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Main
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Note: This record shows only 22 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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19 February 2015 |
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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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Prospective Registration:
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No |
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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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Phase:
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Phase 2/Phase 3
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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 depression
[Time Frame: At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years]
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Child social-emotional development
[Time Frame: At-risk sample: Up to 6 years; Not-at risk sample: Up to 1 year]
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Child cognitive development, behavior, and health
[Time Frame: At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years]
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Secondary Outcome(s)
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Family functioning
[Time Frame: At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years]
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Parent functioning and stress levels
[Time Frame: At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years]
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Substantiated reports of child abuse
[Time Frame: At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years]
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Secondary ID(s)
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R01MH060733
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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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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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