Back to resultsTreatment of Conduct Problems and Depression
Primary Purpose
Depression, Oppositional Defiant Disorder, Conduct Disorder
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Integrated Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring depression, conduct problems
Eligibility 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
Sites / Locations
- Rhode Island HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Sequential Treatment
Integrated Treatment
Arm Description
Outcomes
Primary Outcome Measures
Depression Symptoms
Change in depression symptoms from baseline to week 24 will be measured using the Children's Depression Inventory
oppositional symptoms
change in symptoms of oppositionality from baseline to week 24 will be measured using the Disruptive Behavior Disorders Scale
Secondary Outcome Measures
Full Information
NCT ID
NCT01267773
First Posted
November 16, 2010
Last Updated
March 20, 2013
Sponsor
Rhode Island Hospital
Collaborators
Brown University
1. Study Identification
Unique Protocol Identification Number
NCT01267773
Brief Title
Treatment of Conduct Problems and Depression
Official Title
Treatment of Youth Comorbid Conduct Problems and Depression
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
May 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rhode Island Hospital
Collaborators
Brown University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Oppositional Defiant Disorder, Conduct Disorder
Keywords
depression, conduct problems
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sequential Treatment
Arm Type
Active Comparator
Arm Title
Integrated Treatment
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Integrated Treatment
Primary Outcome Measure Information:
Title
Depression Symptoms
Description
Change in depression symptoms from baseline to week 24 will be measured using the Children's Depression Inventory
Time Frame
baseline to week 24
Title
oppositional symptoms
Description
change in symptoms of oppositionality from baseline to week 24 will be measured using the Disruptive Behavior Disorders Scale
Time Frame
baseline to week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer C Wolff, PhD
Phone
4014443790
Email
jwolff2@lifespan.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer C Wolff, PhD
Organizational Affiliation
Rhode Island Hospital/Brown University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anthony Spirito, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer C Wolff, PhD
Phone
401-444-3790
Email
jwolff2@lifespan.org
12. IPD Sharing Statement
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Treatment of Conduct Problems and Depression
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