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Primary Care Internet-Based Depression Prevention for Adolescents (CATCH-IT) (CATCH-IT)

Primary Purpose

Depression, Anxiety, Externalizing Symptoms

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CATCH-IT
AMPE
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Youth ages 13 through 17.
  • Youth must be experiencing elevated level of depressive symptoms on the Center for Epidemiologic Studies Depression46 (CES-D) scale (score >/= 16) and have at least two core symptoms of Major Depression on the Patient Health Questionnaire, Adolescents.
  • Youth will be included if they have a past history of depression, anxiety, externalizing symptoms, or substance abuse.

Exclusion Criteria:

  • Current DSM-IV diagnosis (Kiddie Schedule of Affective Disorders) 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 suicidality 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).

Sites / Locations

  • University of Chicago
  • Access Community Health Network
  • Northshore University Health Systems
  • Harvard Vanguard Medical Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CATCH-IT 2-R Arm

Attention Monitoring Psycho-education (AMPE) Arm

Arm Description

Primary care/Internet based depression prevention intervention (CATCH-IT 2-R) with a family component.

Outcomes

Primary Outcome Measures

To determine whether the CATCH-IT 2-R depression prevention intervention prevents or delays major depressive episodes, as well as non-affective disorder episodes, compared to AMPE.

Secondary Outcome Measures

To determine if participants in the CATCH-IT 2-R group exhibit more rapid favorable changes of depressive symptoms/and or vulnerability/protective factors compared with the AMPE group.
To determine if participants in the CATCH-IT 2-R 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).
To determine for whom (moderators) and how (mediators) the CATCH-IT 2-R program works in this population.

Full Information

First Posted
October 25, 2010
Last Updated
December 13, 2012
Sponsor
University of Chicago
Collaborators
Harvard Vanguard Medical Associates
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1. Study Identification

Unique Protocol Identification Number
NCT01228890
Brief Title
Primary Care Internet-Based Depression Prevention for Adolescents (CATCH-IT)
Acronym
CATCH-IT
Official Title
Primary Care Internet-Based Depression Prevention for Adolescents (CATCH-IT)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Withdrawn
Why Stopped
no one enrolled; PI left institution
Study Start Date
September 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Harvard Vanguard Medical Associates

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In this 5-year, two-site randomized clinical trial, we propose to test the efficacy of the CATCH-IT primary care/Internet based depression prevention intervention against Attention Monitoring Psychoeducation (AMPE) in preventing the onset of depressive episodes in an intermediate to high risk group of adolescents aged 13-17. We plan to (a) identify high risk adolescents based on elevated scores on the PHQ-A, a screening measure of depressive symptoms; (b) recruit 400 (200 per site) of these at-risk adolescents to be randomized into either the CATCH-IT or the AMPE group; (c) assess outcomes at 2, 8, 12, 18, and 24 months post intake on measures of depressive symptoms, depressive diagnoses, other mental disorders, and on measures of role impairment in education, quality of life, attainment of educational milestones, and family functioning; and (d) conduct exploratory analyses to examine the effectiveness of this intervention program, moderators of protection, and potential ethnic and cultural differences in intervention response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Externalizing Symptoms, Substance Abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CATCH-IT 2-R Arm
Arm Type
Experimental
Arm Description
Primary care/Internet based depression prevention intervention (CATCH-IT 2-R) with a family component.
Arm Title
Attention Monitoring Psycho-education (AMPE) Arm
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
CATCH-IT
Intervention Description
The CATCH-IT 2-R intervention has a motivational (3 PCP motivational interviews at time 0, 1.5 months and 12 months and 3 coaching phone calls at 2 and 4 weeks and 18 months) and an Internet component (with separate adolescent [14 modules] and parent [5 modules] programs). This revised and expanded intervention will include a comprehensive approach to reducing modifiable risk factors and enhancing resiliency factors associated with increased or decreased risk of depression, respectively, proposed by Spence and Reinecke.148 The revised CATCH-IT "Tracker" will monitor time in study and deploy elements of the intervention based on time since enrollment, including computer and human elements (e.g. calls, doctor visits).
Intervention Type
Behavioral
Intervention Name(s)
AMPE
Intervention Description
The AMPE components are similar to those employed in previous primary care based quality improvement/Chronic Care Model Interventions (patient education [psycho-education described below], provider training [described in Case Finding and Recruitment], active monitoring and referral [case management, discussed under assessments], physician and nurse education and routine contact with PCP [study design rationale]). This Internet site will focus on assisting parents and adolescents in early identification of need for treatment and will also target stigma and negative attitudes toward treatment of mental disorders we have previously identified as barriers to seeking and adhering to treatment.
Primary Outcome Measure Information:
Title
To determine whether the CATCH-IT 2-R depression prevention intervention prevents or delays major depressive episodes, as well as non-affective disorder episodes, compared to AMPE.
Time Frame
49-60 months from beginning of trial
Secondary Outcome Measure Information:
Title
To determine if participants in the CATCH-IT 2-R group exhibit more rapid favorable changes of depressive symptoms/and or vulnerability/protective factors compared with the AMPE group.
Time Frame
49-60 months from beginning of the trial
Title
To determine if participants in the CATCH-IT 2-R 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).
Time Frame
49-60 months from beginning of trial
Title
To determine for whom (moderators) and how (mediators) the CATCH-IT 2-R program works in this population.
Time Frame
49-60 months from beginning of trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Youth ages 13 through 17. Youth must be experiencing elevated level of depressive symptoms on the Center for Epidemiologic Studies Depression46 (CES-D) scale (score >/= 16) and have at least two core symptoms of Major Depression on the Patient Health Questionnaire, Adolescents. Youth will be included if they have a past history of depression, anxiety, externalizing symptoms, or substance abuse. Exclusion Criteria: Current DSM-IV diagnosis (Kiddie Schedule of Affective Disorders) 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 suicidality 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Van Voorhees, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Access Community Health Network
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Northshore University Health Systems
City
Evanston
State/Province
Illinois
Country
United States
Facility Name
Harvard Vanguard Medical Associates
City
Boston
State/Province
Massachusetts
Country
United States

12. IPD Sharing Statement

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Primary Care Internet-Based Depression Prevention for Adolescents (CATCH-IT)

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