will be measured across multiple domains. To assess resiliency in terms of coping skills, the Connor-Davidson Resilience Scale (CD-RISC, 10 items, self-report, 4 levels of response, 0-40 score range, higher score indicates better coping skills) | Baseline through 18 months | 
| Function | Social Adjustment Scale Self-Report (SAS-SR, 23-items, self-report, 5-point Likert scale, 23-115 score range, higher score indicates higher levels of social adjustment) administered to adolescents only. | Baseline through 18 months | 
| Relationships (Life Events) | University of California at Los Angeles (UCLA) Life Events Scale (19-items, self-report) administered to adolescents only. | Baseline through 18 months | 
| Socio-cultural Relevance | The Socio-Cultural Relevance Scale (10-item and 14-item versions, self-report, 5-point Likert scale, 10-40 or 14-56 score ranges, higher score indicates greater socio-cultural relevance) will assess perceived change and satisfaction with the intervention, component of cultural acceptability to adolescent) | Baseline through 18 months | 
| Organizational Readiness to Change Assessment | Organizational Readiness to Change Assessment (ORCA, 18 questions, 4 items per question, self-report, 5-point Likert scale, 18-90 score range, higher score indicates higher organizational readiness, component of cultural acceptability to practice, community center, healthcare organizations, health systems) | Baseline | 
| Intervention Sustainability | Program Sustainability Assessment Tool (PSAT, 8 questions, self-report 5 items per question, 7-point Likert scale, 8-56 score range, higher score indicates higher capacity for program sustainability, component of cultural acceptability to practice, community center, healthcare organizations, health systems) | end of study, 30 months | 
| Acceptability of Intervention | Acceptability of Intervention Measure (AIM, 1 question with 4 items, self-report, 5-point Likert scale, 1-5 score range, higher score indicates greater acceptability of intervention, to be completed by all staff and leadership, repeatedly, component of cultural acceptability to practice, community center, healthcare organizations, health systems) | end of study, 30 months | 
| Feasibility of Intervention | Feasibility of Intervention Measure (FIM, 1 question with 4 items, self-report, 5-point Likert scale, 1-5 score range, higher score indicates greater feasibility of intervention, to be completed by all staff and leadership, repeatedly, component of cultural acceptability to practice, community center, healthcare organizations, health systems) | end of study, 30 months | 
| Intervention Appropriateness | Intervention Appropriateness Measure (IAM, 1 question with 4 items, self-report, 5-point Likert scale, 1-5 score range, higher score indicates greater appropriateness of intervention, to be completed by all staff and leadership, repeatedly, component of cultural acceptability to practice, community center, healthcare organizations, health systems) | Baseline through 18 months | 
| Depressive Symptoms | Patient Health Questionnaire-Adolescent (PHQ-A, 9 items plus 4 follow-up items, self-report, 3-point Likert scale, 0-27 score range, higher score indicates more depression symptoms/severity) | Baseline through 18 months | 
| Externalizing Behavior Symptoms | Disruptive Behavior Disorders Rating Scale-Adolescent (DBD-A, 41-items, self-report, 4-point Likert scale, 0-123 score range, higher score indicates greater externalizing symptoms) | Baseline through 18 months | 
| Anxiety Symptoms | Screen for Child Anxiety Related Disorders (SCARED, 41-items, self-report, 3-point Likert scale, 0-82 score range, higher score indicates greater anxiety symptoms) | Baseline through 18 months | 
| Substance Abuse Symptoms | Car, Relax, Alone, Forget, Friends, Trouble substance use assessment (CRAFFT, 6 items, self-report, 2-point scale, 0-6 score range, higher score indicates greater substance abuse symptoms) | Baseline through 18 months | 
| Post Traumatic Stress Disorder Symptoms | Child Post Traumatic Symptoms Disorder Scale (24-items, self-report, 4-point Likert scale, 0-72 score range, higher score indicates greater PTSD symptom levels) | Baseline through 18 months | 
| Rumination | Tendency towards rumination will be assessed by the Children's Response Style Scale (CRSS, 10-items, self-report, 5-point Likert scale, 0-50 score range, higher score indicates greater rumination (more repeated negative thinking, less resilient, component of resiliency) | Baseline through 18 months | 
| Dysfunctional Attitudes | The Dysfunctional Attitude Scale (DAS, 9-item, self-report, 7-point Likert scale, 9-63 score range, higher score indicates more dysfunctional attitude, less resiliency, component of resiliency) | Baseline through 18 months | 
| Relationships-Family | Child Report of Parental Behavior Inventory (CRPBI, 30-item, self-report, 3-point Likert scale, 0-60 score range, higher scores indicate more positive parent child relationship). | Baseline through 18 months | 
| Blood Pressure | Measured in millimeters of mercury | Baseline and 18 months | 
| Body Mass Index | Calculated by measuring height (centimeters) and weight (kilogram) to calculate kg/meters squared (BMI, Body Mass Index) | Baseline and 18 months | 
| Weight | Measured in kilograms by standard medical office scale, fully clothed participant | Baseline and 18 months | 
| Height | Measure by standard medical office practice measure, without shoes, in centimeters | Baseline and 18 months | 
| Recruiting model and comparative effectiveness outcomes | With the addition of a second cohort to be recruited through a public health media campaign, we will compare results between groups in each arm, and between the two recruitment models. We will compare implementation and clinical outcomes in the same trial arm, but also across the two recruiting methods. | Baseline through 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implementation themes | Consolidated Framework for Implementation Research (CFIR) will be used to explore experience of the study from the perspective of 25 stakeholders | End of study, 30 months | 
| Moderation of Covid-19 factors on comparative effectiveness outcomes | We will examine factors related to the COVID-19 pandemic that may be moderators of study outcomes: (1) COVID-19-related behaviors and consequences (e.g. social distancing, sheltering-in-place, family illness and death), and (2) Social determinants of health (e.g. food insecurity, internet access, unemployment) in both cohorts using the Holliston at-Home Questionnaire (a 26-item, adolescent self-report, 5-point Likert scale, 0-150 score range, higher score indicates greater externalizing symptoms). | Baseline through 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adolescents, Depression, Internet intervention, Cognitive-Behavioral Therapy, Prevention, Group Therapy