The PATHway Study: Primary Care Based Depression Prevention in Adolescents
Purpose
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.
Conditions
- Depression
- Mental Disorder in Adolescence
Eligibility
- Eligible Ages
- Between 13 Years and 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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: 1. 12 or younger 2. 19 or older 2. Adolescent is a non-English speaker/reader 3. On the PHQ-9 screening, depression symptom level is: 1. PHQ-9 = 4 or lower 2. PHQ-9 =19 or higher 4. As assessed by the MINI Kid, a current depressive episode 5. As assessed by the MINI Kid, adolescent meets DSM-5 criteria for a psychotic or bipolar disorder. 6. Currently using medication therapy for depression, anxiety, or other internalizing disorders. 7. Currently engaged in individual treatment for a mood disorder (assessed by BCC during phone screen) 8. Currently engaged in a cognitive-behavioral group or therapy (assessed by BCC during phone screen) 9. Any past psychiatric hospitalizations 10. Any past suicide attempt or incident of self-harm with moderate or greater lethality 11. Extreme, current drug/alcohol abuse (determined by clinician follow up following a score of 3 or greater on the CRAFFT) 12. Current suicidal thoughts 1. 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. 2. Adolescents with current (within the past 6 months), active suicidal feelings will be excluded. 3. 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. 4. 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. 13. Significant reading impairment (a minimum sixth-grade reading level based on parental report) and/or significant intellectual or developmental disabilities 14. Not willing to comply with the study protocol 15. Did not complete phone assessment with MINI Kid by BCC 16. Not affiliated with any of the sites listed in Appendix A. 17. Parent/guardian does not speak English or Spanish 18. Parent/guardian has a cognitive or intellectual impairment 19. Participant Declined/Changed Mind/Uninterested in participating
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial Assignment
- Intervention 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.
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
- Masking Description
- Subjects will know the condition to which they are randomized when opening their CATCH-IT login, as the number of components will be apparent on the sidebar of the webpage. All clinical evaluators conducting the MINI Kid and other psychological assessments will work out of the Boston Call Center and they will be the only staff blinded to group assignment.
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
No Intervention 1. No adolescent modules + no parent modules |
No adolescent nor parent modules will be offered to the participant. |
|
Experimental 2. Adolescent behavioral activation modules only |
Adolescent behavioral activation modules only |
|
Experimental 3. Adolescent cognitive-behavioral therapy modules only |
Adolescent cognitive-behavioral therapy modules only |
|
Experimental 4. Adolescent interpersonal therapy modules only |
Adolescent interpersonal therapy modules only |
|
Experimental 5. Adolescent behavioral activation modules + cognitive-behavioral therapy modules |
Adolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules |
|
Experimental 6. Adolescent behavioral activation modules + interpersonal therapy modules |
Adolescent behavioral activation modules Adolescent interpersonal therapy modules |
|
Experimental 7. Adolescent cognitive-behavioral therapy modules + interpersonal therapy modules |
Adolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules |
|
Experimental 8. Full Adolescent program only |
Adolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules |
|
Experimental 9. Parent program modules only |
Parent program modules |
|
Experimental 10. Adolescent behavioral activation modules + parent program modules |
Adolescent behavioral activation modules Parent program modules |
|
Experimental 11. Adolescent cognitive-behavioral therapy modules + parent program modules |
Adolescent cognitive-behavioral therapy modules Parent program modules |
|
Experimental 12. Adolescent interpersonal therapy modules + parent program modules |
Adolescent interpersonal therapy modules Parent Program |
|
Experimental 13. Adolescent behavioral activation + cognitive-behavioral therapy + parent program modules |
Adolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules Parent program modules |
|
Experimental 14. Adolescent behavioral activation + interpersonal therapy + parent program modules |
Adolescent behavioral activation modules Adolescent interpersonal therapy modules Parent program modules |
|
Experimental 15. Adolescent cognitive-behavioral therapy + interpersonal therapy + parent program modules |
Adolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules Parent program modules |
|
Active Comparator 16. All adolescent + parent program modules |
Adolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules Parent program modules |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- University of Illinois at Chicago
Detailed Description
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.