The PATHway Study: Primary Care Based Depression Prevention in Adolescents

Not Applicable

Active, not recruiting

• Conditions: Mental Disorder in Adolescence; Depression
• Interventions: Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training

• Registration Number: NCT05203198
• Lead Sponsor: University of Illinois at Chicago

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.

Study Timeline

• Study First Submitted: 2022-01-10
• Study First Submitted QC: 2022-01-10
• Study First Posted: 2022-01-24
• Study Start: 2022-02-01
• Status Verified: 2024-12
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-07
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
5. Adolescent behavioral activation modules + cognitive-behavioral therapy modules	Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training	Adolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules
6. Adolescent behavioral activation modules + interpersonal therapy modules	Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training	Adolescent behavioral activation modules Adolescent interpersonal therapy modules
7. Adolescent cognitive-behavioral therapy modules + interpersonal therapy modules	Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training	Adolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules
12. Adolescent interpersonal therapy modules + parent program modules	Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training	Adolescent interpersonal therapy modules Parent Program
13. Adolescent behavioral activation + cognitive-behavioral therapy + parent program modules	Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training	Adolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules Parent program modules
2. Adolescent behavioral activation modules only	Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training	Adolescent behavioral activation modules only
4. Adolescent interpersonal therapy modules only	Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training	Adolescent interpersonal therapy modules only
10. Adolescent behavioral activation modules + parent program modules	Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training	Adolescent behavioral activation modules Parent program modules
15. Adolescent cognitive-behavioral therapy + interpersonal therapy + parent program modules	Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training	Adolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules Parent program modules
3. Adolescent cognitive-behavioral therapy modules only	Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training	Adolescent cognitive-behavioral therapy modules only
9. Parent program modules only	Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training	Parent program modules
11. Adolescent cognitive-behavioral therapy modules + parent program modules	Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training	Adolescent cognitive-behavioral therapy modules Parent program modules
14. Adolescent behavioral activation + interpersonal therapy + parent program modules	Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training	Adolescent behavioral activation modules Adolescent interpersonal therapy modules Parent program modules
8. Full Adolescent program only	Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training	Adolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules
16. All adolescent + parent program modules	Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training	Adolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules Parent program modules

Primary Outcome Measures

Name	Time	Method
Function	Baseline through 12 months	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.
Feasibility of Intervention	Start to end of recruitment, 32 months	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).
Substance Abuse Symptoms	Baseline through 12 months	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).
Systolic and diastolic blood pressure	At baseline	Measured in millimeters of mercury.
Height	At baseline	Measure by standard medical office practice measure, without shoes, in centimeters.
Relationships (Life Events)	Baseline through 12 months	University of California at Los Angeles (UCLA) Life Events Scale (19-items, self-report) administered to adolescents only.
Time	Baseline through 12 months	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.
Cost	Baseline through 12 months	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).
Depressive and mental disorder episodes	Baseline through 12 months	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.
Cultural acceptability adolescent and family	Baseline through 12 months	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."
Stress symptoms	Baseline through 12 months	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).
Externalizing Behavior Symptoms	Baseline through 12 months	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).
Depressive Symptoms	Baseline through 12 months	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).
Intervention Appropriateness	Start to end of recruitment, 32 months	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).
Anxiety Symptoms	Baseline through 12 months	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).
Cognitive Style	Baseline through 12 months	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).
Resiliency	Baseline through 12 months	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).
Post Traumatic Stress Disorder Symptoms	Baseline through 12 months	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).
Dysfunctional Attitudes	Baseline through 12 months	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).
Self-efficacy	Baseline through 12 months	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).
Weight	At baseline	Measured in kilograms by standard medical office scale, fully clothed participant.
Body Mass Index	At baseline	Calculated by measuring height (centimeters) and weight (kilogram) to calculate kg/meters squared (BMI, Body Mass Index).
Socio-cultural Relevance	Baseline through 12 months	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)
Acceptability of Intervention	Start to end of recruitment, 32 months	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).
Rumination	Baseline through 12 months	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).
Social Adjustment	Baseline through 12 months	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).
Family Relationships	Baseline through 12 months	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).

Secondary Outcome Measures

Name	Time	Method
Moderation of COVID-19-related social determinants of health	Baseline through 12 months	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).
Moderation of COVID-19-related behaviors and consequences	Baseline through 12 months	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).

Trial Locations

Locations (6)

Ann & Robert H. Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States

UI Health; 🇺🇸 Chicago, Illinois, United States

University of Chicago Comer Children's Hospital; 🇺🇸 Chicago, Illinois, United States

Northshore University HealthSystem; 🇺🇸 Glenview, Illinois, United States

Advocate Aurora Health; 🇺🇸 Park Ridge, Illinois, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States