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DepressionP2PNCT04290754

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

A study testing CATCH-IT and TEAMS in people with Depression, run by University of Illinois Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

PATH (Promoting AdolescenT Health) 2 Purpose 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… Read more about this study

Who is it for?
Ages 13 to 19 yearsHealthy volunteers can take part
Conditions the study is for
Depression
What is being tested?
CATCH-IT and TEAMS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
636 participants
Where
1 siteUnited States
Study dates
1 Jan 2020to 1 Oct 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 19 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Adolescents ages 13 through 19 years, and
  • Adolescent must be experiencing an elevated level of depressive symptoms (Patient Health Questionnaire-9 Score = 5-18), and
  • Adolescent will be included if they have a past, but not current history of depression.

Who cannot join

  • Outside age range
  • A current diagnosis of Major Depression
  • Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (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 for less than 3 months.
  • Currently engaged in individual treatment for a mood disorder
  • Currently engaged in a cognitive-behavioral group or therapy
Show all 16Show fewer
  • 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
  • Parent/guardian has a cognitive or intellectual impairment.
  • Participant Declined/Changed Mind/Uninterested in participating

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UI Health

    Chicago, Illinois, 60612

Other trials in United States

About this study

PATH (Promoting AdolescenT Health) 2 Purpose 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, 534 participants eligible for the study will be offered one of two different depression prevention programs in multiple sites in Chicagoland, Rockford, Illinois; Dixon, Illinois; and Louisville, Kentucky. In response to the Coronavirus Disease 2019 (COVID-19) pandemic, we will employ a public health media campaign to recruit a second cohort of 100 adolescents state-wide in Illinois, Kentucky, and Massachusetts individually randomized to either intervention. The study will also assess teens', parents' and providers' experiences with each intervention approach. Finally, we will examine the impact of the COVID-19 pandemic on adolescents at-risk for depression who are enrolled in our study.

Read the detailed 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," group therapy model, and Competent Adulthood Transition with Cognitive Behavioral, Humanistic and Interpersonal Training (CATCH-IT), a scalable, self-directed, technology-based model. For implementation during the COVID-19 pandemic, TEAMS has successfully been adapted to an online format and administered online through HIPAA-compliant video conferencing software. For the first cohort, 534 eligible adolescents age 13-19 will be offered one of two different depression prevention programs using cluster randomization in multiple sites in urban and suburban Chicago, Illinois; rural Western Illinois, including Dixon and surrounding towns; and Louisville, Kentucky. Randomization will be blocked into matched pairs of primary health care clinics and school sites and stratified by race, ethnicity, rural-urban commuting area codes, and socio-economic disadvantage using the Distressed Communities Index (DCI) from census-tracked data of each site zip code. A second cohort of 100 eligible adolescents will be recruited through public health media campaigns in Illinois, Kentucky, and Massachusetts utilizing the same eligibility criteria as Cohort One. These participants will connect with the research team by phone, email, web survey, or social media and will be randomized at the individual-level with equal allocation into treatment conditions (CATCH-IT or TEAMS). 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. A sub-sample of Cohort Two (n=50, 25 from each intervention arm) will be recruited to participate in open-ended interviews for adolescents to share their experiences of living with subsyndromal depression, coping during the COVID-19 pandemic, their perceived impact of CATCH-IT or TEAMS on their mood and behavior, and the cultural contexts in which these experiences occurred.

Conditions
Depression
Being tested
CATCH-IT, TEAMS
Keywords
Adolescents, Depression, Internet intervention, Cognitive-Behavioral Therapy, Prevention, Group Therapy
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CATCH-ITBehavioural

    Competent Adulthood Transition with Cognitive-behavioral \& Interpersonal Training (CATCH-IT) is an internet-based depression prevention program that targets decreasing modifiable risk factors while enhancing protective factors in at-risk adolescents, and that includes a parent program. It has been shown to be safe, feasible, and efficacious.

  • TEAMSBehavioural

    Also called Prevention of Depression (POD)

    Teens Achieving Mastery over Stress (TEAMS) is an 8-session group depression prevention program teaching teens how to deal with stress and negative moods, and ways to manage low mood based on cognitive behavioral therapy (CBT) principles and strategies. Efficacy has been demonstrated by several trials over time.

Study groups in NCT04290754
Study groupRoleWhat they receive
CATCH-ITExperimentalCompetent Adulthood Transition with Cognitive-behavioral \& Interpersonal Training (CATCH-IT) is an internet-based depression prevention program that targets decreasing modifiable risk factors while enhancing protective factors in at-risk adolescents, and that includes a parent program. It has been shown to be safe, feasible, and efficacious.
Receives: Behavioral: CATCH-IT
TEAMSActive comparatorTeens Achieving Mastery over Stress (TEAMS) is an 8-session group depression prevention program teaching teens how to deal with stress and negative moods, and ways to manage low mood based on cognitive-behavioral therapy (CBT) principles and strategies. Efficacy has been demonstrated by several trials over time.
Receives: Behavioral: TEAMS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time

    Time will be measured to nearest minute for all intervention related activities including initial screening, engagement phone calls, use of CATCH-IT, TEAMS group activities, including travel time to and from TEAMS groups. 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.

    Measured: Baseline through 18 months

  2. Cultural acceptability adolescent and family

    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."

    Measured: Baseline through 18 months

  3. Cost

    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 an 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).

    Measured: Baseline through 18 months

  4. Depressive and mental disorder episodes

    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.

    Measured: Baseline through 18 months

  5. Stress symptoms

    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)

    Measured: Baseline through 18 months

  6. Resiliency

    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)

    Measured: Baseline through 18 months

  7. Function

    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.

    Measured: Baseline through 18 months

  8. Relationships (Life Events)

    University of California at Los Angeles (UCLA) Life Events Scale (19-items, self-report) administered to adolescents only.

    Measured: Baseline through 18 months

  9. Socio-cultural Relevance

    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)

    Measured: Baseline through 18 months

  10. Organizational Readiness to Change Assessment

    Organizational Readiness to Change Assessment (ORCA, 18 questions, 4 items per question, self-report, 5-point Likert scale, 18-90 score range, higher score indicates higher organizational readiness, component of cultural acceptability to practice, community center, healthcare organizations, health systems)

    Measured: Baseline

  11. Intervention Sustainability

    Program Sustainability Assessment Tool (PSAT, 8 questions, self-report 5 items per question, 7-point Likert scale, 8-56 score range, higher score indicates higher capacity for program sustainability, component of cultural acceptability to practice, community center, healthcare organizations, health systems)

    Measured: end of study, 30 months

  12. Acceptability of Intervention

    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)

    Measured: end of study, 30 months

  13. Feasibility of Intervention

    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)

    Measured: end of study, 30 months

  14. Intervention Appropriateness

    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)

    Measured: Baseline through 18 months

  15. Depressive Symptoms

    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)

    Measured: Baseline through 18 months

  16. Externalizing Behavior Symptoms

    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)

    Measured: Baseline through 18 months

  17. Anxiety Symptoms

    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)

    Measured: Baseline through 18 months

  18. Substance Abuse Symptoms

    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)

    Measured: Baseline through 18 months

  19. Post Traumatic Stress Disorder Symptoms

    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)

    Measured: Baseline through 18 months

  20. Rumination

    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)

    Measured: Baseline through 18 months

  21. Dysfunctional Attitudes

    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)

    Measured: Baseline through 18 months

  22. Relationships-Family

    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).

    Measured: Baseline through 18 months

  23. Blood Pressure

    Measured in millimeters of mercury

    Measured: Baseline and 18 months

  24. Body Mass Index

    Calculated by measuring height (centimeters) and weight (kilogram) to calculate kg/meters squared (BMI, Body Mass Index)

    Measured: Baseline and 18 months

  25. Weight

    Measured in kilograms by standard medical office scale, fully clothed participant

    Measured: Baseline and 18 months

  26. Height

    Measure by standard medical office practice measure, without shoes, in centimeters

    Measured: Baseline and 18 months

  27. Recruiting model and comparative effectiveness outcomes

    With the addition of a second cohort to be recruited through a public health media campaign, we will compare results between groups in each arm, and between the two recruitment models. We will compare implementation and clinical outcomes in the same trial arm, but also across the two recruiting methods.

    Measured: Baseline through 18 months

Secondary outcomes (2)
  1. Implementation themes

    Consolidated Framework for Implementation Research (CFIR) will be used to explore experience of the study from the perspective of 25 stakeholders

    Measured: End of study, 30 months

  2. Moderation of Covid-19 factors on comparative effectiveness outcomes

    We will examine factors related to the COVID-19 pandemic that may be moderators of study outcomes: (1) COVID-19-related behaviors and consequences (e.g. social distancing, sheltering-in-place, family illness and death), and (2) Social determinants of health (e.g. food insecurity, internet access, unemployment) in both cohorts using the Holliston at-Home Questionnaire (a 26-item, adolescent self-report, 5-point Likert scale, 0-150 score range, higher score indicates greater externalizing symptoms).

    Measured: Baseline through 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2020
  2. Study start1 Jan 2020
  3. Primary completion1 Jul 2026
  4. Study completion1 Oct 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Comparative Effectiveness Study
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
636 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04290754
Sponsor's protocol ID
CHAIRb 19081501
Other IDs
IHS-2017C3-9333, 094637
Acronym
P2P
Status last verified
Oct 2026
First submitted
10 Feb 2020
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Knepper AK, Feinstein RT, Sanchez-Flack J, Fitzgibbon M, Lefaiver C, McHugh A, Gladstone TRG, Van Voorhees BW. Primary care-based screening and recruitment for an adolescent depression prevention trial: Contextual considerations during a youth mental health crisis. Implement Res Pract. 2024 Apr 22;5:26334895241246203. doi: 10.1177/26334895241246203. eCollection 2024 Jan-Dec.

    PubMed 38655380

Questions about this trial

What is this clinical trial studying?

A study testing CATCH-IT and TEAMS in people with Depression, run by University of Illinois Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time (time frame: Baseline through 18 months). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04290754, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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