Primary Care Internet Based Depression Prevention for Adolescents (CATCH-IT) Also Known as Promoting AdolescenT Health (CATCH-IT)

August 19, 2019 updated by: Benjamin Van Voorhees, MD, MPH

Primary Care Internet Based Depression Prevention for Adolescents (Promoting AdolescenT Health-PATH)

The purpose of this randomized multiple-site clinical study is to determine whether a revised CATCH-IT (Internet-based depression prevention program) is more effective than a general health education Internet intervention (Health Education)on teens ages 13-18 (inclusive). It is hypothesized that teens in CATCH-IT will exhibit lower levels of depressed mood and/or maintain lower depressive scores over 2 years long-term follow up as compared to teens in Health Education group.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Additional aims and hypothesis are provided below:

-Aim 1: To determine whether the CATCH-IT depression prevention intervention prevents or delays major depressive episodes, as well as non-affective disorder episodes, compared to HEALTH EDUCATION.

Hypothesis 1: Compared to youth in the HEALTH EDUCATION condition, youth assigned to CATCH-IT will have a lower hazard ratio of major depressive episodes and non-affective disorder episodes over 2 years.

-Aim 2: To determine if participants in the CATCH-IT group exhibit more rapid favorable changes of depressive symptoms/and or vulnerability/protective factors compared to the HEALTH EDUCATION group.

Hypothesis 2: Compared to youth in the HEALTH EDUCATION condition, youth in the CATCH-IT program will demonstrate a steeper slope of improved symptoms and fewer depressed days over 2 years.

-Aim 3: To determine if participants in the CATCH-IT program report lower perceived educational impairment, greater quality of life, greater health-related quality of life, and lower incidence of other mental disorders (anxiety, substance/alcohol use) as compared to participants in HEALTH EDUCATION.

Hypothesis 3: Compared to youth in the HEALTH EDUCATION group, youth in the CATCH-IT program will demonstrate more rapid benefits in reduced educational impairment, improved quality of life, and fewer disorders over 2 years.

-Aim 4: To determine for whom (moderators)among 13-18 year old (inclusive) and how (mediators) the CATCH-IT program works.

Hypothesis 4.1: CATCH-IT effects will be moderated by six domains: (1) demographic/cultural factors, (2) vulnerability factors/adverse events,(3) motivation,(4) physician relationship, (5) parent/child co-morbid psychopathology, and (6) treatment.

Hypothesis 4.2: The relation between CATCH-IT participation and reduction in depressive episodes will be mediated by adherence to the Internet, motivational interview fidelity as they alter vulnerability factors (e.g. motivation, cognition and social support) and responses to adverse events, which in turn impact the likelihood of episodes.

Exploratory Aim 1: To determine the implementation feasibility of the intervention from the physician/nurse practitioner and office nurse/medical assistant perspective as well as to describe the practices in relationship to the medical home model.

Exploratory Aim 2: To determine whether CATCH-IT has a favorable cost-benefit ratio and/or cost effectiveness of <$50,000/disability adjusted life year compared to the HEALTH EDUCATION group.

Study Type

Interventional

Enrollment (Actual)

1142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois
      • Chicago, Illinois, United States, 60606
        • ACCESS Healthcare Systems
      • Evanston, Illinois, United States, 60201
        • Northshore Healthcare Systems
      • Oak Lawn, Illinois, United States, 60453
        • Advocate Health Care
      • Oak Park, Illinois, United States, 60302
        • Children's Clinic
    • Indiana
      • Dyer, Indiana, United States, 46311
        • Franciscan St. Margaret Health
    • Massachusetts
      • Wellesley, Massachusetts, United States, 02481-8203
        • Wellesley Center for Women

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Adolescents:

(A) Youth ages 13 through 18 who are English speaking. (B) Youth must be experiencing elevated level of depressive symptoms on the Center for Epidemiologic Studies Depression (CES-D) scale (score >/= 16). (C) Youth will be included if they have a past history of depression, anxiety, externalizing symptoms, or substance abuse. Youth presenting in partial remission from a major depressive episode at Baseline will be rescreened after 2 months utilizing the phone screen to ensure episode is fully remitted prior to randomization or access to study intervention. Those who do not fully remit after two months will be excluded.

Parents:

*Parent of eligible adolescents

Physicians (PCP) or NP:

*Physician in any of the study sites

Healthcare Professionals:

*Primary care practice for a minimum of 6 months

Exclusion Criteria:

Adolescents:

  • Current DSM-IV diagnosis of Major Depressive Disorder
  • Current therapy for depression, or be taking antidepressants (e.g., SSRIs, TCAs, MAOIs, bupropion, nefazodone, mirtazapine, venlafaxine);
  • Current CES-D score >35;
  • DSM-IV diagnosis of schizophrenia (current or past) or bipolar affective disorder;
  • Current serious medical illness that causes significant disability or dysfunction;
  • Significant reading impairment (a minimum sixth-grade reading level based on parental report), mental retardation, or developmental disabilities;
  • Serious imminent suicidal risk (as determined by endorsement of current suicide on CES-D or in KSADS interview) or other conditions that may require immediate psychiatric hospitalization
  • Psychotic features or disorders, or currently be receiving psychotropic medication
  • Extreme, current drug/alcohol abuse (greater than or equal to 2 on the CRAFFT).

Parents:

  • Ineligible child
  • Non-English speaking

Physicians:

*None

Healthcare Professionals:

*None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CATCH-IT

200 randomized teens 13-18 year old (inclusive) will be enrolled into the online program that contains 14 modules focused various therapeutic techniques, a booster session of 6 modules at the end of the online program and three 15 minute visits with their primary care doctor to discuss the benefits and disadvantages of the program.

Parents will also be invited to participant in a partnering online program involving 4 modules online and 1 optional module. They will be asked to then participate in three 15 minute interviews with a member of the study team to discuss the benefits and disadvantages of the program.

It contains 14 modules focused on behavioral activation, cognitive behavioral therapy, interpersonal therapy and a resiliency building model, including elements such as narratives, video diaries, skill building exercises and a booster program (not yet initiated) with 6 modules that involves interaction with a live therapist. It also includes three 15-minute meetings with the primary care provider at baseline, 2 months and 12 months post intervention. These meetings are focused on the motivational interview approach where the patient and the doctor talk about the mental/physical health goals of the patient and determine the best approach for the patient by allowing the patient to have full input into the plan.
Other Names:
  • CATCH-IT 2
  • CATCH-IT 3
No Intervention: Health Education

200 randomized teens, ages 13-18 year old (inclusive) receiving an online program with 14 modules that focus on general health education, depression, diet, exercise, hygiene and safety.

Parents will also be invited to participate in an online program with 4 modules that also focus on general health education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Depressive Episode (major and sub-threshold)
Time Frame: 0, 2, 6, 12, 18 and 24 months
Kiddie Schedule of Affective Disorders Scale (KSADS) used to evaluate for current and past depressive episode at each time point (interval between time points). Occurrence of first depressive episode was determined by the Depression Symptom Rating (DSR). We considered a score indicating at least sub-threshold major depression (a DSR of ≥3+) to be a depressive episode. DSR 4 and above and 5 alone will also be assessed.
0, 2, 6, 12, 18 and 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressed mood
Time Frame: 0, 2, 6, 12, 24 months
The Center for Epidemiological Studies of Depression(CES-D)Scale -Change in CES-D score between groups (CATCH-IT & HEALTHED) across the duration of the study and for each assessment point
0, 2, 6, 12, 24 months
Vulnerability Factors
Time Frame: 0, 2, 6, 12, 18, 24 months
Sibling Inventory of Differential Experience, (SIDE), Child/Parent Report of Parental Behavior Inventory (CRPBI - teen and parent), Conflict Behavior Questionnaire (CBQ - teen and parent), Beck Hopelessness Scale, Adolescent Life Events Questionnaire (ALEQ) (not all measures at all time points)
0, 2, 6, 12, 18, 24 months
Quality of Life, educational impairment and other mental disorder symptoms or episodes
Time Frame: 0, 2, 6, 12, 18, 24 months
Masten's Status Questionnaire,World Health Organization (WHO) Quality of Life Scale , Educational Impairment Scale, Change in scales of SCARED, Disruptive Behavior Disorder Scale (DBD - teen and parent), CRAFFT (substance abuse), SCARED (anxiety), Global Assessment Scale (GAS, assessor scores from KSADS responses) scores (not all measures at all time points).
0, 2, 6, 12, 18, 24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to Internet Use
Time Frame: continous measure
Counting the number of logs/subject (over 2 years), number of characters typed, number of clicks in each page, time spent on each session and total time spent online and Socio-cultural Relevance Scale.
continous measure
Implementation
Time Frame: 0, 2, 24 months
Changes in perceived feasibility and implementation of the study from the healthcare professionals (physicians, nurse and leaders)from baseline to the completion of the study at 24 months.
0, 2, 24 months
Motivation (adolescent)
Time Frame: 0,2,12 months
Theory of Planned Behavior Scale, Trans-Theoretical Model Scale
0,2,12 months
Demographic Information
Time Frame: 0,2,6,12,24 months
assesses age, height, weight, contact information, race, ethnicity, home demographics, educational level of parents.
0,2,6,12,24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Benjamin Van Voorhees, MD, MPH, UIC
  • Principal Investigator: Tracy Gladstone, PHD, Wellesley Center for Women

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

June 5, 2012

First Submitted That Met QC Criteria

July 2, 2013

First Posted (Estimate)

July 9, 2013

Study Record Updates

Last Update Posted (Actual)

August 22, 2019

Last Update Submitted That Met QC Criteria

August 19, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2011-0505
  • 1R01MH090035-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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