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

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

  1. 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

ArmDescriptionAssigned 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
  • Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training
    Self-directed, technology-based, depression prevention program for adolescents and parents.
    Other names:
    • CATCH-IT
Experimental
3. Adolescent cognitive-behavioral therapy modules only
Adolescent cognitive-behavioral therapy modules only
  • Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training
    Self-directed, technology-based, depression prevention program for adolescents and parents.
    Other names:
    • CATCH-IT
Experimental
4. Adolescent interpersonal therapy modules only
Adolescent interpersonal therapy modules only
  • Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training
    Self-directed, technology-based, depression prevention program for adolescents and parents.
    Other names:
    • CATCH-IT
Experimental
5. Adolescent behavioral activation modules + cognitive-behavioral therapy modules
Adolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules
  • Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training
    Self-directed, technology-based, depression prevention program for adolescents and parents.
    Other names:
    • CATCH-IT
Experimental
6. Adolescent behavioral activation modules + interpersonal therapy modules
Adolescent behavioral activation modules Adolescent interpersonal therapy modules
  • Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training
    Self-directed, technology-based, depression prevention program for adolescents and parents.
    Other names:
    • CATCH-IT
Experimental
7. Adolescent cognitive-behavioral therapy modules + interpersonal therapy modules
Adolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules
  • Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training
    Self-directed, technology-based, depression prevention program for adolescents and parents.
    Other names:
    • CATCH-IT
Experimental
8. Full Adolescent program only
Adolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules
  • Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training
    Self-directed, technology-based, depression prevention program for adolescents and parents.
    Other names:
    • CATCH-IT
Experimental
9. Parent program modules only
Parent program modules
  • Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training
    Self-directed, technology-based, depression prevention program for adolescents and parents.
    Other names:
    • CATCH-IT
Experimental
10. Adolescent behavioral activation modules + parent program modules
Adolescent behavioral activation modules Parent program modules
  • Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training
    Self-directed, technology-based, depression prevention program for adolescents and parents.
    Other names:
    • CATCH-IT
Experimental
11. Adolescent cognitive-behavioral therapy modules + parent program modules
Adolescent cognitive-behavioral therapy modules Parent program modules
  • Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training
    Self-directed, technology-based, depression prevention program for adolescents and parents.
    Other names:
    • CATCH-IT
Experimental
12. Adolescent interpersonal therapy modules + parent program modules
Adolescent interpersonal therapy modules Parent Program
  • Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training
    Self-directed, technology-based, depression prevention program for adolescents and parents.
    Other names:
    • CATCH-IT
Experimental
13. Adolescent behavioral activation + cognitive-behavioral therapy + parent program modules
Adolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules Parent program modules
  • Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training
    Self-directed, technology-based, depression prevention program for adolescents and parents.
    Other names:
    • CATCH-IT
Experimental
14. Adolescent behavioral activation + interpersonal therapy + parent program modules
Adolescent behavioral activation modules Adolescent interpersonal therapy modules Parent program modules
  • Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training
    Self-directed, technology-based, depression prevention program for adolescents and parents.
    Other names:
    • CATCH-IT
Experimental
15. Adolescent cognitive-behavioral therapy + interpersonal therapy + parent program modules
Adolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules Parent program modules
  • Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training
    Self-directed, technology-based, depression prevention program for adolescents and parents.
    Other names:
    • CATCH-IT
Active Comparator
16. All adolescent + parent program modules
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
    Self-directed, technology-based, depression prevention program for adolescents and parents.
    Other names:
    • CATCH-IT

Recruiting Locations

More Details

Status
Recruiting
Sponsor
University of Illinois at Chicago

Study Contact

Benjamin W Van Voorhees, MD, MPH
312-996-8352
bvanvoor@uic.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.