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Study of Children at Risk for Disruptive Behavior Disorders

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ClinicalTrials.gov Identifier: NCT00001233
Recruitment Status : Completed
First Posted : December 10, 2002
Last Update Posted : March 4, 2008
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Tracking Information
First Submitted Date November 3, 1999
First Posted Date December 10, 2002
Last Update Posted Date March 4, 2008
Study Start Date December 1988
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Children at Risk for Disruptive Behavior Disorders
Official Title A Longitudinal Study of Children at Risk for Disruptive Behavior Disorders: Transitions From Early Childhood to Middle Childhood and Adolescence
Brief Summary

A conduct disorder is characterized by repetitive and persistent patterns of behavior where the basic rights of others and rules are violated.

This study investigates characteristics of children and their surroundings (environments) that place them at risk for the development of disruptive behavior disorders and associated disorders of anxiety and mood. Children ages 4 - 5 with moderate (subclinical) and severe (clinical) rates of misconduct during the preschool period are compared to low risk children. Children and their families were recruited from 1989-1991 and are being studied at five specific times:

  1. Preschool (4 - 5 years)
  2. Early childhood (6 - 7 years)
  3. Middle childhood (9 - 10 years)
  4. Early adolescence (13 - 14 years)
  5. Mid-adolescence (15 - 16 years)

Researchers will look closely at biological, intellectual, emotional, and behavioral factors that are thought to protect against and/or increase the risk of developing a conduct problem. These factors have been studied in older children and are shown to be associated with disruptive behavior disorders.

The goals of this research study are;

  1. Create a database showing the characteristics of the development of disruptive behavior problems.
  2. Identify the key risk and protective factors that contribute to the stability or change in behavior problems over time.
  3. Identify the ways that children interact socially and relate them to the possibility of developing a problem of behavior.
  4. Identify how experiences and the emotions associated with experiences may play a role in the development of related psychiatric conditions, like depression and anxiety.
  5. Establish measures of the different components of negative emotions associated with disruptive/antisocial, anxiety, and mood disorders.
Detailed Description This study investigates characteristics of children and their environments that place them at risk for the development of disruptive behavior disorders and co-morbid internalizing problems (anxiety and mood disorders). Children ages 4-5 with moderate (subclinical) and high (clinical) rates of misconduct during the preschool period are compared with low risk children. Children and their families are studied again at four later time points: (a) early childhood (6-7 yrs.), (b) middle childhood (9-10 yrs.), (c) early adolescence (13-14 yrs.), and (d) mid-adolescence (15-16 yrs.). Assessments of children include dimensions of biological, cognitive, affective, emotional and behavioral functioning, that have been identified in research with older children as putative risk and protective factors in the development of conduct problems. Socialization experiences within and outside the family, also hypothesized to influence developmental trajectories are examined. Currently, Time 4 assessments are being conducted, with three-quarters of the research subjects tested. Behavior problems show significant stability across the first three time periods. However, some children improve over time, changes that result, in part, from more optimal environmental conditions. Different patterns of emotion dysregulation, ANS, and HPA activity in antisocial preschool children predict different types of externalizing problems at later time points. Behavior problems and their correlates differ for young disruptive boys and girls: Oppositional, aggressive girls are more likely to have co-morbid internalizing problems, and emotion regulation patterns that may decrease risk for continued antisocial behavior, but increase risk for depression and anxiety later in development.
Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Attention Deficit and Disruptive Behavior Disorders
  • Child Behavior Disorders
  • Passive-Aggressive Personality Disorder
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment
 (submitted: June¬†23,¬†2005)
900
Original Enrollment Same as current
Study Completion Date December 2000
Primary Completion Date Not Provided
Eligibility Criteria Preschool age children with conduct problems and normal preschool age children used for control.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00001233
Other Study ID Numbers 880217
88-M-0217
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor National Institute of Mental Health (NIMH)
Collaborators Not Provided
Investigators Not Provided
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date January 2000