The PATHway Study: Primary Care Based Depression Prevention in Adolescents

Running, not enrolling · Not applicable

Conditions studied: Depression, Mental Disorder in Adolescence

In brief

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.

Key facts

Study ID

NCT05203198

Run by

University of Illinois at Chicago

People needed

400

Starts

2022-02-01

Expected to finish

2026-10-31

Last updated by the study team

2026-06-22

Who can join

Age: 13 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• 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

Where it is running

• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• UI Health — Chicago, Illinois, United States
• University of Chicago Comer Children's Hospital — Chicago, Illinois, United States
• Northshore University HealthSystem — Glenview, Illinois, United States
• Advocate Aurora Health — Park Ridge, Illinois, United States
• UT Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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