- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00189189
Prevention of Oppositional Defiant and Conduct Disorders in Preschool Children
Parent Management Training to Prevent Oppositional Defiant and Conduct Disorders in Preschool Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Walter Matthys, M.D., Ph.D.
- Phone Number: 31-302507045
- Email: W.Matthys@umcutrecht.nl
Study Locations
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Utrecht, Netherlands, 3508 GA
- Recruiting
- University Medical Centre Utrecht
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Contact:
- Walter Matthys, M.D., Ph.D.
- Phone Number: 31-302507045
- Email: W.Matthys@umcutrecht.nl
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Contact:
- Herman van Engeland, M.D., Ph.D.
- Phone Number: 31-302506362
- Email: H.VanEngeland@umcutrecht.nl
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Principal Investigator:
- Walter Matthys, M.D., Ph.D.
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Sub-Investigator:
- Maartje Raaijmakers, M.Sc.
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Sub-Investigator:
- Jocelyne Posthumus, M.Sc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aggression score on Child Behavior Checklist (CBCL) of at least 80th percentile
- Age of child: between 4 and 5 years old
Exclusion Criteria:
- Mastery of the Dutch language is sufficient among the parents to participate in the parent management training
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Composite score consisting of DPICS (behavioral observation) and parent questionnaires (CBCL, Eyberg)
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Teacher questionnaire (TRF)
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Secondary Outcome Measures
Outcome Measure |
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Cost-effectiveness
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Walter Matthys, M.D., Ph.D., UMC Utrecht
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03-119
- ZonMw: 2620.0001
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