Clinical trial NCT05203198: The PATHway Study: Primary Care Based Depression Prevention in Adolescents
Official title: Primary Care Based Depression Prevention in Adolescents: Intervention Optimization in Preparation for Implementation Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Mental Disorder in Adolescence
Keywords: Adolescents Depression
Internet intervention
Cognitive-Behavioral Therapy
Prevention
MOST design
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Wake Forest University Health Sciences
name: Endeavor Health
name: University of Chicago
name: National Institute of Mental Health (NIMH)
name: Mile Square Health Center
name: Lawndale Christian Health Center
name: Ann & Robert H Lurie Children's Hospital of Chicago
First posted: 2022-01-24
Enrollment: 400
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time
timeFrame: Baseline through 12 months
measure: Cultural acceptability adolescent and family
timeFrame: Baseline through 12 months
measure: Cost
timeFrame: Baseline through 12 months
measure: Depressive Symptoms
timeFrame: Baseline through 12 months
measure: Depressive and mental disorder episodes
timeFrame: Baseline through 12 months
measure: Stress symptoms
timeFrame: Baseline through 12 months
measure: Resiliency
timeFrame: Baseline through 12 months
measure: Function
timeFrame: Baseline through 12 months
measure: Relationships (Life Events)
timeFrame: Baseline through 12 months
measure: Socio-cultural Relevance
timeFrame: Baseline through 12 months
measure: Acceptability of Intervention
timeFrame: Start to end of recruitment, 32 months
measure: Feasibility of Intervention
timeFrame: Start to end of recruitment, 32 months
measure: Intervention Appropriateness
timeFrame: Start to end of recruitment, 32 months
measure: Externalizing Behavior Symptoms
timeFrame: Baseline through 12 months
measure: Anxiety Symptoms
timeFrame: Baseline through 12 months
measure: Substance Abuse Symptoms
timeFrame: Baseline through 12 months
measure: Post Traumatic Stress Disorder Symptoms
timeFrame: Baseline through 12 months
measure: Rumination
timeFrame: Baseline through 12 months
measure: Dysfunctional Attitudes
timeFrame: Baseline through 12 months
measure: Family Relationships
timeFrame: Baseline through 12 months
measure: Cognitive Style
timeFrame: Baseline through 12 months
measure: Self-efficacy
timeFrame: Baseline through 12 months
measure: Social Adjustment
timeFrame: Baseline through 12 months
measure: Systolic and diastolic blood pressure
timeFrame: At baseline
measure: Height
timeFrame: At baseline
measure: Weight
timeFrame: At baseline
measure: Body Mass Index
timeFrame: At baseline
Secondary outcomes:
measure: Moderation of COVID-19-related behaviors and consequences
timeFrame: Baseline through 12 months
measure: Moderation of COVID-19-related social determinants of health
timeFrame: Baseline through 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: UI Health
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Comer Children's Hospital
state: Illinois
city: Glenview
country: United States
facility: Northshore University HealthSystem
state: Illinois
city: Park Ridge
country: United States
facility: Advocate Aurora Health
state: Illinois
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UIC, College of Medicine
name: Benjamin W Van Voorhees, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Wellesley College
name: Tracy RG Gladstone, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UIC, College of Medicine
name: Calvin Rusiewski, MBBS
role: STUDY_DIRECTOR
References: