Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01893749
Recruitment Status : Completed
First Posted : July 9, 2013
Last Update Posted : August 22, 2019
Sponsor:
Collaborators:
Wellesley College
Northwestern University
Harvard Vanguard Medical Associates
Access Healthcare Systems
NorthShore University HealthSystem
Infant Welfare Society
Advocate Health Care
Franciscan St. Margaret Health - Franciscan Alliance
Information provided by (Responsible Party):
Benjamin Van Voorhees, MD, MPH, University of Illinois at Chicago

Tracking Information
First Submitted Date  ICMJE June 5, 2012
First Posted Date  ICMJE July 9, 2013
Last Update Posted Date August 22, 2019
Study Start Date  ICMJE February 2012
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 2, 2013)
The Center for Epidemiological Studies of Depression(CES-D)Scale [ Time Frame: 0, 2, 6, 12, 18 and 24 months ]
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2019)
  • 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
  • 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)
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2013)
  • Kiddie Schedule of Affective Disorders Scale(KSADS) [ Time Frame: 0, 2, 6, 12, 24 months ]
    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 ]
    Change in scales of Automatic Negative Thoughts, Perceived Family and Social Support Scales, Beck's Hopelessness Scale, CRAFFT and Sibling Inventory of Differential Experience for each assessed time point within and between groups
Current Other Pre-specified Outcome Measures
 (submitted: August 19, 2019)
  • 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.
  • 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.
  • Motivation (adolescent) [ Time Frame: 0,2,12 months ]
    Theory of Planned Behavior Scale, Trans-Theoretical Model Scale
  • Demographic Information [ Time Frame: 0,2,6,12,24 months ]
    assesses age, height, weight, contact information, race, ethnicity, home demographics, educational level of parents.
Original Other Pre-specified Outcome Measures
 (submitted: July 2, 2013)
  • 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.
  • 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.
 
Descriptive Information
Brief Title  ICMJE Primary Care Internet Based Depression Prevention for Adolescents (CATCH-IT) Also Known as Promoting AdolescenT Health
Official Title  ICMJE Primary Care Internet Based Depression Prevention for Adolescents (Promoting AdolescenT Health-PATH)
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Major Depression
  • Depressive Episodes
Intervention  ICMJE 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 (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
Study Arms  ICMJE
  • 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.

    Intervention: Behavioral: CATCH-IT
  • 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.

Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2016)
1142
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2013)
800
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01893749
Other Study ID Numbers  ICMJE 2011-0505
1R01MH090035-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Benjamin Van Voorhees, MD, MPH, University of Illinois at Chicago
Study Sponsor  ICMJE Benjamin Van Voorhees, MD, MPH
Collaborators  ICMJE
  • Wellesley College
  • Northwestern University
  • Harvard Vanguard Medical Associates
  • Access Healthcare Systems
  • NorthShore University HealthSystem
  • Infant Welfare Society
  • Advocate Health Care
  • Franciscan St. Margaret Health - Franciscan Alliance
Investigators  ICMJE
Principal Investigator: Benjamin Van Voorhees, MD, MPH UIC
Principal Investigator: Tracy Gladstone, PHD Wellesley Center for Women
PRS Account University of Illinois at Chicago
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP