Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510120
Status:
COMPLETED
Last Update Posted:
2013-06-07
First Post:
2007-07-30
Brief Title:
Comparison of Two Psychosocial Therapies for Treating Children With Oppositional-Defiant Disorder
Sponsor:
Virginia Polytechnic Institute and State University
Organization:
Virginia Polytechnic Institute and State University
Study Overview
Official Title:
Mediators Moderators and Treatment Outcomes With ODD Youth
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 childs 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 childs 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 childs school grades and school attendance records If granted permission by the parents the childs teacher will complete a questionnaire regarding the childs 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 childs progress
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 childs 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 childs school grades and school attendance records If granted permission by the parents the childs teacher will complete a questionnaire regarding the childs 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 childs progress
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DDTR B3-PDC | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH076141 |
| R01MH076141 | NIH | None | None |