Status:
ACTIVE_NOT_RECRUITING
The PATHway Study: Primary Care Based Depression Prevention in Adolescents
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
Wake Forest University Health Sciences
Endeavor Health
Conditions:
Depression
Mental Disorder in Adolescence
Eligibility:
All Genders
13-18 years
Phase:
NA
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...
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). Unfort...
Eligibility Criteria
Inclusion
- 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
- 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
- Parent/guardian has a cognitive or intellectual impairment
- Participant Declined/Changed Mind/Uninterested in participating
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT05203198
Start Date
February 1 2022
End Date
October 31 2026
Last Update
January 8 2026
Active Locations (6)
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1
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
2
UI Health
Chicago, Illinois, United States, 60612
3
University of Chicago Comer Children's Hospital
Chicago, Illinois, United States, 60637
4
Northshore University HealthSystem
Glenview, Illinois, United States, 60026