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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 3, 1999 |
| Last Updated Date | March 3, 2008 |
| Start Date ICMJE | December 1988 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00001233 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Study of Children at Risk for Disruptive Behavior Disorders |
| Official Title ICMJE | 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:
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;
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| 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 Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | |
| Condition ICMJE |
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| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 900 |
| Completion Date | December 2000 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Preschool age children with conduct problems and normal preschool age children used for control. |
| Gender | Both |
| Ages | |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00001233 |
| Responsible Party | |
| Study ID Numbers ICMJE | 880217, 88-M-0217 |
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | January 2000 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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