TrialX
Image

PATH 2 Purpose: Primary Care and Community-Based Prevention of Mental Disorders in Adolescents

PATH 2 Purpose: Primary Care and Community-Based Prevention of Mental Disorders in Adolescents

Recruiting
13-18 years
All
Phase N/A

Overview

The study is a two-arm comparative effectiveness research trial to that will evaluate the ability of the interventions, Competent Adulthood Transition with Cognitive-behavioral & Interpersonal Training (CATCH-IT) and Teens Achieving Mastery over Stress (TEAMS), to intervene early to prevent depressive illness and potentially other common mental health disorders. Using cluster randomization, 564 participants eligible for the study will be offered one of two different depression prevention programs in multiple sites in Chicagoland, Rockford, IL; Dixon, IL; and Louisville, KY. The study will also assess teens', parents' and providers' experiences with each intervention approach.

Description

The majority of mental, emotional and behavioral (MEB) disorders have an initial onset before age 24, with 20% annual incidence, with major depressive disorder (MDD) being the most common MEB. Health systems, eager to reduce costs, want to transition from the current "wait until sick enough for treatment" model for MDD to a preventive model. However, evidence is needed for (1) the comparative effectiveness of a "scalable intervention" and (2) an implementation model for such a scalable intervention in the primary care setting. This study is a comparative effectiveness trial evaluating the efficacy of two evidence-based cognitive-behavioral prevention (CBP) programs: Teens Achieving Mastery over Stress (TEAMS), the "gold standard," face-to-face, group therapy model, and Competent Adulthood Transition with Cognitive Behavioral, Humanistic and Interpersonal Training (CATCH-IT), a scalable, self-directed, technology-based model. Using cluster randomization, 564 eligible adolescents age 13-18 will be offered one of two different depression prevention programs in multiple sites in urban and suburban Chicago, IL; rural Western Illinois, including Dixon and surrounding towns; and Louisville, KY. The investigators will comprehensively evaluate patient-centered outcomes and stakeholder-valued moderators of effect at 2, 6, 12, and 18 month assessment points. Using a hybrid clinical trial design that simultaneously examines implementation process, the study will also assess adolescents', parents' and providers' experiences (i.e. efficacy, time commitment, cultural acceptability, and implementation cost) with each intervention approach.

Eligibility

Inclusion Criteria:

  • Adolescents ages 13 through 18 years, and
  • Adolescent must be experiencing an elevated level of depressive symptoms (Patient Health Questionnaire-9 Score = 7-14), and
  • Adolescent will be included if they have a past, but not current history of depression.

Exclusion Criteria:

  • Outside age range
  • A current diagnosis of Major Depression
  • DSM-V diagnosis of: schizophrenia, bipolar affective disorder, extreme current drug or alcohol abuse.
  • Currently using medication therapy for depression, anxiety, or other internalizing disorders.
  • Currently engaged in individual treatment for a mood disorder
  • Currently engaged in a cognitive-behavioral group or therapy
  • Any past psychiatric hospitalizations
  • Any past self-harm attempt with moderate or greater lethality
  • Current suicidal thoughts
  • Not willing to comply with the study protocol
  • Not willing to participate in the TEAMS groups
  • Not willing to be audio recorded during TEAMS groups (only for TEAMS clinics)
  • Unable to complete the PHQ-9 screening due to cognitive or intellectual impairment
  • Did not complete phone assessment with MINI Kid by BCC
  • Not affiliated with any of the P2P PCP or school-based clinic sites
  • Parent/guardian does not speak English
  • Parent/guardian has a cognitive or intellectual impairment.
  • Participant Declined/Changed Mind/Uninterested in participating

Study details
    Endogenous depression
    Depression
    Depression

NCT04290754

University of Illinois at Chicago

16 February 2024

Step 1 Get in touch with the nearest study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team


Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.