Conduct Disorder Clinical Trial
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.
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.
;
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03535805 -
Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances
|
N/A | |
Recruiting |
NCT05449002 -
Digital Single Session Intervention for Youth Mental Health
|
N/A | |
Withdrawn |
NCT02247986 -
Investigating the Impact of Methylphenidate on Neural Response in Disruptive Behavioral Disorder
|
Phase 1/Phase 2 | |
Recruiting |
NCT04631042 -
Developing Brain, Impulsivity and Compulsivity
|
||
Completed |
NCT02485587 -
Arousal-Biofeedback for the Treatment of Aggressive Behavior in Children and Adolescents
|
N/A | |
Completed |
NCT00819429 -
Supplements and Social Skills Intervention Study
|
N/A | |
Completed |
NCT00626236 -
Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems
|
Phase 2 | |
Completed |
NCT01085305 -
The Effectiveness of Parent-Child Interaction Therapy (PCIT)
|
N/A | |
Completed |
NCT00250354 -
A Study of the Safety and Effectiveness of Risperidone for the Treatment of Conduct Disorder and Other Disruptive Behavior Disorders in Children Ages 5 to 12 With Mild, Moderate, or Borderline Mental Retardation
|
Phase 3 | |
Completed |
NCT00000385 -
Long-Term Lithium Treatment for Aggressive Conduct Disorder
|
Phase 3 | |
Withdrawn |
NCT01443949 -
Teenagers, Drug Addiction, and Reward and Impulse Control
|
||
Completed |
NCT04091633 -
School Health Implementation Network: Eastern Mediterranean
|
N/A | |
Completed |
NCT02563145 -
Real-time fMRI for the Treatment of Aggressive Behavior in Adolescents
|
N/A | |
Completed |
NCT02766101 -
Manville Moves: an Exercise Intervention for Behavioral Regulation Among Children With Behavioral Health Challenges
|
N/A | |
Completed |
NCT00404911 -
Multi-Family Group Therapy for Reducing Behavioral Difficulties in Youth
|
N/A | |
Completed |
NCT00051727 -
Prevention of School Dropout for Mexican American Adolescents
|
Phase 2 | |
Completed |
NCT02998073 -
Investigating Psychosocial Intervention Treatment Response in Justice-Involved Youth With Conduct Disorder
|
N/A | |
Completed |
NCT03292848 -
Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to <13 Years Old) With Central Nervous System Disorders
|
Phase 1 | |
Recruiting |
NCT05637320 -
Big Feelings: A Study on Children's Emotions in Therapy
|
N/A | |
Recruiting |
NCT06373484 -
Matching Assessment and Treatment for Children With Disruptive Behaviour and Their Parents
|
N/A |