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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Thomas H. Ollendick, Virginia Polytechnic Institute and State University
ClinicalTrials.gov Identifier:
NCT00510120
First received: July 30, 2007
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Oppositional-Defiant Disorder
Behavioral: Parent management training (PMT)
Behavioral: Collaborative problem solving (CPS)
Behavioral: Waitlist control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mediators, Moderators, and Treatment Outcomes With ODD Youth

Resource links provided by NLM:


Further study details as provided by Virginia Polytechnic Institute and State University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Disruptive Behavior Disorders Rating Scale [ Time Frame: Measured at Year 1 follow-up visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Behavior Assessment System for Children [ Time Frame: Measured at Year 1 follow-up visit ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: June 2007
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive collaborative problem solving.
Behavioral: Collaborative problem solving (CPS)
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.
Other Name: CPS
Active Comparator: 2
Participants will receive parent management training.
Behavioral: Parent management training (PMT)
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.
Other Name: PMT
Active Comparator: 3
Participants assigned to waitlist control will receive one of the two treatments after a 10-weeks waitlist period.
Behavioral: Waitlist control
Participants assigned to the waitlist control condition group will wait 10 weeks before beginning treatment one of the two treatment options.

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.

  Eligibility

Ages Eligible for Study:   8 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510120

Locations
United States, Virginia
Child Study Center
Blacksburg, Virginia, United States, 24060
Sponsors and Collaborators
Virginia Polytechnic Institute and State University
Investigators
Principal Investigator: Thomas H. Ollendick, PhD Department of Psychology, Virginia Tech
  More Information

Additional Information:
No publications provided

Responsible Party: Thomas H. Ollendick, University Distinguished Professor, Virginia Polytechnic Institute and State University
ClinicalTrials.gov Identifier: NCT00510120     History of Changes
Other Study ID Numbers: R01 MH076141, R01MH076141, DDTR B3-PDC
Study First Received: July 30, 2007
Last Updated: June 6, 2013
Health Authority: United States: Federal Government

Keywords provided by Virginia Polytechnic Institute and State University:
Attention Deficit and Disruptive Behavior Disorders
Conduct Disorder
Behavior Problems in Youth
Argumentativeness
Children
Therapy
Attention Deficit Disorder

Additional relevant MeSH terms:
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014