NCT00510120

Brief Summary

This study will evaluate the effectiveness of two different psychosocial therapies, parent management training and collaborative problem solving, in treating children with oppositional-defiant disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2007

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

June 7, 2013

Status Verified

June 1, 2013

Enrollment Period

5.2 years

First QC Date

July 30, 2007

Last Update Submit

June 6, 2013

Conditions

Keywords

Attention Deficit and Disruptive Behavior DisordersConduct DisorderBehavior Problems in YouthArgumentativenessChildrenTherapyAttention Deficit Disorder

Outcome Measures

Primary Outcomes (2)

  • ODD, conduct disorder (CD), and attention deficit hyperactivity disorder (ADHD) using a Diagnostic Interview Schedule for Children

    Measured at Year 1 follow-up visit

  • Disruptive Behavior Disorders Rating Scale

    Measured at Year 1 follow-up visit

Secondary Outcomes (2)

  • Behavior Assessment System for Children

    Measured at Year 1 follow-up visit

  • Parent Satisfaction Questionnaire: Parental satisfaction with the treatment approach and the strategies they use to discipline their children in terms of both difficulty and usefulness

    Measured at Weeks 4 and 7, immediately post-treatment, and Year 1 follow-up visit

Study Arms (3)

1

EXPERIMENTAL

Participants will receive collaborative problem solving.

Behavioral: Collaborative problem solving (CPS)

2

ACTIVE COMPARATOR

Participants will receive parent management training.

Behavioral: Parent management training (PMT)

3

ACTIVE COMPARATOR

Participants assigned to waitlist control will receive one of the two treatments after a 10-weeks waitlist period.

Behavioral: Waitlist control

Interventions

PMT primarily involves teaching parents strategies to respond consistently and correctly to their child's behavior. Parents assigned to the PMT group will be taught how to respond consistently and appropriately to their child's positive and negative behaviors. Participants will attend a 1-hour treatment session each week for 10 weeks.

Also known as: PMT
2

CPS is a treatment approach that involves both the parent and child by teaching parents to help their child control their emotions and to problem solve as a family. Parents assigned to the CPS group will be taught strategies to help their child identify and regulate emotions and to solve behavior problems together as a family. Participants will attend a 1-hour treatment session each week for 10 weeks.

Also known as: CPS
1

Participants assigned to the waitlist control condition group will wait 10 weeks before beginning treatment one of the two treatment options.

3

Eligibility Criteria

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

You may qualify if:

  • Meets DSM-IV criteria for oppositional-defiant disorder
  • Parent or guardian willing to provide informed consent

You may not qualify if:

  • History or current diagnosis of CD, autism, pervasive developmental disorders (PDD), or any psychotic disorder
  • An estimated Full Scale IQ below 80
  • Current suicidal or homicidal ideation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child Study Center

Blacksburg, Virginia, 24060, United States

Location

MeSH Terms

Conditions

Oppositional Defiant DisorderAttention Deficit and Disruptive Behavior DisordersConduct DisorderAttention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Officials

  • Thomas H. Ollendick, PhD

    Department of Psychology, Virginia Tech

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University Distinguished Professor

Study Record Dates

First Submitted

July 30, 2007

First Posted

August 1, 2007

Study Start

June 1, 2007

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

June 7, 2013

Record last verified: 2013-06

Locations