- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01267773
Treatment of Conduct Problems and Depression
March 20, 2013 updated by: Jennifer Wolff, Rhode Island Hospital
Treatment of Youth Comorbid Conduct Problems and Depression
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- Recruiting
- Rhode Island Hospital
-
Contact:
- Jennifer C Wolff, PhD
- Phone Number: 401-444-3790
- Email: jwolff2@lifespan.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 14 years (Child)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Integrated Treatment
|
|
|
Active Comparator: Sequential Treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression Symptoms
Time Frame: baseline to week 24
|
Change in depression symptoms from baseline to week 24 will be measured using the Children's Depression Inventory
|
baseline to week 24
|
|
oppositional symptoms
Time Frame: baseline to week 24
|
change in symptoms of oppositionality from baseline to week 24 will be measured using the Disruptive Behavior Disorders Scale
|
baseline to week 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jennifer C Wolff, PhD, Rhode Island Hospital/Brown University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Anticipated)
May 1, 2013
Study Completion (Anticipated)
May 1, 2013
Study Registration Dates
First Submitted
November 16, 2010
First Submitted That Met QC Criteria
December 28, 2010
First Posted (Estimate)
December 29, 2010
Study Record Updates
Last Update Posted (Estimate)
March 21, 2013
Last Update Submitted That Met QC Criteria
March 20, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MH086606
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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