Oppositional-Defiant DisorderNCT00510120
Comparison of Two Psychosocial Therapies for Treating Children With Oppositional-Defiant Disorder
A study testing Parent management training (PMT) and Collaborative problem solving (CPS) in people with Oppositional-Defiant Disorder, run by Virginia Polytechnic Institute and State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Oppositional-Defiant Disorder
- What is being tested?
- Parent management training (PMT) and Collaborative problem solving (CPS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Meets DSM-IV criteria for oppositional-defiant disorder
- Parent or guardian willing to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mediators, Moderators, and Treatment Outcomes With ODD Youth
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.
Read the 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.
- Conditions
- Oppositional-Defiant Disorder
- Being tested
- Parent management training (PMT), Collaborative problem solving (CPS), Waitlist control
- Keywords
- Attention Deficit and Disruptive Behavior Disorders, Conduct Disorder, Behavior Problems in Youth, Argumentativeness, Children, Therapy, Attention Deficit Disorder
- Medical subject headings
- Oppositional Defiant Disorder, Attention Deficit and Disruptive Behavior Disorders, Conduct Disorder, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent management training (PMT)Behavioural
Also called 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)Behavioural
Also called 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 controlBehavioural
Participants assigned to the waitlist control condition group will wait 10 weeks before beginning treatment one of the two treatment options.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive collaborative problem solving. Receives: Behavioral: Collaborative problem solving (CPS) |
| 2 | Active comparator | Participants will receive parent management training. Receives: Behavioral: Parent management training (PMT) |
| 3 | Active comparator | Participants assigned to waitlist control will receive one of the two treatments after a 10-weeks waitlist period. Receives: Behavioral: Waitlist control |
What is being measured
The primary outcome is the main question the study is designed to answer.
ODD, conduct disorder (CD), and attention deficit hyperactivity disorder (ADHD) using a Diagnostic Interview Schedule for Children
Measured: Measured at Year 1 follow-up visit
Disruptive Behavior Disorders Rating Scale
Measured: Measured at Year 1 follow-up visit
Secondary outcomes (2)
Behavior Assessment System for Children
Measured: Measured at Year 1 follow-up visit
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: Measured at Weeks 4 and 7, immediately post-treatment, and Year 1 follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2007 (estimated)
- Study startJun 2007
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oppositional-Defiant DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Thomas H. Ollendick, Virginia Polytechnic Institute and State University
- Investigators
- Thomas H. Ollendick, PhD, Principal investigator, Department of Psychology, Virginia Tech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510120
- Sponsor's protocol ID
- R01MH076141
- Other IDs
- R01MH076141, DDTR B3-PDC
- Status last verified
- Jun 2013
- First submitted
- 30 Jul 2007
- Last updated
- 7 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediators, Moderators, and Treatment Outcomes With ODD Youth
- ClinicalTrials.gov ID
- NCT00510120
- Acronym / sponsor ID
- R01MH076141
- Conditions
- Oppositional-Defiant Disorder
- Keywords
- Attention Deficit and Disruptive Behavior Disorders, Conduct Disorder, Behavior Problems in Youth, Argumentativeness, Children, Therapy, Attention Deficit Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2007
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 1 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Collaborative problem solving (CPS)Participants will receive collaborative problem solving. |
| 2 | Active comparator | Behavioral: Parent management training (PMT)Participants will receive parent management training. |
| 3 | Active comparator | Behavioral: Waitlist controlParticipants assigned to waitlist control will receive one of the two treatments after a 10-weeks waitlist period. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Meets DSM-IV criteria for oppositional-defiant disorder
- Parent or guardian willing to provide informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent management training (PMT)Also: PMTPMT 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. | Behavioural | 2 |
| Collaborative problem solving (CPS)Also: CPSCPS 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. | Behavioural | 1 |
| Waitlist controlParticipants assigned to the waitlist control condition group will wait 10 weeks before beginning treatment one of the two treatment options. | Behavioural | 3 |
Primary outcome
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
Disruptive Behavior Disorders Rating Scale
Time frame: Measured at Year 1 follow-up visit
2 secondary outcomes
Behavior Assessment System for Children
Time frame: Measured at Year 1 follow-up visit
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2013.
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Testing a Measurement Feedback App to Improve Data Quality, Supervision & Outcomes in Behavioral Health
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas H. Ollendick, PhD principal investigator
Department of Psychology, Virginia Tech
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent management training (PMT) and Collaborative problem solving (CPS) in people with Oppositional-Defiant Disorder, run by Virginia Polytechnic Institute and State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2013.