Treatment of Conduct Problems and Depression
This study is currently recruiting participants.
Verified March 2013 by Rhode Island Hospital
Sponsor:
Rhode Island Hospital
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
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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 |
Resource links provided by NLM:
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
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:
|
Depression Depressive Disorder Attention Deficit and Disruptive Behavior Disorders Conduct Disorder |
Behavioral Symptoms Mood Disorders Mental Disorders Mental Disorders Diagnosed in Childhood |
ClinicalTrials.gov processed this record on May 19, 2013