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Clinical Trials/NCT00510120
NCT00510120CompletedNot Applicable

Mediators, Moderators, and Treatment Outcomes With ODD Youth

Virginia Polytechnic Institute and State University1 site in 1 country150 target enrollmentStarted: June 1, 2007Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
150
Locations
1
Primary Endpoint
ODD, conduct disorder (CD), and attention deficit hyperactivity disorder (ADHD) using a Diagnostic Interview Schedule for Children

Study Overview

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.

Detailed Description

Oppositional-defiant disorder (ODD) is characterized by a recurrent pattern of developmentally inappropriate levels of negative, defiant, disobedient, and hostile behavior toward authority figures. Behaviors associated with ODD include temper tantrums; persistent stubbornness; resistance to directions; unwillingness to compromise, give in, or negotiate; deliberate or persistent testing of limits; and verbal and minor physical aggression. The usual treatment approach for children with ODD is parent management training (PMT). PMT primarily involves teaching parents strategies to respond consistently and correctly to their child's behavior. However, PMT does not always lead to longstanding results and there is a need for alternative treatments. Collaborative problem-solving (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. This study will compare the effectiveness of CPS and PMT in treating children with ODD.

Participants in this open-label study will include children with ODD and their parents. Participants will be randomly assigned to one of three groups: CPS, PMT, or waitlist control. 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. Parents assigned to the PMT group will be taught how to respond consistently and appropriately to their child's positive and negative behaviors. Participants assigned to the waitlist control condition group will wait 10 weeks before treatment begins. Participants will attend a 1-hour treatment session each week for 10 weeks. In order to determine whether treatment is effective, participants will be asked to complete a variety of questionnaires, talk with their child about solving problems, and complete a structure diagnostic interview prior to the beginning of treatment, following treatment, and at a 1-year follow-up session. Parents will be asked to submit their child's school grades and school attendance records. If granted permission by the parents, the child's teacher will complete a questionnaire regarding the child's behavior in school for the year prior to participating in the study and up to 1 year after treatment. The information collected will help to determine how treatment affects each child's progress.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
8 Years to 14 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •for Children:
  • •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

Arms & Interventions

1

Experimental

Participants will receive collaborative problem solving.

Intervention: Collaborative problem solving (CPS) (Behavioral)

2

Active Comparator

Participants will receive parent management training.

Intervention: Parent management training (PMT) (Behavioral)

3

Active Comparator

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

Intervention: Waitlist control (Behavioral)

Outcomes

Primary Outcomes

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

Time Frame: Measured at Year 1 follow-up visit

Disruptive Behavior Disorders Rating Scale

Time Frame: Measured at Year 1 follow-up visit

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Thomas H. Ollendick

University Distinguished Professor

Virginia Polytechnic Institute and State University

Study Sites (1)

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