Trial record 2 of 15 for:    Open Studies | "Conduct Disorder"

Prevention of Oppositional Defiant and Conduct Disorders in Preschool Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2005 by UMC Utrecht.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00189189
First received: September 13, 2005
Last updated: October 1, 2007
Last verified: July 2005
  Purpose

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.


Condition Intervention
Oppositional Defiant Disorder
Conduct Disorder
Behavioral: parent management training

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Parent Management Training to Prevent Oppositional Defiant and Conduct Disorders in Preschool Children

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Composite score consisting of DPICS (behavioral observation) and parent questionnaires (CBCL, Eyberg)
  • Teacher questionnaire (TRF)

Secondary Outcome Measures:
  • Cost-effectiveness

Estimated Enrollment: 160
Study Start Date: July 2003
Estimated Study Completion Date: November 2008
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.

  Eligibility

Ages Eligible for Study:   4 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189189

Contacts
Contact: Walter Matthys, M.D., Ph.D. 31-302507045 W.Matthys@umcutrecht.nl

Locations
Netherlands
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.         
Sponsors and Collaborators
UMC Utrecht
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Walter Matthys, M.D., Ph.D. UMC Utrecht
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00189189     History of Changes
Other Study ID Numbers: 03-119, ZonMw: 2620.0001
Study First Received: September 13, 2005
Last Updated: October 1, 2007
Health Authority: Netherlands: Independent Ethics Committee

Keywords provided by UMC Utrecht:
prevention
oppositional defiant disorder
conduct disorder

Additional relevant MeSH terms:
Attention Deficit and Disruptive Behavior Disorders
Conduct Disorder
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on July 31, 2014