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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Illinois at Chicago
Sponsor:
Collaborators:
Wellesley College
Northwestern University
Harvard Vanguard Medical Associates
Access Healthcare Systems
NorthShore University HealthSystem Research Institute
Mile Square Health Center
The Children's Clinic
Information provided by (Responsible Party):
Benjamin Van Voorhees, MD, MPH, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT01893749
First received: June 5, 2012
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Major Depression
Depressive Episodes
Behavioral: CATCH-IT

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Primary Care Internet Based Depression Prevention for Adolescents (Promoting AdolescenT Health-PATH)

Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • The Center for Epidemiological Studies of Depression(CES-D)Scale [ Time Frame: 0, 2, 6, 12, 18 and 24 months ] [ Designated as safety issue: Yes ]
    Change in CES-D score from baseline Change in CES-D score between groups (CATCH-IT & HEALTHED)across the duration of the study and for each assessment point


Secondary Outcome Measures:
  • Kiddie Schedule of Affective Disorders Scale(KSADS) [ Time Frame: 0, 2, 6, 12, 24 months ] [ Designated as safety issue: Yes ]
    Screening for current and past psychiatric diagnosis at each time point to ensure eligibility is consistent throughout the study (certain psychiatric diagnosis might render a subject ineligible for the study, therefore a KSADS interview is conducted at each major assessment point)

  • Vulnerability Factors [ Time Frame: 0, 2, 6, 12, 24 months ] [ Designated as safety issue: No ]
    Change in scales of Automatic Negative Thoughts, Perceived Family and Social Support Scales, Beck's Hopelessness Scale, CRAFFT, Social Adjustment Scale, Theory of Planned Behavior Scale, Transtheoretical Model measure, Adolesecent Life Events scale, Disruptive Behaviors Scale, SCARED (Self-Report for Childhood Anxiety Related Emotional Disorders) measure, and Sibling Inventory of Differential Experience for each assessed time point within and between groups


Other Outcome Measures:
  • Adherence to Internet Use [ Time Frame: continous measure ] [ Designated as safety issue: No ]
    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.

  • Implementation [ Time Frame: 0, 2, 24 months ] [ Designated as safety issue: No ]
    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.

  • Motivational Interview Pre-Measure [ Time Frame: 0,2,12 months ] [ Designated as safety issue: No ]
    This measure is administered to adolescents prior to meeting with the physician for a motivational interview. It contains items asking adolescents to identify goals for the intervention, consider how they are feeling and their degree of motivation to change their feelings, and their willingness to engage in the present intervention. This is an optional measure

  • Demographic Information [ Time Frame: 0,2,6,12,24 months ] [ Designated as safety issue: No ]
    assesses age, height, weight, contact information, race, ethnicity, home demographics, educational level of parents.


Estimated Enrollment: 800
Study Start Date: February 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CATCH-IT

200 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.

Behavioral: CATCH-IT
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 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 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.


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.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Adolescents:

  • Ages 13 through 18 (inclusive)
  • English-speaking
  • CES-D scale score >/= 16 if had previous history of depression and score >/=20 if had no previous experience with depression and have at least two core symptoms of Major Depression
  • Past history of depression, anxiety, externalizing symptoms, or substance abuse.

Parents:

*Parent of eligible adolescents

Physicians (PCP):

*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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01893749

Contacts
Contact: Jennifer Nidetz, MSW, LCSW 312-996-0407 jnidetz@uic.edu
Contact: Monika Marko, MSS 312-413-1165 mmarko@uic.edu

Locations
United States, Illinois
ACCESS Healthcare Systems Recruiting
Chicago, Illinois, United States, 60606
Contact: Jennifer Nidetz, MSW, LCSW    312-996-0407    jnidetz@uic.edu   
Sub-Investigator: Mickey Eder, PHD         
University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: Monika Marko, MSS    312-413-1165    mmarko@uic.edu   
Sub-Investigator: Florence Desrosiers, MD         
Northshore Healthcare Systems Recruiting
Evanston, Illinois, United States, 60201
Contact: Jennifer Nidetz, MSW, LCSW    312-996-0407    jnidetz@uic.edu   
Sub-Investigator: Jason Canel, MD         
Children's Clinic Recruiting
Oak Park, Illinois, United States, 60302
Contact: Elizabeth Lippitt       elippitt@childrenscliniciws.org   
Principal Investigator: Benjamin Van Voorhees, MD, MPH         
United States, Massachusetts
Wellesley Center for Women Recruiting
Wellesley, Massachusetts, United States, 02481-8203
Contact: Tracy Gladstone, PHD    781-283-2558    tgladsto@wellesley.edu   
Principal Investigator: Tracy Gladstone, PHD         
Sponsors and Collaborators
Benjamin Van Voorhees, MD, MPH
Wellesley College
Northwestern University
Harvard Vanguard Medical Associates
Access Healthcare Systems
NorthShore University HealthSystem Research Institute
Mile Square Health Center
The Children's Clinic
Investigators
Principal Investigator: Benjamin Van Voorhees, MD, MPH UIC
Study Director: Jennifer Nidetz, MSW, LCSW UIC
Principal Investigator: Tracy Gladstone, PHD Wellesley Center for Women
  More Information

No publications provided

Responsible Party: Benjamin Van Voorhees, MD, MPH, Associate Professor of Medicine, Chief, Section of General Pediatrics and Adolescent Medicine, TIKES Center Director, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT01893749     History of Changes
Other Study ID Numbers: 1 RO1 MH090035-01A1
Study First Received: June 5, 2012
Last Updated: April 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Illinois at Chicago:
depression
prevention
teen
at risk
internet

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on November 20, 2014