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Comparison of Two Psychosocial Therapies for Treating Children With Oppositional-Defiant Disorder

Primary Purpose

Oppositional-Defiant Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parent management training (PMT)
Collaborative problem solving (CPS)
Waitlist control
Sponsored by
Virginia Polytechnic Institute and State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oppositional-Defiant Disorder focused on measuring Attention Deficit and Disruptive Behavior Disorders, Conduct Disorder, Behavior Problems in Youth, Argumentativeness, Children, Therapy, Attention Deficit Disorder

Eligibility Criteria

8 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Child Study Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

Participants will receive collaborative problem solving.

Participants will receive parent management training.

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

Outcomes

Primary Outcome Measures

ODD, conduct disorder (CD), and attention deficit hyperactivity disorder (ADHD) using a Diagnostic Interview Schedule for Children
Disruptive Behavior Disorders Rating Scale

Secondary Outcome Measures

Behavior Assessment System for Children
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

Full Information

First Posted
July 30, 2007
Last Updated
June 6, 2013
Sponsor
Virginia Polytechnic Institute and State University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00510120
Brief Title
Comparison of Two Psychosocial Therapies for Treating Children With Oppositional-Defiant Disorder
Official Title
Mediators, Moderators, and Treatment Outcomes With ODD Youth
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Virginia Polytechnic Institute and State University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oppositional-Defiant Disorder
Keywords
Attention Deficit and Disruptive Behavior Disorders, Conduct Disorder, Behavior Problems in Youth, Argumentativeness, Children, Therapy, Attention Deficit Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive collaborative problem solving.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive parent management training.
Arm Title
3
Arm Type
Active Comparator
Arm Description
Participants assigned to waitlist control will receive one of the two treatments after a 10-weeks waitlist period.
Intervention Type
Behavioral
Intervention Name(s)
Parent management training (PMT)
Other Intervention Name(s)
PMT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Collaborative problem solving (CPS)
Other Intervention Name(s)
CPS
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Waitlist control
Intervention Description
Participants assigned to the waitlist control condition group will wait 10 weeks before beginning treatment one of the two treatment options.
Primary Outcome Measure Information:
Title
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
Title
Disruptive Behavior Disorders Rating Scale
Time Frame
Measured at Year 1 follow-up visit
Secondary Outcome Measure Information:
Title
Behavior Assessment System for Children
Time Frame
Measured at Year 1 follow-up visit
Title
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
Time Frame
Measured at Weeks 4 and 7, immediately post-treatment, and Year 1 follow-up visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas H. Ollendick, PhD
Organizational Affiliation
Department of Psychology, Virginia Tech
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child Study Center
City
Blacksburg
State/Province
Virginia
ZIP/Postal Code
24060
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Comparison of Two Psychosocial Therapies for Treating Children With Oppositional-Defiant Disorder

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