Viewing Study NCT00189189



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Last Modification Date: 2024-10-26 @ 9:17 AM
Study NCT ID: NCT00189189
Status: UNKNOWN
Last Update Posted: 2007-10-02
First Post: 2005-09-13

Brief Title: Prevention of Oppositional Defiant and Conduct Disorders in Preschool Children
Sponsor: UMC Utrecht
Organization: UMC Utrecht

Study Overview

Official Title: Parent Management Training to Prevent Oppositional Defiant and Conduct Disorders in Preschool Children
Status: UNKNOWN
Status Verified Date: 2005-07
Last Known Status: RECRUITING
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: 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 adolescents When they become adults they are likely to manifest depressive disorders substance abuse or dependence and criminal behavior These disorders are also two of the costly childhood disorders The aim of the study is to assess the preventive effect of parent management training in preschool children at risk for oppositional defiant and conduct disorders because of high aggression scores on a parent questionnaire It is hypothesized that given the relatively restricted costs of the intervention and the substantial costs of burden associated with these children the intervention will be cost saving
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 childs 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 ie 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 eg CBCL Eyberg parent interviews DDI DISC teacher questionnaires eg 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 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
ZonMw 26200001 None None None