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

This study has been withdrawn prior to enrollment.
(no one enrolled; PI left institution)
Sponsor:
Collaborator:
Harvard Vanguard Medical Associates
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01228890
First received: October 25, 2010
Last updated: December 13, 2012
Last verified: December 2012

October 25, 2010
December 13, 2012
September 2010
April 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01228890 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Primary Care Internet-Based Depression Prevention for Adolescents (CATCH-IT)
Primary Care Internet-Based Depression Prevention for Adolescents (CATCH-IT)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Depression
  • Anxiety
  • Externalizing Symptoms
  • Substance Abuse
  • Behavioral: CATCH-IT
    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).
  • Behavioral: AMPE
    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.
  • Experimental: CATCH-IT 2-R Arm
    Primary care/Internet based depression prevention intervention (CATCH-IT 2-R) with a family component.
    Intervention: Behavioral: CATCH-IT
  • Active Comparator: Attention Monitoring Psycho-education (AMPE) Arm
    Intervention: Behavioral: AMPE
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
April 2011
April 2011   (final data collection date for primary outcome measure)

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).
Both
13 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01228890
10-464-A
No
University of Chicago
University of Chicago
Harvard Vanguard Medical Associates
Principal Investigator: Benjamin Van Voorhees, MD University of Chicago
University of Chicago
December 2012

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