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Treatment of Conduct Problems and Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Rhode Island Hospital
Sponsor:
Collaborator:
Brown University
Information provided by (Responsible Party):
Jennifer Wolff, Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT01267773
First received: November 16, 2010
Last updated: March 20, 2013
Last verified: March 2013
  Purpose

Having both depression and conduct problems at the same time has been found to be associated with increased risk for the other and increased risk of negative outcomes. This study will develop an family based cognitive behavioral treatment protocol for youths with both conduct problems and depression, that will take be administered over the course of six months. Youth with comorbid conduct problems and depression will be assigned to the experimental condition or treatment as usual in a community care setting. The treatment manual will be revised as needed. Youth will be assessed before and after treatment to examine program potential. The goal of this research is to develop a more comprehensive outpatient treatment for youth with both conduct problems and depression.


Condition Intervention Phase
Depression
Oppositional Defiant Disorder
Conduct Disorder
Behavioral: Integrated Treatment
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Youth Comorbid Conduct Problems and Depression

Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • Depression Symptoms [ Time Frame: baseline to week 24 ] [ Designated as safety issue: No ]
    Change in depression symptoms from baseline to week 24 will be measured using the Children's Depression Inventory

  • oppositional symptoms [ Time Frame: baseline to week 24 ] [ Designated as safety issue: No ]
    change in symptoms of oppositionality from baseline to week 24 will be measured using the Disruptive Behavior Disorders Scale


Estimated Enrollment: 30
Study Start Date: August 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sequential Treatment Behavioral: Integrated Treatment
Experimental: Integrated Treatment Behavioral: Integrated Treatment

  Eligibility

Ages Eligible for Study:   8 Years to 14 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • 8-14 years old
  • Diagnosis of ODD or CD
  • Diagnosis of Depression
  • Speaks English

Exclusion Criteria:

  • Developmental/cognitive delays
  • Substance dependence
  • Psychotic disorder or symptoms
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01267773

Contacts
Contact: Jennifer C Wolff, PhD 4014443790 jwolff2@lifespan.org

Locations
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Jennifer C Wolff, PhD    401-444-3790    jwolff2@lifespan.org   
Sponsors and Collaborators
Rhode Island Hospital
Brown University
Investigators
Principal Investigator: Jennifer C Wolff, PhD Rhode Island Hospital/Brown University
Principal Investigator: Anthony Spirito, PhD Brown University
  More Information

No publications provided

Responsible Party: Jennifer Wolff, Staff Psychologist, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT01267773     History of Changes
Other Study ID Numbers: MH086606
Study First Received: November 16, 2010
Last Updated: March 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
depression
conduct problems

Additional relevant MeSH terms:
Attention Deficit and Disruptive Behavior Disorders
Conduct Disorder
Depression
Depressive Disorder
Disease
Behavioral Symptoms
Mental Disorders
Mental Disorders Diagnosed in Childhood
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014