Chicago Urban Resiliency Building (CURB): Trial in Primary Care to Engage Adolescents With a Web-based Depression Prevention Intervention - Full Text View

Purpose

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.

Condition	Intervention
Major Depression	Behavioral: CURB

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Chicago Urban Resiliency Building (CURB): Phase 3 Clinical Trial in Primary Care to Engage Adolescents With a Web-based Depression Prevention Intervention

Resource links provided by NLM:

MedlinePlus related topics: Depression

U.S. FDA Resources

Further study details as provided by University of Illinois:

Primary Outcome Measures:

Change in depression related outcomes [ Time Frame: 0, 3, 6 months ] [ Designated as safety issue: No ]
Disorders

Secondary Outcome Measures:

Cost effective outcome measures [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Vulnerability [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Protective factors [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	254
Study Start Date:	March 2012
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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: Wait-List CURB Intervention (3 month delay) 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.

Arms

Assigned Interventions

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: Wait-List CURB Intervention (3 month delay)

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.

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

Ages Eligible for Study:	13 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01571011

Contacts

Contact: Marya Corden, MPH, CPH	312-996-6713	mcorden@uic.edu
Contact: Monika Marko-Holguin, MA	312-996-0407	mmarko@uic.edu

Locations

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

Sponsors and Collaborators

Benjamin Van Voorhees, MD, MPH

Investigators

Principal Investigator:	Benjamin Van Voorhees, MD, MPH	University of Illinois
Study Director:	Marya E Corden, MPH, CPH	University of Illinois

More Information

Additional Information:

Sponsor

Recruitment Clinics This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Benjamin Van Voorhees, MD, MPH, Associate Professor of Pediatrics; Chief, Section of General Pediatrics and Adolescent Medicine; Director, TIKES Center Department of Pediatrics, University of Illinois
ClinicalTrials.gov Identifier:	NCT01571011 History of Changes
Other Study ID Numbers:	RWJF 68177
Study First Received:	March 20, 2012
Last Updated:	April 3, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Illinois:

Adolescent
Randomized Trial
Internet

Depressive Disorder
Primary Care
Prevention

Additional relevant MeSH terms:

Depression
Depressive Disorder
Depressive Disorder, Major

Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013