DepressionPATHwayNCT05203198
The PATHway Study: Primary Care Based Depression Prevention in Adolescents
A study testing Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training in people with Depression and Mental Disorder in Adolescence, run by University of Illinois Chicago at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Mental Disorder in Adolescence
- What is being tested?
- Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Feb 2022to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Outside age range:
- 12 or younger
- 19 or older
- Adolescent is a non-English speaker/reader
- On the PHQ-9 screening, depression symptom level is:
- PHQ-9 = 4 or lower
Show all 27Show fewer
- PHQ-9 =19 or higher
- As assessed by the MINI Kid, a current depressive episode
- As assessed by the MINI Kid, adolescent meets DSM-5 criteria for a psychotic or bipolar disorder.
- Currently using medication therapy for depression, anxiety, or other internalizing disorders.
- Currently engaged in individual treatment for a mood disorder (assessed by BCC during phone screen)
- Currently engaged in a cognitive-behavioral group or therapy (assessed by BCC during phone screen)
- Any past psychiatric hospitalizations
- Any past suicide attempt or incident of self-harm with moderate or greater lethality
- Extreme, current drug/alcohol abuse (determined by clinician follow up following a score of 3 or greater on the CRAFFT)
- 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.
- Significant reading impairment (a minimum sixth-grade reading level based on parental report) and/or significant intellectual or developmental disabilities
- Not willing to comply with the study protocol
- Did not complete phone assessment with MINI Kid by BCC
- Not affiliated with any of the sites listed in Appendix A.
- Parent/guardian does not speak English or Spanish
- Parent/guardian has a cognitive or intellectual impairment
- Participant Declined/Changed Mind/Uninterested in participating
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
UI Health
Chicago, Illinois, 60612
University of Chicago Comer Children's Hospital
Chicago, Illinois, 60637
UT Southwestern Medical Center
Dallas, Texas, 75390
Northshore University HealthSystem
Glenview, Illinois, 60026
Advocate Aurora Health
Park Ridge, Illinois, 60068
About this study
Official title: Primary Care Based Depression Prevention in Adolescents: Intervention Optimization in Preparation for Implementation Study
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.
Read the 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.
- Conditions
- Depression, Mental Disorder in Adolescence
- Being tested
- Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training
- Keywords
- Adolescents Depression, Internet intervention, Cognitive-Behavioral Therapy, Prevention, MOST design
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal TrainingBehavioural
Also called CATCH-IT
Self-directed, technology-based, depression prevention program for adolescents and parents.
| Study group | Role | What they receive |
|---|---|---|
| 1. No adolescent modules + no parent modules | No intervention | No adolescent nor parent modules will be offered to the participant. |
| 2. Adolescent behavioral activation modules only | Experimental | Adolescent behavioral activation modules only Receives: Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training |
| 3. Adolescent cognitive-behavioral therapy modules only | Experimental | Adolescent cognitive-behavioral therapy modules only Receives: Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training |
| 4. Adolescent interpersonal therapy modules only | Experimental | Adolescent interpersonal therapy modules only Receives: Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training |
| 5. Adolescent behavioral activation modules + cognitive-behavioral therapy modules | Experimental | Adolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules Receives: Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training |
| 6. Adolescent behavioral activation modules + interpersonal therapy modules | Experimental | Adolescent behavioral activation modules Adolescent interpersonal therapy modules Receives: Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training |
| 7. Adolescent cognitive-behavioral therapy modules + interpersonal therapy modules | Experimental | Adolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules Receives: Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training |
| 8. Full Adolescent program only | Experimental | Adolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules Receives: Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training |
| 9. Parent program modules only | Experimental | Parent program modules Receives: Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training |
| 10. Adolescent behavioral activation modules + parent program modules | Experimental | Adolescent behavioral activation modules Parent program modules Receives: Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training |
| 11. Adolescent cognitive-behavioral therapy modules + parent program modules | Experimental | Adolescent cognitive-behavioral therapy modules Parent program modules Receives: Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training |
| 12. Adolescent interpersonal therapy modules + parent program modules | Experimental | Adolescent interpersonal therapy modules Parent Program Receives: Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training |
| 13. Adolescent behavioral activation + cognitive-behavioral therapy + parent program modules | Experimental | Adolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules Parent program modules Receives: Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training |
| 14. Adolescent behavioral activation + interpersonal therapy + parent program modules | Experimental | Adolescent behavioral activation modules Adolescent interpersonal therapy modules Parent program modules Receives: Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training |
| 15. Adolescent cognitive-behavioral therapy + interpersonal therapy + parent program modules | Experimental | Adolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules Parent program modules Receives: Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training |
| 16. All adolescent + parent program modules | Active comparator | Adolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules Parent program modules Receives: Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time
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.
Measured: Baseline through 12 months
Cultural acceptability adolescent and family
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."
Measured: Baseline through 12 months
Cost
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).
Measured: Baseline through 12 months
Depressive Symptoms
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).
Measured: Baseline through 12 months
Depressive and mental disorder episodes
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.
Measured: Baseline through 12 months
Stress symptoms
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).
Measured: Baseline through 12 months
Resiliency
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).
Measured: Baseline through 12 months
Function
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.
Measured: Baseline through 12 months
Relationships (Life Events)
University of California at Los Angeles (UCLA) Life Events Scale (19-items, self-report) administered to adolescents only.
Measured: Baseline through 12 months
Socio-cultural Relevance
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)
Measured: Baseline through 12 months
Acceptability of Intervention
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).
Measured: Start to end of recruitment, 32 months
Feasibility of Intervention
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).
Measured: Start to end of recruitment, 32 months
Intervention Appropriateness
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).
Measured: Start to end of recruitment, 32 months
Externalizing Behavior Symptoms
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).
Measured: Baseline through 12 months
Anxiety Symptoms
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).
Measured: Baseline through 12 months
Substance Abuse Symptoms
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).
Measured: Baseline through 12 months
Post Traumatic Stress Disorder Symptoms
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).
Measured: Baseline through 12 months
Rumination
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).
Measured: Baseline through 12 months
Dysfunctional Attitudes
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).
Measured: Baseline through 12 months
Family Relationships
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).
Measured: Baseline through 12 months
Cognitive Style
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).
Measured: Baseline through 12 months
Self-efficacy
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).
Measured: Baseline through 12 months
Social Adjustment
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).
Measured: Baseline through 12 months
Systolic and diastolic blood pressure
Measured in millimeters of mercury.
Measured: At baseline
Height
Measure by standard medical office practice measure, without shoes, in centimeters.
Measured: At baseline
Weight
Measured in kilograms by standard medical office scale, fully clothed participant.
Measured: At baseline
Body Mass Index
Calculated by measuring height (centimeters) and weight (kilogram) to calculate kg/meters squared (BMI, Body Mass Index).
Measured: At baseline
Secondary outcomes (2)
Moderation of COVID-19-related behaviors and consequences
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).
Measured: Baseline through 12 months
Moderation of COVID-19-related social determinants of health
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).
Measured: Baseline through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start1 Feb 2022
- Primary completion31 Mar 2026
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University Health Sciences, Endeavor Health, University of Chicago, National Institute of Mental Health (NIMH), Mile Square Health Center, Lawndale Christian Health Center, Ann & Robert H Lurie Children's Hospital of Chicago
- Responsible party
- Principal investigator, Benjamin Van Voorhees, MD, MPH, University of Illinois Chicago
- Investigators
- Benjamin W Van Voorhees, MD, MPH, Principal investigator, UIC, College of MedicineTracy RG Gladstone, PhD, Principal investigator, Wellesley CollegeCalvin Rusiewski, MBBS, Study director, UIC, College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203198
- Sponsor's protocol ID
- CHAIRb 20080601
- Other IDs
- 1R01MH124723-01, 3R01MH124723-04S1
- Acronym
- PATHway
- Status last verified
- Jun 2026
- First submitted
- 10 Jan 2022
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Based Depression Prevention in Adolescents: Intervention Optimization in Preparation for Implementation Study
- ClinicalTrials.gov ID
- NCT05203198
- Acronym / sponsor ID
- PATHway / CHAIRb 20080601
- Conditions
- Depression, Mental Disorder in Adolescence
- Keywords
- Adolescents Depression, Internet intervention, Cognitive-Behavioral Therapy, Prevention, MOST design
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Wake Forest University Health Sciences, Endeavor Health, University of Chicago, National Institute of Mental Health (NIMH), Mile Square Health Center, Lawndale Christian Health Center, Ann & Robert H Lurie Children's Hospital of Chicago
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 16
- 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.
| Arm | Type | Receives |
|---|---|---|
| 1. No adolescent modules + no parent modules | No intervention | –No adolescent nor parent modules will be offered to the participant. |
| 2. Adolescent behavioral activation modules only | Experimental | Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal TrainingAdolescent behavioral activation modules only |
| 3. Adolescent cognitive-behavioral therapy modules only | Experimental | Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal TrainingAdolescent cognitive-behavioral therapy modules only |
| 4. Adolescent interpersonal therapy modules only | Experimental | Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal TrainingAdolescent interpersonal therapy modules only |
| 5. Adolescent behavioral activation modules + cognitive-behavioral therapy modules | Experimental | Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal TrainingAdolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules |
| 6. Adolescent behavioral activation modules + interpersonal therapy modules | Experimental | Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal TrainingAdolescent behavioral activation modules Adolescent interpersonal therapy modules |
| 7. Adolescent cognitive-behavioral therapy modules + interpersonal therapy modules | Experimental | Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal TrainingAdolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules |
| 8. Full Adolescent program only | Experimental | Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal TrainingAdolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules |
| 9. Parent program modules only | Experimental | Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal TrainingParent program modules |
| 10. Adolescent behavioral activation modules + parent program modules | Experimental | Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal TrainingAdolescent behavioral activation modules Parent program modules |
| 11. Adolescent cognitive-behavioral therapy modules + parent program modules | Experimental | Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal TrainingAdolescent cognitive-behavioral therapy modules Parent program modules |
| 12. Adolescent interpersonal therapy modules + parent program modules | Experimental | Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal TrainingAdolescent interpersonal therapy modules Parent Program |
| 13. Adolescent behavioral activation + cognitive-behavioral therapy + parent program modules | Experimental | Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal TrainingAdolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules Parent program modules |
| 14. Adolescent behavioral activation + interpersonal therapy + parent program modules | Experimental | Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal TrainingAdolescent behavioral activation modules Adolescent interpersonal therapy modules Parent program modules |
| 15. Adolescent cognitive-behavioral therapy + interpersonal therapy + parent program modules | Experimental | Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal TrainingAdolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules Parent program modules |
| 16. All adolescent + parent program modules | Active comparator | Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal TrainingAdolescent behavioral activation modules Adolescent cognitive-behavioral therapy modules Adolescent interpersonal therapy modules Parent program modules |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (27 listed)
- Outside age range:
- Adolescent is a non-English speaker/reader
- On the PHQ-9 screening, depression symptom level is:
- As assessed by the MINI Kid, a current depressive episode
- As assessed by the MINI Kid, adolescent meets DSM-5 criteria for a psychotic or bipolar disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal TrainingAlso: CATCH-ITSelf-directed, technology-based, depression prevention program for adolescents and parents. | Behavioural | 10. Adolescent behavioral activation modules + parent program modules, 11. Adolescent cognitive-behavioral therapy modules + parent program modules, 12. Adolescent interpersonal therapy modules + parent program modules, 13. Adolescent behavioral activation + cognitive-behavioral therapy + parent program modules, 14. Adolescent behavioral activation + interpersonal therapy + parent program modules, 15. Adolescent cognitive-behavioral therapy + interpersonal therapy + parent program modules, 16. All adolescent + parent program modules, 2. Adolescent behavioral activation modules only, 3. Adolescent cognitive-behavioral therapy modules only, 4. Adolescent interpersonal therapy modules only, 5. Adolescent behavioral activation modules + cognitive-behavioral therapy modules, 6. Adolescent behavioral activation modules + interpersonal therapy modules, 7. Adolescent cognitive-behavioral therapy modules + interpersonal therapy modules, 8. Full Adolescent program only, 9. Parent program modules only |
Primary outcome
Time
Time frame: 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.
Cultural acceptability adolescent and family
Time frame: 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."
Cost
Time frame: 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 Symptoms
Time frame: 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).
Depressive and mental disorder episodes
Time frame: 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.
Stress symptoms
Time frame: 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).
Resiliency
Time frame: 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).
Function
Time frame: 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.
Relationships (Life Events)
Time frame: Baseline through 12 months
University of California at Los Angeles (UCLA) Life Events Scale (19-items, self-report) administered to adolescents only.
Socio-cultural Relevance
Time frame: 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
Time frame: 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).
Feasibility of Intervention
Time frame: 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).
Intervention Appropriateness
Time frame: 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).
Externalizing Behavior Symptoms
Time frame: 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).
Anxiety Symptoms
Time frame: 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).
Substance Abuse Symptoms
Time frame: 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).
Post Traumatic Stress Disorder Symptoms
Time frame: 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).
Rumination
Time frame: 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).
Dysfunctional Attitudes
Time frame: 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).
Family Relationships
Time frame: 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).
Cognitive Style
Time frame: 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).
Self-efficacy
Time frame: 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).
Social Adjustment
Time frame: 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).
Systolic and diastolic blood pressure
Time frame: At baseline
Measured in millimeters of mercury.
Height
Time frame: At baseline
Measure by standard medical office practice measure, without shoes, in centimeters.
Weight
Time frame: At baseline
Measured in kilograms by standard medical office scale, fully clothed participant.
Body Mass Index
Time frame: At baseline
Calculated by measuring height (centimeters) and weight (kilogram) to calculate kg/meters squared (BMI, Body Mass Index).
2 secondary outcomes
Moderation of COVID-19-related behaviors and consequences
Time frame: Baseline through 12 months
Moderation of COVID-19-related social determinants of health
Time frame: Baseline through 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin W Van Voorhees, MD, MPH principal investigator
UIC, College of Medicine
Tracy RG Gladstone, PhD principal investigator
Wellesley College
Calvin Rusiewski, MBBS study director
UIC, College of Medicine
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training in people with Depression and Mental Disorder in Adolescence, run by University of Illinois Chicago at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time (time frame: Baseline through 12 months). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.