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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00218751 |
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Date of registration:
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16/09/2005 |
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Primary sponsor: |
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Public title:
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Early Home Visitation Program to Promote Good Health and Development in Children at Risk for Abuse
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Scientific title:
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Promoting Child Mental Health: RCT of Home Visiting |
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Date of first enrolment:
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March 2000 |
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Target sample size:
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1122 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00218751 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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United States
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Contacts
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Name:
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Anne K. Duggan, ScD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Johns Hopkins University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Families in the Oahu community who delivered newborns between November 1994 and
November 1995
- If enrolled in the control group, must not have been previously enrolled in Hawaii's
Healthy Start Program
Exclusion Criteria:
- Insufficient understanding of English
Age minimum:
14 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Child Abuse
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Intervention(s)
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Behavioral: Home Visiting
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Primary Outcome(s)
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Child cognitive development, behavior, and health; measured when the child is in 1st, 2nd, and 3rd grades
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Child depression; measured when the child is in 2nd grade
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Child social-emotional development; measured when the child is in 1st grade
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Secondary Outcome(s)
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Family functioning; measured when the child is in 1st, 2nd, and 3rd grades
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Parent functioning and stress levels; measured when the child is in 1st, 2nd, and 3rd grades
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Substantiated reports of child abuse; measured when the child is in 1st, 2nd, and 3rd grades
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Secondary ID(s)
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DSIR CT-P
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R01 MH60733
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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