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NCT00510120 Clinical Trial

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

Oppositional-Defiant Disorder Clinical Trial

Official title:
Mediators, Moderators, and Treatment Outcomes With ODD Youth

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00510120
Other study ID # R01MH076141
Secondary ID R01MH076141DDTR
Status Completed
Phase N/A
First received July 30, 2007
Last updated June 6, 2013
Start date June 2007
Est. completion date August 2012

Study information
Verified date June 2013
Source Virginia Polytechnic Institute and State University
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 14 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Child Study Center Blacksburg Virginia

Sponsors (2)
Lead Sponsor Collaborator
Virginia Polytechnic Institute and State University National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary ODD, conduct disorder (CD), and attention deficit hyperactivity disorder (ADHD) using a Diagnostic Interview Schedule for Children Measured at Year 1 follow-up visit No
Primary Disruptive Behavior Disorders Rating Scale Measured at Year 1 follow-up visit No
Secondary Behavior Assessment System for Children Measured at Year 1 follow-up visit No
Secondary 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 No

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