Clinical trial NCT00510120: 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
Overall status: COMPLETED
Phase: NA
Conditions: Oppositional-Defiant Disorder
Keywords: Attention Deficit and Disruptive Behavior Disorders
Conduct Disorder
Behavior Problems in Youth
Argumentativeness
Children
Therapy
Attention Deficit Disorder
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2007-08-01
Enrollment: 150
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: ODD, conduct disorder (CD), and attention deficit hyperactivity disorder (ADHD) using a Diagnostic Interview Schedule for Children
timeFrame: Measured at Year 1 follow-up visit
measure: Disruptive Behavior Disorders Rating Scale
timeFrame: Measured at Year 1 follow-up visit
Secondary outcomes:
measure: Behavior Assessment System for Children
timeFrame: Measured at Year 1 follow-up visit
measure: 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
timeFrame: Measured at Weeks 4 and 7, immediately post-treatment, and Year 1 follow-up visit
Other outcomes:
Locations:
city: Blacksburg
country: United States
facility: Child Study Center
state: Virginia
Study officials:
affiliation: Department of Psychology, Virginia Tech
name: Thomas H. Ollendick, PhD
role: PRINCIPAL_INVESTIGATOR
References: