CClinicalTrials.gg
Status unknownNCT00189189Updated Oct 2, 2007

Prevention of Oppositional Defiant and Conduct Disorders in Preschool Children

An interventional study of parent management training in Oppositional Defiant Disorder and Conduct Disorder, sponsored by UMC Utrecht. Status unknown at 1 site in Netherlands. Open to participants aged 4 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-10-02.

Sponsored by UMC Utrecht · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jul 2005), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Non-randomized
Ages
4 Years to 5 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Oppositional Defiant Disorder
  • Conduct Disorder

Keywords

  • prevention
  • oppositional defiant disorder
  • conduct disorder
03

In context

Conduct Disorder

95 studies on the registry are indexed under Conduct Disorder; 13 are open to participants now.

This study's planned enrollment of 160 is above the median of 119 across 74 interventional studies indexed under Conduct Disorder.

Browse Conduct Disorder studies →

Lead sponsor

UMC Utrecht is the lead sponsor of 350 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Mastery of the Dutch language is sufficient among the parents to participate in the parent management training
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
160 participants (estimated)

Interventions

  • Behavioralparent management training
06

What researchers measure

Primary outcomes

  1. Composite score consisting of DPICS (behavioral observation) and parent questionnaires (CBCL, Eyberg)

  2. Teacher questionnaire (TRF)

Secondary outcomes

  1. Cost-effectiveness

07

Study locations

1 of 1 sites recruiting
  • University Medical Centre Utrecht
    Utrecht, 3508 GA, Netherlands
    • Walter Matthys, M.D., Ph.D. · Contact · W.Matthys@umcutrecht.nl · 31-302507045
    • Herman van Engeland, M.D., Ph.D. · Contact · H.VanEngeland@umcutrecht.nl · 31-302506362
    • Walter Matthys, M.D., Ph.D. · Principal investigator
    • Maartje Raaijmakers, M.Sc. · Sub investigator
    • Jocelyne Posthumus, M.Sc. · Sub investigator
    Recruiting
08

References and documents

Publications

  • Webster-Stratton C, Hammond M. Treating children with early-onset conduct problems: a comparison of child and parent training interventions. J Consult Clin Psychol. 1997 Feb;65(1):93-109. doi: 10.1037//0022-006x.65.1.93. PubMed 9103739 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00189189
Lead sponsor
UMC Utrecht
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
First posted
Sep 16, 2005
Start date
Jul 2003
Completion
Nov 2008 (estimated)
Last update
Oct 2, 2007

Study contacts

Walter Matthys, M.D., Ph.D.
Contact
W.Matthys@umcutrecht.nl
31-302507045
Walter Matthys, M.D., Ph.D.
principal investigator · UMC Utrecht
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2005. You cannot join it, but the record below documents what was studied.

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