The PATHway Study: Primary Care Based Depression Prevention in Adolescents
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Treatments
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Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
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Outside age range:
- 12 or younger
- 19 or older
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Adolescent is a non-English speaker/reader
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On the PHQ-9 screening, depression symptom level is:
- PHQ-9 = 4 or lower
- PHQ-9 =19 or higher
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As assessed by the MINI Kid, a current depressive episode
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As assessed by the MINI Kid, adolescent meets DSM-5 criteria for a psychotic or bipolar disorder.
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Currently using medication therapy for depression, anxiety, or other internalizing disorders.
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Currently engaged in individual treatment for a mood disorder (assessed by BCC during phone screen)
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Currently engaged in a cognitive-behavioral group or therapy (assessed by BCC during phone screen)
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Any past psychiatric hospitalizations
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Any past suicide attempt or incident of self-harm with moderate or greater lethality
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Extreme, current drug/alcohol abuse (determined by clinician follow up following a score of 3 or greater on the CRAFFT)
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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.
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Significant reading impairment (a minimum sixth-grade reading level based on parental report) and/or significant intellectual or developmental disabilities
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Not willing to comply with the study protocol
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Did not complete phone assessment with MINI Kid by BCC
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Not affiliated with any of the sites listed in Appendix A.
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Parent/guardian does not speak English or Spanish
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Parent/guardian has a cognitive or intellectual impairment
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Participant Declined/Changed Mind/Uninterested in participating
Trial design
Primary purpose
Allocation
Interventional model
Masking
400 participants in 16 patient groups
Trial contacts and locations
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Central trial contact
Benjamin W Van Voorhees, MD, MPH; Rebecca T Feinstein, PhD
Data sourced from clinicaltrials.gov
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