The PATHway Study: Primary Care Based Depression Prevention in Adolescents

Study Overview
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Brief Summary
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Prevention of depressive disorders has become a key priority for the NIMH, but the investigators have no widely available public health strategy to reduce morbidity and mortality. To address this need, the investigators developed and evaluated the primary care based-technology behavioral vaccine, Competent Adulthood Transition with Cognitive-Behavioral Humanistic and Interpersonal Therapy (CATCH-IT). The investigators will engage N=4 health systems representative of the United States health care system, and conduct a factorial design study to optimize the intervention in preparation for an implementation study and eventual dissemination.

Detailed Description
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With more than 13% of adolescents diagnosed with depressive disorders each year, prevention of depressive disorders has become a key priority for the National Institute of Mental Health (NIMH). Unfortunately, the investigators have no widely available interventions to reduce morbidity and mortality (e.g. public health impact). To address this need, the investigators developed a multi-health system collaboratory to develop and evaluate the primary care based technology behavioral vaccine, Competent Adulthood Transition with Cognitive-Behavioral Humanistic and Interpersonal Therapy (CATCH-IT) (14 adolescent, 5 parent modules). Using this health-system collaboratory model, the full CATCH-IT program (all modules), demonstrated evidence of efficacy in prevention of depressive episodes in phase-three clinical trials in the United States and China. However, like many package interventions, CATCH-IT became larger and more complex across efficacy trials. Thus, adolescents were less willing to complete all 14 modules, suggesting adolescent dose tolerability issues (e.g., satisfaction, acceptability and resource use, time as cost). Similarly, primary care practices have scalability challenges (acceptability, feasibility, resource use, cost), resulting in declining REACH (percent of at-risk youth who complete intervention). To prepare for implementation studies and dissemination, the investigators need to address adolescent tolerability and practice/health system scalability, while preserving efficacy. Multiphase Optimization Strategy (MOST) uses a systematic analytic approach and a factorial randomized clinical trial design to address efficacy, tolerability, and scalability, simultaneously. The investigators will use a MOST approach to optimize CATCH-IT for the prevention of depression (indicated prevention, i.e., elevated symptoms of depression) in practices and health systems representative of US geography and population. The theoretically grounded components of CATCH-IT selected for study and optimization include: behavioral activation, cognitive-behavioral therapy, interpersonal psychotherapy, and parent program. The investigators will use a 4-factor (2x2x2x2) fully crossed factorial design with N=16 cells (25 per cell, 15% dropout) to evaluate the contribution of each component. The investigators propose to randomize N=400 adolescents from multiple sites: Advocate-Aurora Health Care (n=200); Lurie Children's Hospital (n=70); NorthShore University HealthSystem (n=70); University of Chicago Comer Hospital (n=25); University of Texas (n=20); University of Illinois College of Medicine Peoria (n=15). The at-risk youth will be high school students 13 through 18 years old, not currently experiencing a mood disorder, but with subsyndromal symptoms of depression (moderate to high risk). Using the efficient factorial design, the investigators can assess the contribution to prevention efficacy of each component. Thus, the MOST study design will enable us to eliminate non-contributing components while preserving efficacy and to optimize CATCH-IT by strengthening tolerability and scalability by reducing resource use. By reducing resource use, the investigators anticipate satisfaction and acceptability will also increase, preparing the way for an implementation trial and eventual US Preventive Services Task Force endorsement to support dissemination. Thus, the primary question is whether one component, or perhaps two, can demonstrate an equivalent effect to combinations of other components in terms of efficacy, whilst also demonstrating superior adolescent/family tolerability scalability over a 12-month follow-up.

Official Title
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Primary Care Based Depression Prevention in Adolescents: Intervention Optimization in Preparation for Implementation Study

Conditions
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Depression, Mental Disorder in Adolescence

Intervention / Treatment
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* Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adolescents ages 13 through 18 years, and Adolescents must be experiencing an elevated level of depressive symptoms (PHQ-9 = 5-18), and Adolescents will be included if they have had past depressive episode/s, but not if they are in a current depressive episode. Exclusion Criteria: Outside age range: 12 or younger 19 or older Adolescent is a non-English speaker/reader On the PHQ-9 screening, depression symptom level is: PHQ-9 = 4 or lower PHQ-9 =19 or higher As assessed by the MINI Kid, a current depressive episode As assessed by the MINI Kid, adolescent meets DSM-5 criteria for a psychotic or bipolar disorder. Currently using medication therapy for depression, anxiety, or other internalizing disorders. Currently engaged in individual treatment for a mood disorder (assessed by BCC during phone screen) Currently engaged in a cognitive-behavioral group or therapy (assessed by BCC during phone screen) Any past psychiatric hospitalizations Any past suicide attempt or incident of self-harm with moderate or greater lethality Extreme, current drug/alcohol abuse (determined by clinician follow up following a score of 3 or greater on the CRAFFT) Current suicidal thoughts Eligibility will be determined on a case-by-case basis during the baseline PhQ-9 and MINI Kid assessment process and after a consultation with a licensed mental health clinician has taken place. If adolescent report suicidal ideation on the baseline PhQ-9, and found ineligible, the MINI Kid assessment may not be required. Adolescents with current (within the past 6 months), active suicidal feelings will be excluded. Adolescents with passive thoughts of death or suicide but report to the mental health clinician that they would never act on these thoughts may be admitted, depending on the severity of the risk. Adolescents with past (greater than 6 months ago) ideation who are determined to be low risk will be admitted into the study if there has never been an attempt of moderate or greater lethality. Significant reading impairment (a minimum sixth-grade reading level based on parental report) and/or significant intellectual or developmental disabilities Not willing to comply with the study protocol Did not complete phone assessment with MINI Kid by BCC Not affiliated with any of the sites listed in Appendix A. Parent/guardian does not speak English or Spanish Parent/guardian has a cognitive or intellectual impairment Participant Declined/Changed Mind/Uninterested in participating

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: The Multiphase Optimization Strategy (MOST) will be utilized to optimize a primary care, technology-based intervention (CATCH-IT) for the prevention of depression in at-risk adolescents to optimize efficacy, tolerability and scalability for implementation studies and eventual dissemination. This MOST process includes: (1) theoretical organization of components, target behaviors and links to preventive outcomes (vulnerability and protective factors, likelihood of developing depressive episode), (2) selection of components for factorial design, (3) optimization criteria and (4) factorial design (randomization, intervention delivery, assessments, analysis and optimization). The theoretically grounded components selected are: (1) behavioral activation modules; (2) cognitive-behavioral therapy modules; (3) interpersonal psychotherapy modules; and (4) parent program modules.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1. No adolescent modules + no parent modules<br>No adolescent nor parent modules will be offered to the participant. | |
| Experimental: 2. Adolescent behavioral activation modules only<br>Adolescent behavioral activation modules only | Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training<br>* Self-directed, technology-based, depression prevention program for adolescents and parents.<br>* Other names: CATCH-IT;|
| Experimental: 3. Adolescent cognitive-behavioral therapy modules only<br>Adolescent cognitive-behavioral therapy modules only | Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training<br>* Self-directed, technology-based, depression prevention program for adolescents and parents.<br>* Other names: CATCH-IT;|
| Experimental: 4. Adolescent interpersonal therapy modules only<br>Adolescent interpersonal therapy modules only | Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training<br>* Self-directed, technology-based, depression prevention program for adolescents and parents.<br>* Other names: CATCH-IT;|
| Experimental: 5. Adolescent behavioral activation modules + cognitive-behavioral therapy modules<br>Adolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules | Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training<br>* Self-directed, technology-based, depression prevention program for adolescents and parents.<br>* Other names: CATCH-IT;|
| Experimental: 6. Adolescent behavioral activation modules + interpersonal therapy modules<br>Adolescent behavioral activation modules Adolescent interpersonal therapy modules | Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training<br>* Self-directed, technology-based, depression prevention program for adolescents and parents.<br>* Other names: CATCH-IT;|
| Experimental: 7. Adolescent cognitive-behavioral therapy modules + interpersonal therapy modules<br>Adolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules | Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training<br>* Self-directed, technology-based, depression prevention program for adolescents and parents.<br>* Other names: CATCH-IT;|
| Experimental: 8. Full Adolescent program only<br>Adolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules | Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training<br>* Self-directed, technology-based, depression prevention program for adolescents and parents.<br>* Other names: CATCH-IT;|
| Experimental: 9. Parent program modules only<br>Parent program modules | Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training<br>* Self-directed, technology-based, depression prevention program for adolescents and parents.<br>* Other names: CATCH-IT;|
| Experimental: 10. Adolescent behavioral activation modules + parent program modules<br>Adolescent behavioral activation modules Parent program modules | Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training<br>* Self-directed, technology-based, depression prevention program for adolescents and parents.<br>* Other names: CATCH-IT;|
| Experimental: 11. Adolescent cognitive-behavioral therapy modules + parent program modules<br>Adolescent cognitive-behavioral therapy modules Parent program modules | Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training<br>* Self-directed, technology-based, depression prevention program for adolescents and parents.<br>* Other names: CATCH-IT;|
| Experimental: 12. Adolescent interpersonal therapy modules + parent program modules<br>Adolescent interpersonal therapy modules Parent Program | Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training<br>* Self-directed, technology-based, depression prevention program for adolescents and parents.<br>* Other names: CATCH-IT;|
| Experimental: 13. Adolescent behavioral activation + cognitive-behavioral therapy + parent program modules<br>Adolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules Parent program modules | Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training<br>* Self-directed, technology-based, depression prevention program for adolescents and parents.<br>* Other names: CATCH-IT;|
| Experimental: 14. Adolescent behavioral activation + interpersonal therapy + parent program modules<br>Adolescent behavioral activation modules Adolescent interpersonal therapy modules Parent program modules | Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training<br>* Self-directed, technology-based, depression prevention program for adolescents and parents.<br>* Other names: CATCH-IT;|
| Experimental: 15. Adolescent cognitive-behavioral therapy + interpersonal therapy + parent program modules<br>Adolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules Parent program modules | Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training<br>* Self-directed, technology-based, depression prevention program for adolescents and parents.<br>* Other names: CATCH-IT;|
| Active Comparator: 16. All adolescent + parent program modules<br>Adolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules Parent program modules | Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training<br>* Self-directed, technology-based, depression prevention program for adolescents and parents.<br>* Other names: CATCH-IT;|

What is the study measuring?
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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. 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 12 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 12 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 and 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 12 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 12 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 12 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 12 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 12 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 12 months | 
| Relationships (Life Events) | University of California at Los Angeles (UCLA) Life Events Scale (19-items, self-report) administered to adolescents only. | Baseline through 12 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 12 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). | Start to end of recruitment, 32 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). | Start to end of recruitment, 32 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). | Start to end of recruitment, 32 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 12 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 12 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 12 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 12 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 12 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 12 months | 
| Family Relationships | 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 12 months | 
| Cognitive Style | The Children's Cognitive Style Questionnaire (CCSQ, 6-items, self-report, 5-point Likert scale, 0-150 range, higher score indicates greater negativity of cognitive style). | Baseline through 12 months | 
| Self-efficacy | The Trans-Theoretical Model Scale (TTMS, 10-item, self-report, 4-point Likert scale, 0-24 range, higher score indicates higher self-efficacy and intention to reduce depressive symptoms). | Baseline through 12 months | 
| Social Adjustment | The Social Adjustment Scale-Adolescent version (SAS-SR, 23-item, self-report, 5-point Likert scale, 0-115 range, higher score indicates higher level of social dysfunction). | Baseline through 12 months | 
| Systolic and diastolic blood pressure | Measured in millimeters of mercury. | At baseline | 
| Height | Measure by standard medical office practice measure, without shoes, in centimeters. | At baseline | 
| Weight | Measured in kilograms by standard medical office scale, fully clothed participant. | At baseline | 
| Body Mass Index | Calculated by measuring height (centimeters) and weight (kilogram) to calculate kg/meters squared (BMI, Body Mass Index). | At baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Moderation of COVID-19-related behaviors and consequences | The investigators will examine COVID-19-related behaviors and consequences (e.g. social distancing, sheltering-in-place, family illness and death) that that may be moderators of study outcomes using the Holliston at-Home Questionnaire (a 40-item, adolescent self-report, 5-point Likert scale, 0-150 score range, higher score indicates greater behaviors and consequences). | Baseline through 12 months | 
| Moderation of COVID-19-related social determinants of health | The investigators will examine COVID-19-related social determinants of health (e.g. food insecurity, internet access, unemployment) that may be moderators of study outcomes using the Holliston at-Home Questionnaire (a 40-item, adolescent self-report, 5-point Likert scale, 0-150 score range, higher score indicates greater number of social determinants). | Baseline through 12 months | 

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