NCT01267773

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1 depression

Timeline
Completed

Started Aug 2010

Typical duration for phase_1 depression

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 29, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

March 21, 2013

Status Verified

March 1, 2013

Enrollment Period

2.8 years

First QC Date

November 16, 2010

Last Update Submit

March 20, 2013

Conditions

Keywords

depressionconduct problems

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Sequential Treatment

ACTIVE COMPARATOR
Behavioral: Integrated Treatment

Integrated Treatment

EXPERIMENTAL
Behavioral: Integrated Treatment

Interventions

Integrated TreatmentSequential Treatment

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Age GroupsChild (0-17)

You may qualify if:

  • years old
  • Diagnosis of ODD or CD
  • Diagnosis of Depression
  • Speaks English

You may not qualify if:

  • Developmental/cognitive delays
  • Substance dependence
  • Psychotic disorder or symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Conditions

DepressionOppositional Defiant DisorderConduct Disorder

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Jennifer C Wolff, PhD

    Rhode Island Hospital/Brown University

    PRINCIPAL INVESTIGATOR
  • Anthony Spirito, PhD

    Brown University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer C Wolff, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Psychologist

Study Record Dates

First Submitted

November 16, 2010

First Posted

December 29, 2010

Study Start

August 1, 2010

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

March 21, 2013

Record last verified: 2013-03

Locations