Prevention of Oppositional Defiant and Conduct Disorders in Preschool Children
Primary Purpose
Oppositional Defiant Disorder, Conduct Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
parent management training
Sponsored by
About this trial
This is an interventional prevention trial for Oppositional Defiant Disorder focused on measuring prevention, oppositional defiant disorder, conduct disorder
Eligibility 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
Sites / Locations
- University Medical Centre UtrechtRecruiting
Outcomes
Primary Outcome Measures
Composite score consisting of DPICS (behavioral observation) and parent questionnaires (CBCL, Eyberg)
Teacher questionnaire (TRF)
Secondary Outcome Measures
Cost-effectiveness
Full Information
NCT ID
NCT00189189
First Posted
September 13, 2005
Last Updated
October 1, 2007
Sponsor
UMC Utrecht
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT00189189
Brief Title
Prevention of Oppositional Defiant and Conduct Disorders in Preschool Children
Official Title
Parent Management Training to Prevent Oppositional Defiant and Conduct Disorders in Preschool Children
Study Type
Interventional
2. Study Status
Record Verification Date
July 2005
Overall Recruitment Status
Unknown status
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
UMC Utrecht
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
4. Oversight
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oppositional Defiant Disorder, Conduct Disorder
Keywords
prevention, oppositional defiant disorder, conduct disorder
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
parent management training
Primary Outcome Measure Information:
Title
Composite score consisting of DPICS (behavioral observation) and parent questionnaires (CBCL, Eyberg)
Title
Teacher questionnaire (TRF)
Secondary Outcome Measure Information:
Title
Cost-effectiveness
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Walter Matthys, M.D., Ph.D.
Phone
31-302507045
Email
W.Matthys@umcutrecht.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Matthys, M.D., Ph.D.
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Centre Utrecht
City
Utrecht
ZIP/Postal Code
3508 GA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Walter Matthys, M.D., Ph.D.
Phone
31-302507045
Email
W.Matthys@umcutrecht.nl
First Name & Middle Initial & Last Name & Degree
Herman van Engeland, M.D., Ph.D.
Phone
31-302506362
Email
H.VanEngeland@umcutrecht.nl
First Name & Middle Initial & Last Name & Degree
Walter Matthys, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Maartje Raaijmakers, M.Sc.
First Name & Middle Initial & Last Name & Degree
Jocelyne Posthumus, M.Sc.
12. IPD Sharing Statement
Citations:
PubMed Identifier
9103739
Citation
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.
Results Reference
background
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Prevention of Oppositional Defiant and Conduct Disorders in Preschool Children
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