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.
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, 534 eligible adolescents age 13-19 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
636
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.
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.
UI Health
Chicago, Illinois, United States
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.
Time frame: 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."
Time frame: 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).
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: Baseline through 18 months
Blood Pressure
Measured in millimeters of mercury
Time frame: Baseline and 18 months
Body Mass Index
Calculated by measuring height (centimeters) and weight (kilogram) to calculate kg/meters squared (BMI, Body Mass Index)
Time frame: Baseline and 18 months
Weight
Measured in kilograms by standard medical office scale, fully clothed participant
Time frame: Baseline and 18 months
Height
Measure by standard medical office practice measure, without shoes, in centimeters
Time frame: 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.
Time frame: Baseline through 18 months
Implementation themes
Consolidated Framework for Implementation Research (CFIR) will be used to explore experience of the study from the perspective of 25 stakeholders
Time frame: 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).
Time frame: Baseline through 18 months
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