NCT01571011

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 4, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

August 4, 2015

Status Verified

July 1, 2015

Enrollment Period

2.1 years

First QC Date

March 20, 2012

Last Update Submit

July 31, 2015

Conditions

Keywords

AdolescentRandomized TrialInternetDepressive DisorderPrimary CarePrevention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Cost effective outcome measures

    6 months

  • Vulnerability

    6 months

  • Protective factors

    6 months

Study Arms (2)

CURB Intervention

EXPERIMENTAL

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

CURB Intervention (Wait List)

EXPERIMENTAL

Same as the CURB Intervention arm, however, individuals assigned to this arm wait 3 months before receiving the intervention.

Behavioral: CURB

Interventions

CURBBEHAVIORAL

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.

CURB InterventionCURB Intervention (Wait List)

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Adolescents:
  • Male and female African American and Latino/a youth ages 13 -17 years old.

You may not qualify if:

  • 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.
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mile Square Health Centers

Chicago, Illinois, 60612, United States

Location

Related Links

MeSH Terms

Conditions

Depressive Disorder, MajorDepressive Disorder

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Study Officials

  • Benjamin Van Voorhees, MD, MPH

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR
  • Monika Marko, MSS

    UIS

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Pediatrics; Chief, Section of General Pediatrics and Adolescent Medicine; Director, TIKES Center Department of Pediatrics

Study Record Dates

First Submitted

March 20, 2012

First Posted

April 4, 2012

Study Start

March 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

August 4, 2015

Record last verified: 2015-07

Locations