Treatment of Conduct Problems and Depression | NCT01267773

Studies
Treatment of Conduct Problems and Depression

NCT01267773

Sponsor

Rhode Island Hospital

Status

Unknown status

Last Update Posted

Mar 21, 2013Estimated

Enrollment

30Estimated

Phase

Phase 1

Conditions

Depression
Oppositional Defiant Disorder
Conduct Disorder

Interventions

Integrated Treatment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

May 2013Estimated

Completion Date

May 2013Estimated

First Submitted Date

Nov 16, 2010

First Submission Date that Met QC Criteria

Dec 28, 2010

First Posted Date

Dec 29, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2013

Last Update Posted Date

Mar 21, 2013Estimated

Name	Class
Brown University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sequential Treatment	Active Comparator		Behavioral: Integrated Treatment
Integrated Treatment	Experimental		Behavioral: Integrated Treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Integrated Treatment	Behavioral		Integrated Treatment Sequential Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Depression Symptoms	Change in depression symptoms from baseline to week 24 will be measured using the Children's Depression Inventory	baseline to week 24
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jennifer C Wolff, PhD	Contact	4014443790		jwolff2@lifespan.org

Overall Officials

Name	Affiliation	Role
Jennifer C Wolff, PhD	Rhode Island Hospital/Brown University	Principal Investigator
Anthony Spirito, PhD	Brown University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rhode Island Hospital	Recruiting	Providence	Rhode Island	02903	United States

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D000096865	Oppositional Defiant Disorder
D019955	Conduct Disorder

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided