The PATHway Study: Primary Care Based Depression Prevention in Adolescents (PATHway)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05203198 |
Recruitment Status :
Recruiting
First Posted : January 24, 2022
Last Update Posted : May 26, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Depression Mental Disorder in Adolescence | Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 400 participants |
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. |
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. |
Primary Purpose: | Prevention |
Official Title: | Primary Care Based Depression Prevention in Adolescents: Intervention Optimization in Preparation for Implementation Study |
Actual Study Start Date : | December 1, 2021 |
Estimated Primary Completion Date : | August 1, 2024 |
Estimated Study Completion Date : | August 31, 2024 |

Arm | Intervention/treatment |
---|---|
No Intervention: 1. No adolescent modules + no parent modules
No adolescent nor parent modules will be offered to the participant.
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Experimental: 2. Adolescent behavioral activation modules only
Adolescent behavioral activation modules only
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Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training
Self-directed, technology-based, depression prevention program for adolescents and parents.
Other Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: CATCH-IT |
- 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).
- Moderation of COVID-19-related behaviors and consequences [ Time Frame: 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).
- Moderation of COVID-19-related social determinants of health [ Time Frame: 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).

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 13 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | 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:
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Outside age range:
- 12 or younger
- 19 or older
- Adolescent is a non-English speaker/reader
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On the PHQ-9 screening, depression symptom level is:
- PHQ-9 = 4 or lower
- PHQ-9 =19 or higher
- 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)
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Current suicidal thoughts
- Eligibility will be determined on a case-by-case basis during the baseline PhQ-9 and MINI Kid assessment process and after a consultation with a licensed mental health clinician has taken place. If adolescent report suicidal ideation on the baseline PhQ-9, and found ineligible, the MINI Kid assessment may not be required.
- Adolescents with current (within the past 6 months), active suicidal feelings will be excluded.
- Adolescents with passive thoughts of death or suicide but report to the mental health clinician that they would never act on these thoughts may be admitted, depending on the severity of the risk.
- Adolescents with past (greater than 6 months ago) ideation who are determined to be low risk will be admitted into the study if there has never been an attempt of moderate or greater lethality.
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05203198
Contact: Benjamin W Van Voorhees, MD, MPH | 312-996-8352 | bvanvoor@uic.edu | |
Contact: Rebecca T Feinstein, PhD | 3129962024 | rfeinst@uic.edu |
United States, Illinois | |
Ann & Robert H. Lurie Children's Hospital of Chicago | Recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: Lisa Simmons, MD 312-227-6800 LSimons@luriechildrens.org | |
Contact: Gregg Montalto, MD 312-227-6800 gmontalto@luriechildrens.org | |
Principal Investigator: Lisa Simmons, MD | |
Principal Investigator: Gregg Montalto, MD | |
UI Health | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Benjamin W Van Voorhees, MD, MPH 312-996-8297 bvanvoor@uic.edu | |
Contact: Rebecca T Feinstein, PhD 312-996-2024 rfeinst@uic.edu | |
Principal Investigator: Benjamin W Van Voorhees, MD, MPH | |
Sub-Investigator: Rebecca T Feinstein, PhD | |
Sub-Investigator: Marian L Fitzgibbon, PhD | |
Sub-Investigator: Michael L Berbaum, PhD | |
Sub-Investigator: Kathleen Diviak, PhD | |
Sub-Investigator: Tianxiu Wang, PhD | |
Sub-Investigator: Jennifer Sanchez-Flack, PhD | |
Sub-Investigator: Kristen Kenan, MD, MPH | |
Sub-Investigator: Jennifer Duffecy, PhD | |
University of Chicago Comer Children's Hospital | Not yet recruiting |
Chicago, Illinois, United States, 60637 | |
Contact: James Mitchell, MD 773-702-1903 jmitchell@peds.bsd.uchicago.edu | |
Principal Investigator: James Mitchell, MD | |
Northshore University HealthSystem | Recruiting |
Glenview, Illinois, United States, 60026 | |
Contact: Jason Canel, MD 847-832-6500 jcanel@NorthShore.org | |
Principal Investigator: Jason Canel, MD | |
Advocate Aurora Health | Recruiting |
Park Ridge, Illinois, United States, 60068 | |
Contact: Cheryl Lefavier, PhD, RN 708-684-4210 cheryl.lefaiver@aah.org | |
Contact: Ashley McHugh 847-723-9373 Ashley.Mchugh@aah.org | |
Principal Investigator: Cheryl Lefavier, PhD, RN | |
Principal Investigator: Cathy Joyce, MD, PhD | |
United States, Texas | |
UT Southwestern Medical Center | Recruiting |
Dallas, Texas, United States, 75390 | |
Contact: Olga Gupta, MD 214-456-5959 Olga.Gupta@UTSouthwestern.edu | |
Principal Investigator: Olga Gupta, MD |
Principal Investigator: | Benjamin W Van Voorhees, MD, MPH | UIC, College of Medicine | |
Principal Investigator: | Tracy RG Gladstone, PhD | Wellesley College | |
Study Director: | Matthew Lowther, MSW, MPH | UIC, College of Medicine |
Responsible Party: | Benjamin Van Voorhees, MD, MPH, Professor and Head, Department of Pediatrics, University of Illinois at Chicago |
ClinicalTrials.gov Identifier: | NCT05203198 |
Other Study ID Numbers: |
CHAIRb 20080601 1R01MH124723-01 ( U.S. NIH Grant/Contract ) |
First Posted: | January 24, 2022 Key Record Dates |
Last Update Posted: | May 26, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Adolescents Depression Internet intervention Cognitive-Behavioral Therapy Prevention MOST design |
Depression Depressive Disorder Mental Disorders Behavioral Symptoms Mood Disorders |