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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 3, 1999 |
| Last Updated Date | March 3, 2008 |
| Start Date ICMJE | October 1979 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00001170 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Study of the Psychological Development of Children of Parents With and Without Affective Disorders |
| Official Title ICMJE | Affective Disorders and Affective Development: A Study of Child Rearing and Child Development in Normal Families and Families With Affective Disorders |
| Brief Summary | This research study is the continuation of a study started more than 20 years ago. The study was designed to explore the effect that depressed parents have on their children and to better understand the factors that contribute to depression development and maintenance. The study will continue to investigate if children have certain characteristics in early and middle childhood that predict the later development of psychological disorders. In addition, the study will continue looking at the processes responsible for the development of children of parents with and without affective (mood) disorders. |
| Detailed Description | The psychological development of offspring of parents with and without affective disorder is assessed from early childhood to young adulthood. Parents with a diagnosis of major depression or bipolar illness and well parents and their children are studied (SADS-L, RDC, and SCID, DSM-III). A sibling pair is studied in each family. Parent-child interaction is investigated through direct observation of behavior in naturalistic and controlled settings. Family history information is obtained through parent interviews. Behavioral observations, standard tests, physical examinations, and psychiatric interviews, and MRI procedures provide multiple assessments of the offspring. The study has been completed through preadolescence, adolescence, and late adolescence. Follow-up in young adulthood continues. |
| 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 | 1045 |
| Completion Date | February 2005 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Patients will be drawn from an ongoing longitudinal study begun in 1979 of offspring of parents with affective illness (unipolar and bipolar) and children of normal control parents. |
| 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 | NCT00001170 |
| Responsible Party | |
| Study ID Numbers ICMJE | 790123, 79-M-0123 |
| 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 | February 2005 |
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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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