Chicago Urban Resiliency Building (CURB) (CURB)

Chicago Urban Resiliency Building (CURB): Phase 3 Clinical Trial in Primary Care to Engage Adolescents With a Web-based Depression Prevention Intervention

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.

Study Overview

• Status: Completed
• Conditions: Major Depression
• Intervention / Treatment: Behavioral: CURB

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).

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Mile Square Health Centers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CURB Intervention; The intervention is made up of 14 internet modules based on behavioral activation, cognitive behavioral therapy, and interpersonal psychotherapy as well as motivational interviews in the primary care setting (to enhance behavior change). It is suggested that an adolescent navigates through 2 modules a week. The motivational interviews with the physicians occur directly before and after the adolescent is exposed to the website (at baseline and 3 months) in the providers office. The parents of the enrolled adolescents are also invited to navigate through their own, 3 module, parent internet program.	Behavioral: CURB; The intervention is made up of 14 internet modules based on behavioral activation, cognitive behavioral therapy, and interpersonal psychotherapy as well as motivational interviews in the primary care setting (to enhance behavior change). It is suggested that an adolescent navigates through 2 modules a week. The motivational interviews with the physicians occur directly before and after the adolescent is exposed to the website (at baseline and 3 months) in the providers office. The parents of the enrolled adolescents are also invited to navigate through their own, 3 module, parent internet program.
Experimental: CURB Intervention (Wait List); Same as the CURB Intervention arm, however, individuals assigned to this arm wait 3 months before receiving the intervention.	Behavioral: CURB; The intervention is made up of 14 internet modules based on behavioral activation, cognitive behavioral therapy, and interpersonal psychotherapy as well as motivational interviews in the primary care setting (to enhance behavior change). It is suggested that an adolescent navigates through 2 modules a week. The motivational interviews with the physicians occur directly before and after the adolescent is exposed to the website (at baseline and 3 months) in the providers office. The parents of the enrolled adolescents are also invited to navigate through their own, 3 module, parent internet program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Center for Epidemiological Studies of Depression (CES-D) Scale	Change in CESD from baseline Change in CESD scale between and within groups across the 6 months and for each assessment point	0, 3, 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Cost effective outcome measures	6 months
Vulnerability	6 months
Protective factors	6 months

Collaborators and Investigators

• Sponsor: Benjamin Van Voorhees, MD, MPH
• Investigators: Principal Investigator: Benjamin Van Voorhees, MD, MPH, University of Illinois at Chicago; Study Director: Monika Marko, MSS, UIS

Publications and helpful links

Helpful Links

• Sponsor

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: March 20, 2012
• First Submitted That Met QC Criteria: April 3, 2012
• First Posted (Estimate): April 4, 2012

Study Record Updates

• Last Update Posted (Estimate): August 4, 2015
• Last Update Submitted That Met QC Criteria: July 31, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Adolescent; Primary Care; Depressive Disorder; Prevention; Internet; Randomized Trial
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: RWJF 68177