- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00510120
Comparison of Two Psychosocial Therapies for Treating Children With Oppositional-Defiant Disorder
Mediators, Moderators, and Treatment Outcomes With ODD Youth
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Virginia
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Blacksburg, Virginia, United States, 24060
- Child Study Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Participants will receive 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.
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:
|
Active Comparator: 2
Participants will receive parent management training.
|
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:
|
Active Comparator: 3
Participants assigned to waitlist control will receive one of the two treatments after a 10-weeks waitlist period.
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Participants assigned to the waitlist control condition group will wait 10 weeks before beginning treatment one of the two treatment options.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Measured at Year 1 follow-up visit
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Disruptive Behavior Disorders Rating Scale
Time Frame: Measured at Year 1 follow-up visit
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Measured at Year 1 follow-up visit
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Behavior Assessment System for Children
Time Frame: Measured at Year 1 follow-up visit
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Measured at Year 1 follow-up visit
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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
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Measured at Weeks 4 and 7, immediately post-treatment, and Year 1 follow-up visit
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Thomas H. Ollendick, PhD, Department of Psychology, Virginia Tech
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH076141 (U.S. NIH Grant/Contract)
- DDTR B3-PDC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Oppositional-Defiant Disorder
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University of Puerto RicoNational Institute on Minority Health and Health Disparities (NIMHD); Substance... and other collaboratorsRecruitingOppositional Defiant Disorder | Oppositional Defiant Disorder in ChildrenPuerto Rico
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Yeshiva UniversityThe FAR FundCompletedOppositional Defiant Disorder | Oppositional Defiant Disorder in ChildrenUnited States
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Istanbul Bilgi UniversityCenter for Regulation Focused PsychotherapyRecruitingChildhood Externalizing Disorder | Childhood Oppositional Defiant Disorder | Childhood Conduct DisorderTurkey
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University Hospital, MontpellierCompletedOppositional Defiant Disorder With Familial SettingFrance
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Oregon Research Behavioral Intervention Strategies...RecruitingConduct Disorder | Oppositional Defiant DisorderUnited States
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University Hospital, MontpellierCompletedOppositional Defiant DisorderFrance
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University of IcelandStockholm UniversityRecruitingOppositional Defiant DisorderIceland
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Oregon Research InstituteUniversity of LouisvilleCompletedOppositional Defiant Disorder
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University of WashingtonCompletedOppositional Defiant DisorderUnited States
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University of California, San FranciscoNational Institute of Mental Health (NIMH)CompletedADHD | Oppositional Defiant DisorderUnited States
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