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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01267773
Other study ID # MH086606
Secondary ID
Status Recruiting
Phase Phase 1
First received November 16, 2010
Last updated March 20, 2013
Start date August 2010
Est. completion date May 2013

Study information

Verified date March 2013
Source Rhode Island Hospital
Contact Jennifer C Wolff, PhD
Phone 4014443790
Email jwolff2@lifespan.org
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers
Gender Both
Age group 8 Years to 14 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Integrated Treatment


Locations

Country Name City State
United States Rhode Island Hospital Providence Rhode Island

Sponsors (2)

Lead Sponsor Collaborator
Rhode Island Hospital Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Depression Symptoms Change in depression symptoms from baseline to week 24 will be measured using the Children's Depression Inventory baseline to week 24 No
Primary oppositional symptoms change in symptoms of oppositionality from baseline to week 24 will be measured using the Disruptive Behavior Disorders Scale baseline to week 24 No
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