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The PATHway Study: Primary Care Based Depression Prevention in Adolescents (PATHway)

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
Sponsor:
Collaborators:
Wellesley College
Advocate Health Care
NorthShore University HealthSystem
Ann & Robert H Lurie Children's Hospital of Chicago
University of Chicago
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Benjamin Van Voorhees, MD, MPH, 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.

Condition or disease Intervention/treatment Phase
Depression Mental Disorder in Adolescence Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training Not Applicable

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.

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: 1. No adolescent modules + no parent modules
No adolescent nor parent modules will be offered to the participant.
Experimental: 2. Adolescent behavioral activation modules only
Adolescent behavioral activation modules only
Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training
Self-directed, technology-based, depression prevention program for adolescents and parents.
Other 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




Primary Outcome Measures :
  1. 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.

  2. 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."

  3. 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).

  4. 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).

  5. 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.

  6. 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).

  7. 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).

  8. 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.

  9. 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.

  10. 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)

  11. 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).

  12. 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).

  13. 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).

  14. 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).

  15. 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).

  16. 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).

  17. 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).

  18. 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).

  19. 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).

  20. 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).

  21. 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).

  22. 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).

  23. 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).

  24. Systolic and diastolic blood pressure [ Time Frame: At baseline ]
    Measured in millimeters of mercury.

  25. Height [ Time Frame: At baseline ]
    Measure by standard medical office practice measure, without shoes, in centimeters.

  26. Weight [ Time Frame: At baseline ]
    Measured in kilograms by standard medical office scale, fully clothed participant.

  27. Body Mass Index [ Time Frame: At baseline ]
    Calculated by measuring height (centimeters) and weight (kilogram) to calculate kg/meters squared (BMI, Body Mass Index).


Secondary Outcome Measures :
  1. 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).

  2. 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).



Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adolescents ages 13 through 18 years, and
  • Adolescents must be experiencing an elevated level of depressive symptoms (PHQ-9 = 5-18), and
  • Adolescents will be included if they have had past depressive episode/s, but not if they are in a current depressive episode.

Exclusion Criteria:

  1. Outside age range:

    1. 12 or younger
    2. 19 or older
  2. Adolescent is a non-English speaker/reader
  3. On the PHQ-9 screening, depression symptom level is:

    1. PHQ-9 = 4 or lower
    2. PHQ-9 =19 or higher
  4. As assessed by the MINI Kid, a current depressive episode
  5. As assessed by the MINI Kid, adolescent meets DSM-5 criteria for a psychotic or bipolar disorder.
  6. Currently using medication therapy for depression, anxiety, or other internalizing disorders.
  7. Currently engaged in individual treatment for a mood disorder (assessed by BCC during phone screen)
  8. Currently engaged in a cognitive-behavioral group or therapy (assessed by BCC during phone screen)
  9. Any past psychiatric hospitalizations
  10. Any past suicide attempt or incident of self-harm with moderate or greater lethality
  11. Extreme, current drug/alcohol abuse (determined by clinician follow up following a score of 3 or greater on the CRAFFT)
  12. Current suicidal thoughts

    1. Eligibility will be determined on a case-by-case basis during the baseline PhQ-9 and MINI Kid assessment process and after a consultation with a licensed mental health clinician has taken place. If adolescent report suicidal ideation on the baseline PhQ-9, and found ineligible, the MINI Kid assessment may not be required.
    2. Adolescents with current (within the past 6 months), active suicidal feelings will be excluded.
    3. Adolescents with passive thoughts of death or suicide but report to the mental health clinician that they would never act on these thoughts may be admitted, depending on the severity of the risk.
    4. Adolescents with past (greater than 6 months ago) ideation who are determined to be low risk will be admitted into the study if there has never been an attempt of moderate or greater lethality.
  13. Significant reading impairment (a minimum sixth-grade reading level based on parental report) and/or significant intellectual or developmental disabilities
  14. Not willing to comply with the study protocol
  15. Did not complete phone assessment with MINI Kid by BCC
  16. Not affiliated with any of the sites listed in Appendix A.
  17. Parent/guardian does not speak English or Spanish
  18. Parent/guardian has a cognitive or intellectual impairment
  19. Participant Declined/Changed Mind/Uninterested in participating

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Benjamin W Van Voorhees, MD, MPH 312-996-8352 bvanvoor@uic.edu
Contact: Rebecca T Feinstein, PhD 3129962024 rfeinst@uic.edu

Locations
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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         
Sponsors and Collaborators
University of Illinois at Chicago
Wellesley College
Advocate Health Care
NorthShore University HealthSystem
Ann & Robert H Lurie Children's Hospital of Chicago
University of Chicago
National Institute of Mental Health (NIMH)
Investigators
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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
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Benjamin Van Voorhees, MD, MPH, University of Illinois at Chicago:
Adolescents Depression
Internet intervention
Cognitive-Behavioral Therapy
Prevention
MOST design
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Mental Disorders
Behavioral Symptoms
Mood Disorders