Clinical trial NCT01571011: Chicago Urban Resiliency Building (CURB)
Official title: Chicago Urban Resiliency Building (CURB): Phase 3 Clinical Trial in Primary Care to Engage Adolescents With a Web-based Depression Prevention Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression
Keywords: Adolescent
Randomized Trial
Internet
Depressive Disorder
Primary Care
Prevention
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2012-04-04
Enrollment: 10
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to determine whether a culturally tailored, low-cost, primary care/internet based depression prevention intervention (CURB) is superior to wait-list control for African American and Hispanic youth in terms of depression-related outcomes. It is hypothesized that compared to teens in the wait-list control condition, teens in the CURB program will exhibit lower levels of depressed mood and/or more rapid changes in mood during the follow-up time.

Detailed description: Additional aims and hypotheses are provided here:

Aim 2: To determine whether or not participants in the CURB primary care/Internet based depression prevention intervention will have a significantly lower cumulative incidence of any depressive episode at 3 months compared to adolescents in the usual care wait-list group.

Hypothesis 2: Compared to youth in the wait-list control condition, youth in the CURB program will have a lower incidence of depressive episodes at 6 month follow-up.

Aim 3: To determine whether CURB is sustainable in primary care from the perspective of health care professionals and primary care physicians in urban primary care settings.

Hypothesis 3: We hypothesize that providers will rate the intervention (by component) feasibility, acceptability, willingness to perform intervention and sustainability \> 7 on a 1-10 scale (1, not feasible, 10 very feasible).

Eligibility criteria: Inclusion Criteria:

Adolescents:

* Male and female African American and Latino/a youth ages 13 -17 years old.
* Adolescents with depressed mood (\> 2 weeks duration) will be eligible unless they have already exceeded the diagnostic threshold for major depressive disorder or have a comorbid condition as defined in the exclusion criteria.

Parents:

* Parent of eligible adolescents

Primary Care Physicians (PCPs):

* Physician at one of the four Mile Square Health Centers.

Health Care Professionals:

* Employee at one of the four Mile Square Health Centers.

Exclusion Criteria:

* Adolescents undergoing active treatment for depression \[Active treatment for depression is defined as receiving anti-depressant medication or counseling within one year of remission of symptoms from the most recent episode\]
* Adolescents meeting probable diagnostic criteria for the following: Major depression, Substance and alcohol abuse, Panic attacks, Generalized anxiety disorder, Eating disorders, History of treatment for bi-polar disorder or schizophrenia or who are at elevated risk for suicide (often have suicidal thoughts or recent intent)

Primary outcomes:
measure: The Center for Epidemiological Studies of Depression (CES-D) Scale
timeFrame: 0, 3, 6 months
Secondary outcomes:
measure: Cost effective outcome measures
timeFrame: 6 months
measure: Vulnerability
timeFrame: 6 months
measure: Protective factors
timeFrame: 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Mile Square Health Centers
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Benjamin Van Voorhees, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: UIS
name: Monika Marko, MSS
role: STUDY_DIRECTOR
References: