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Oppositional Defiant DisorderNCT00189189

Prevention of Oppositional Defiant and Conduct Disorders in Preschool Children

A study testing parent management training in people with Oppositional Defiant Disorder and Conduct Disorder, run by UMC Utrecht at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 5 yearsHealthy volunteers can take part
What is being tested?
parent management training
How many people
160 participants
Where
1 siteNetherlands
Study dates
Jul 2003to Nov 2008
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 5 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Aggression score on Child Behavior Checklist (CBCL) of at least 80th percentile
  • Age of child: between 4 and 5 years old

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Walter Matthys, M.D., Ph.D. contact

31-302507045

W.Matthys@umcutrecht.nl

Netherlands1 site, 1 recruiting
  • University Medical Centre Utrecht

    Utrecht, Utrecht, 3508 GA

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

    Herman van Engeland, M.D., Ph.D., 31-302506362, H.VanEngeland@umcutrecht.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: Parent Management Training to Prevent Oppositional Defiant and Conduct Disorders in Preschool Children

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.

Being tested
parent management training
Keywords
prevention, oppositional defiant disorder, conduct disorder
Medical subject headings
Oppositional Defiant Disorder, Conduct Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • parent management trainingBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

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

  2. Teacher questionnaire (TRF)

Secondary outcomes (1)
  1. Cost-effectiveness

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2005 (estimated)
  2. Study startJul 2003
  3. Study completionNov 2008 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00189189
Sponsor's protocol ID
03-119
Other IDs
ZonMw: 2620.0001
Status last verified
Jul 2005
First submitted
13 Sep 2005
Last updated
2 Oct 2007
Results posted
No

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

Questions about this trial

What is this clinical trial studying?

A study testing parent management training in people with Oppositional Defiant Disorder and Conduct Disorder, run by UMC Utrecht at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Walter Matthys, M.D., Ph.D. (31-302507045, W.Matthys@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite score consisting of DPICS (behavioral observation) and parent questionnaires (CBCL, Eyberg). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00189189, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2007.

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