Prevention of Oppositional Defiant and Conduct Disorders in Preschool Children
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|ClinicalTrials.gov Identifier: NCT00189189|
Recruitment Status : Unknown
Verified July 2005 by UMC Utrecht.
Recruitment status was: Recruiting
First Posted : September 16, 2005
Last Update Posted : October 2, 2007
|Condition or disease||Intervention/treatment||Phase|
|Oppositional Defiant Disorder Conduct Disorder||Behavioral: parent management training||Not Applicable|
Oppositional defiant and conduct disorders are the most frequent bases for referral of children and adolescents. These disorders are difficult to treat among school-aged children and, even more, among adolescents. When they become adults they are likely to manifest depressive disorders, substance abuse or dependence, criminal behavior and social maladjustment. As parents they are likely to pass along antisocial behavior to their offspring. These disorders are also two of the costly childhood disorders. The children and their parents frequently use social and mental health services. The prevention of these disorders in preschool children at risk thus is clearly relevant.
The origins of oppositional defiant and conduct disorders lie in temperamental vulnerabilities of the preschool child in interaction with non-optimal characteristics of the child's environment. Specifically, ineffective parenting plays a key role in the development of the disorders: a predisposing temperament evokes the kinds of coercive, harsh, inconsistent and negative parenting behaviors that transform a difficult temperament into antisocial behavior. These inadequate parenting behaviors are targeted in parent management training.
In the present study, we will assess the preventive effects of the Incredible Years parent program (Webster-Stratton) in preschool children at risk of oppositional defiant and conduct disorders. Besides, we will study the moderating effects of psychophysiological (heart rate, skin conductance) and neuropsychological variables on intervention outcome. We also will study mediation, i.e. whether the positive outcome is caused by favourable changes in the parenting skills. Finally, costs and cost-effectiveness will be studied.
A hundred sixty children aged four and a half years are selected on the basis of high aggression scores on the Child Behavior Checklist. The parents of seventy children participate in a group parent training. Ninety children serve as care as usual controls and are matched on a person to person basis. Assessments are at pretreatment, posttreatment, one year follow-up, and two year follow-up. Outcome measures consist of parent questionnaires (e.g. CBCL, Eyberg), parent interviews (DDI, DISC), teacher questionnaires (e.g. TRF), and observations of parent-child interactions at home (DPICS). Parenting skills are assessed using observations of parent-child interactions (DPICS). Detailed information on the costs of the intervention and on the costs generated by the conduct problems (medical consumption, education) is monitored.
If the Incredible Years program is shown to be effective, we will have a program in the Netherlands to prevent oppositional defiant and conduct disorders from developing in high-risk preschool children. Four to five year old children who according to their parents or teachers are hard to manage and show high aggression scores on the CBCL or TRF can be monitored. If the scores remain high, the parents are invited to participate in the Incredible Years parent program.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Parent Management Training to Prevent Oppositional Defiant and Conduct Disorders in Preschool Children|
|Study Start Date :||July 2003|
|Estimated Study Completion Date :||November 2008|
- Composite score consisting of DPICS (behavioral observation) and parent questionnaires (CBCL, Eyberg)
- Teacher questionnaire (TRF)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00189189
|Contact: Walter Matthys, M.D., Ph.D.||31-302507045||W.Matthys@umcutrecht.nl|
|University Medical Centre Utrecht||Recruiting|
|Utrecht, Netherlands, 3508 GA|
|Contact: Walter Matthys, M.D., Ph.D. 31-302507045 W.Matthys@umcutrecht.nl|
|Contact: Herman van Engeland, M.D., Ph.D. 31-302506362 H.VanEngeland@umcutrecht.nl|
|Principal Investigator: Walter Matthys, M.D., Ph.D.|
|Sub-Investigator: Maartje Raaijmakers, M.Sc.|
|Sub-Investigator: Jocelyne Posthumus, M.Sc.|
|Principal Investigator:||Walter Matthys, M.D., Ph.D.||UMC Utrecht|