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Completed

NCT Number: NCT00510120

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

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.

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Key information

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Child Study Center

Blacksburg, Virginia, 24060, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parent Management Training (PMT)

Behavioral

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 names: PMT

Collaborative problem solving (CPS)

Behavioral

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 names: CPS

Waitlist Control

Behavioral

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

Primary outcomes

  1. 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

  2. Disruptive Behavior Disorders Rating Scale

    Time frame: Measured at Year 1 follow-up visit

Secondary outcomes

  1. Behavior Assessment System for Children

    Time frame: Measured at Year 1 follow-up visit

  2. 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

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Mediators, Moderators, and Treatment Outcomes With ODD Youth

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Aug 1, 2007
Registry last updated
Jun 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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