PATH 2 Purpose

Primary Care and Community-Based Prevention of Mental Disorders in Adolescents

Contact our Call Center for more information:

Phone: 1-877-268-PATH (7284)

or

Email: [email protected]

Participate in P2P

 

The PATH 2 Purpose (P2P) study is a free, voluntary program for teenagers who want to get improve their mood and learn coping skills to manage difficult situations. Pioneered by leading universities, the P2P study is a clinical trial that will determine how best to help teens build healthy lifestyles and prevent feeling down.

You may be referred to the study by your primary care provider (PCP).

If you choose to participate, you will visit with members of our research team who will talk to you about the study. Teens and their parents will be asked to participate in one of two different groups: Teenagers in the CATCH-IT group will work on an online program at their own pace and in complete privacy, and teenagers in the TEAMS group meet online with about 6-10 other teenagers and a group leader, once a week for eight weeks and then once a month for 6 months. You do not have to take any medications or talk about things you don’t want to. During the 18 months of the study, you’ll get regular phone calls from a team member to see how things are going in the program.

 

In both TEAMS and CATCH-IT, teens will learn strategies to cope with negative thoughts, to manage conflicts with friends and family, and to plan for major life changes.

Which group you will get to be in is determined by where you see your family’s primary care provider. Some health clinics will offer the CATCH-IT group and some will offer the TEAMS group. Both programs offer important information about staying healthy and managing stress. Regardless of which program you get, it is important for you to keep track of changes in your mood. You should always seek help from a PCP or other professional if you feel you may be getting depressed.

 

Who We Are.

We are a team of PCPs, psychologists, writers, researchers, and computer programmers at the UI Health/Advocate Health/KSB Hospital/University of Louisville. We work together to find a way to help promote health and well-being in teenagers.

The Study Includes

  • Access to a computer-based program or an in-person group program for teens
  • Parent interventions
  • A few meetings with our research team
  • Periodic phone calls from our research team
  • Compensation for your time and efforts

What You’ll Learn.

The P2P study can teach you to have a healthy lifestyle so that you will be able to better face the challenges you meet in your everyday life. It’s fun to be a teenager, but of course teenagers also experience a lot of stress. Some of us are better than others at managing that stress. The P2P study has two different programs that are designed to help teenagers develop healthy life habits and deal with the stressful things in their lives.

Frequently Asked Questions

How much trouble is it to complete the study?

The study has been designed to be as easy as possible. You don’t have to take any pills, and you don’t have to talk about anything you don’t want to. And while you have to apply what you learn in the study in real life to get the most out of it, the P2P study isn’t just like homework. You can use the skills you learn in the P2P study to change your life. Over the course of 18 months, you and your teen will be asked to participate either the CATCH-IT or TEAMS program, and be called for interviews every six months.

What if I don’t want other people to know?

What you tell your friends and family is entirely up to you. Your friends and family could be a big source of support as you go through this study. Any information about your participation is kept private.

What are the risks of the study?

  • You and your teen could experience distress or discomfort when answering questions about feelings and behavior.
  • While we make every effort to keep your personal health information private and confidential complete confidentiality cannot be guaranteed.

If your teen is eligible, and you allow your teen to participate, you and your teen are free to withdraw from the study at any time.

How can I find out more about P2P? Contact our Call Center for more information.

Phone: 1-877-268-PATH (7284)  or  Email: [email protected]

CATCH-IT

The CATCH-IT internet-based program teaches teens how to deal with feeling sad and down, and ways to manage these moods. CATCH-IT stands for Competent Adulthood Transition with Cognitive-behavioral & Interpersonal Training.

In CATCH-IT, teens will learn strategies to cope with negative thoughts, to manage conflicts with friends and family, and to plan for major life changes. It is important for you to keep track of changes in your mood. You should always seek help from a PCP or other professional if you feel you may be getting depressed.

 

For Parents. This program helps parents to learn about what their teens are learning, and about what steps they can take to promote well-being.

  • In the CATCH-IT group, parents will get instructions to visit the internet site specifically for parent

How can I find out more about CATCH-IT? Contact our Call Center for more information:

Phone: 1-877-268-PATH (7284)

or

Email: [email protected]

TEAMS

The TEAMS group is an in-person group that will meet for 8 sessions in a row, and then 6 more sessions over 6 months. Teenagers in the TEAMS group will be in a group with about 6-10 other teenagers, and there will be a team member there to help lead the group. TEAMS stands for Teens Achieving Mastery over Stress.

In TEAMS, teens will learn strategies to cope with negative thoughts, to manage conflicts with friends and family, and to plan for major life changes. It is important for you to keep track of changes in your mood. You should always seek help from a PCP or other professional if you feel you may be getting depressed.

For Parents. This program helps parents to learn about what their teens are learning, and about what steps they can take to promote well-being.

  • In the TEAMS group, parents will be invited to participate a specific group session for parents with the group leader.

How can I find out more about TEAMS? Contact our Call Center for more information:

Phone: 1-877-268-PATH (7284)  or  Email: [email protected]

P2P in the Community

Why is this study important?

Prevalence of depression in teens:

  • 1 in 5 young people have at least one mental, emotional, and behavioral (MEB) disorder, including depression.
  • Nearly 50% of children with a MEB disorder also experience significant challenges with their social, mental, or emotional development, which is associated with poorer physical health.
  • Given the high rates of youth depression and the long-term effects associated with depression, efforts to prevent depressive disorders in adolescents will have valuable implications for population health.

Gaps in knowledge

  • We have no strategy to deliver evidence-based depression prevention approaches to the teen population.

PATH 2 Purpose

  • The PATH 2 Purpose study will enroll teens at risk for depression into two different prevention programs, Teens Achieving Mastery over Stress (TEAMS) and Competent Adulthood Transition with Cognitive-behavioral and Interpersonal Training (CATCH-IT), and compare their effectiveness.

The Challenge

  1. Widely implement effective, evidenced-based mental health interventions in primary care clinics and schools;
  2. Successfully adapt the interventions for use in diverse communities; and
  3. Create a sustainable system for the interventions to be used in a population-health model

The Intervention Programs

  • TEAMS: 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.
  • CATCH-IT: 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.

Study Design:

  • The study is a two-arm comparative effectiveness research trial that will evaluate the ability of the interventions, TEAMS and CATCH-IT, to intervene early to prevent depressive illness, accessibility, time commitment, cultural acceptability, and implementation costs.
  • 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.

Who is eligible?

Adolescents ages 13-18 years, all genders, English speaking, and have elevated symptoms of depression, or depression and anxiety, as indicated by PHQ-9 score. Recruitment sites will be diverse in socio-economic status and racial/ethnic representation.

Who is not eligible?

Adolescents who currently use psychotropic medication, medication or therapy for depression or bipolar affective disorder, are currently experiencing psychosis or extreme substance abuse, or read below a fifth grade level. Teens will be screened for participation at the recruitment site and/or can contact the study call center directly.

Staff and Collaborators

This study is funded by:

Patient-Centered Outcomes Research Institute (www.pcori.org)

(PCORI) Award (IHS-2017C3-9333).

OUR TEAM

Principal Investigators:

Benjamin Van Voorhees, MD, MPH, Department of Pediatrics, UI Health; [email protected]

Tracy Gladstone, PhD, Wellesley University, [email protected]

 

Project Director:

Rebecca Feinstein, MPH, MSW, PhD, Department of Pediatrics, UI Health, [email protected]

 

Co-Investigator Partners:

University of IL, Chicago (http://pediatrics.uic.edu):

University of IL, Rockford (http://rockford.medicine.uic.edu):

University of Louisville, KY (http://louisville.edu/education)

Advocate Health Care (www.advocatehealth.com):

Jericho Walk Chicago (www.jerichowalk.com): Bishop Connie Bansa and Sabrina King

For Researchers

Background and Significance:

  • Depression: Given the high rates of youth depression and the long-term impairment associated with depression, efforts to prevent depressive disorders in adolescents have tremendous implications for population health.
  • Mental, Emotional, and Behavioral (MEB) Disorders in Adolescents: One in five young people have at least one MEB disorder at any point. Nearly 50% of children with an MEB disorder also have significant impairment in their social, cognitive, or emotional development, which is associated with poorer physical health. We have no strategy to deliver evidence-based depression prevention approaches to the adolescent population, nor do we have data on their acceptability. The challenge is to widely implement effective evidenced-based mental health interventions in primary care, which are sustainable past the study phase, and make them successfully adaptable in diverse communities.

Study Aims:

  • Aim 1: Evaluate the willingness and ability of our community partners to implement two depression early intervention/prevention models in primary care: TEAMS and CATCH-IT
  • Aim 2: Evaluate the efficacy of each intervention in decreasing symptoms of depression in adolescents ages 13-18 identified through primary care, and decrease the percentage of individuals falling above an accepted clinical diagnostic threshold on the scales that measure these illnesses.
  • Aim 3: Evaluate the comparative effectiveness of each intervention for African Americans, Latinos, sexual/gender minority youth, males and females, rural youth and for individuals above and below the accepted diagnostic thresholds for these illnesses.
  • Secondary Aim 1: Evaluate the efficacy of each intervention in decreasing symptoms of substance abuse, anxiety disorder, and conduct disorders in adolescents ages 13-18.
  • Secondary Aim 2: Examine possible mediators and moderators of intervention response, including demographic variables, family history, treatment expectations, life events, and trauma history.

Study Design:

  • This study is a two-arm comparative effectiveness randomized clinical trial to evaluate each intervention’s ability to intervene early to prevent depressive illness, and teens’, parents’ and providers’ experiences with each intervention approach. Using cluster randomization, participants will be offered the program assigned to their site. Inclusion: ages 13-18 years, all genders, English speaking, and have elevated symptoms of depression, as indicated by PHQ-9 score. Recruitment sites will be diverse in socio-economic status and racial/ethnic representation. Exclusion: 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; or any past self-harm attempt with moderate or greater lethality.

Analysis:

We will conduct both main effect and moderation analyses to examine whether POD and CATCH-IT are equivalent. The experimental design is a 2 Groups (POD vs. CATCH-IT)  5 Times of measurement (0 baseline, 2, 6, 12, and 18 months) repeated measures design. The design allows main effect tests of Group mean differences combining Times (1 d.f. G), Time mean differences combining Groups (4 d.f. T), scientific interest centers on the G  T interactions (4 d.f.) which permit testing differences in trend lines (linear, quadratic) between groups and group differences in change from baseline or between times. Moreover, by introducing patient subgroups (S), it is possible to examine 3-way interactions (G  T  S) to study heterogeneity of treatment effects (HTE).

  • Aim 1: We will use standard t-tests, or as appropriate, non-parametric tests to compare POD and CATCH-IT regarding domains of stakeholder experience (time, cultural acceptability, and implementation cost).
  • Aim 2: We will estimate incidence rates by calculating the number of depressive episodes per 10,000 person-weeks by 18 months. Kaplan-Meier curves will be used to estimate the time to first episode according to each intervention and will be compared with the log-rank test. We will use linear mixed effect growth models to examine (1) individual level changes in CES-D and other MEB.
  • (Secondary Aim 1) symptoms over time and (2) whether this association differs between intervention groups. All linear mixed models will be adjusted for the covariates listed under Aim 3.
  • Aim 3 (and Secondary Aim 2): We will examine possible moderating effects of risk factors, geographic location, ethnicity, gender, sexual/gender minority status, race, baseline parent CES-D, baseline teen CES-D by including interaction terms in the Cox models (depressive disorder only) and growth curve models. Analyses will be conducted using R, version 3.3.1 (cran.r-project.org), SAS, version 9.4 (SAS Institute, Cary, NC), and Mplus version 8 (statmodel.com). To maximize power in this comparative effectiveness study, we will follow procedures developed from a recent individual level synthesis project  involving multiple randomized preventive trials for adolescent depression that we have conducted.

Outcomes

All measures have been found to have strong psychometric properties and measure domains repeatedly stated by adolescents and families to be personally relevant – including resiliency, quality of life and we expect a relatively small difference in the average trajectories on depressive symptoms as the primary outcome IT standard deviation of the slopes.  We used the RMASS program and verified this with a simulation using R program to compute power based on this design with unequal spacing. We defined non-inferiority as absolute risk of depressive episodes within 8.48 % of the estimated prevalence the TEAMS trial arm of 32.1% after 18 months, that is, CATCH-IT achieving 50% of the risk reduction of TEAMS based on its low burden and cost. We will conduct cox proportional hazards models with covariates and frailty models (time to depressive episode) and growth curve (depression and functional status). Assuming 5% loss to follow-up at each time point, we require N = 564 for the 2-arm study. We will also examine variation in impact, emphasizing a test of moderation by baseline level of symptoms as well as membership in key demographic groups such as AA, Latino, LGBTQ youth and rural whites (Aim 2). To examine differential benefit of one intervention versus the other, we will test for an interaction between intervention, time, and initial level of symptoms, conducted with Mplus.

Publications

Phase 3 Clinical Trial related papers 2011-2018

  • Van Voorhees BW, Gladstone T, Cordel S, Marko-Holguin M, Beardslee W, Kuwabara S, Kaplan MA, Fogel J, Diehl A, Hansen C, Bell C, (2015). Development of a technology-based behavioral vaccine to prevent adolescent depression: A health system integration model. Internet Interventions. 2:303-313
  • Gladstone T.R.G., Terrizzi D.A., Stinson A, Nidetz J, Canel J, Ching E, Berry AD, Cantorna J, Fogel J, Eder M, Bolotin M, Thomann LO, Griffith K, Ip P, Aaby DA, Brown CH, Beardslee W, Bell C, Crawford TJ, Fitzgibbon M, Schiffer L, Liu N, Marko-Holguin M, Van Voorhees BW, (2018). Effect of Internet-Base Cognitive Behavioral Humanistic and Interpersonal Training vs Intenet-based General Health Education on Adolescent Depression in Primary Care: A Randomized Clinical Trial. Jama Network Open. 1(7), e184278-e184278.
  • Ip P, Chim D, Chan KL, Li TM, Ho FK, Van Voorhees BW, Tiwari A, Tsang A, Chan CW, Ho M, Tso W, Wong WH (2016). Effectiveness of a culturally attuned Internet-based depression prevention program for Chinese adolescents: A randomized controlled trial. Depress Anxiety. 33(12):1123-1131

Phase 2 clinical trial related papers 2007-2011

  • Richards K, Marko-Holguin M, Fogel J, Anker L, Ronayne J, Van Voorhees BW, (2016). Randomized clinical trial of an Internet-based intervention to prevent adolescent depression in a primary care setting (CATCH-IT): 2.5-year outcomes. Journal of Evidence-Based Psychotherapies. 16(2):113-134.
  • Kruger JR, Kim P, Iyer V, Marko-Holguin M, Fogel J, DeFrino D, Gladstone T, Van Voorhees BW, (2017). Evaluation of protective and vulnerability factors for depression following an Internet-based intervention to prevent depression in at-risk adolescents. International Journal of Mental Health Promotion. 19(2):69-84.
  • Dickter, B., Bunge, E. L., Brown, L. M., Leykin, Y., Soares, E. E., Van Voorhees, B., ... & Gladstone, T. R. (2019). Impact of an online depression prevention intervention on suicide risk factors for adolescents and young adults. mHealth, 5

International adaptations:

  • Abuwalla Z, Kadhem Z, Bishay A, Gladstone T, Mikhael E, Van Voorhees BW, (2017). Proposed model for the cultural adaptation of an Internet-based depression prevention intervention (CATCH-IT) for Arabic adolescents. International Journal of Adolescent Medicine and Health. https://doi:10.1515/ijamh-2016-0147.
  • Sobowale K, Zhou N, Van Voorhees BW, Stewart S, Tang A, Ip P, Fabrizio C, Wong KL, Chim D, (2013). Adaptation of an Internet-based depression prevention intervention for Chinese adolescents: from “CATCH-IT” to “Grasp the Opportunity.” International Journal of Adolescent Medicine and Health. 25(2):127-37.

Publications in Media:

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This study is funded by:

Patient-Centered Outcomes Research Institute (www.pcori.org)