Clinical trial NCT01228890: Primary Care Internet-Based Depression Prevention for Adolescents (CATCH-IT)
Official title: Primary Care Internet-Based Depression Prevention for Adolescents (CATCH-IT)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Depression
Anxiety
Externalizing Symptoms
Substance Abuse
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Harvard Vanguard Medical Associates
First posted: 2010-10-27
Enrollment: 0
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
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.
timeFrame: 49-60 months from beginning of trial
Secondary outcomes:
measure: 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.
timeFrame: 49-60 months from beginning of the trial
measure: 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).
timeFrame: 49-60 months from beginning of trial
measure: To determine for whom (moderators) and how (mediators) the CATCH-IT 2-R program works in this population.
timeFrame: 49-60 months from beginning of trial
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Chicago
country: United States
facility: Access Community Health Network
state: Illinois
city: Evanston
country: United States
facility: Northshore University Health Systems
state: Illinois
city: Boston
country: United States
facility: Harvard Vanguard Medical Associates
state: Massachusetts
Study officials:
affiliation: University of Chicago
name: Benjamin Van Voorhees, MD
role: PRINCIPAL_INVESTIGATOR
References: