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NCT00438516 · ClinicalTrials.gov registry record · NA

Follow-up of Families in Early Preventive Intervention

A NA study of Risk Reduction Behavior and Adolescent Development, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Completed
Registry status
NA
Development phase
627
Enrollment target
1
Study location

NCT00438516 is a NA study of Risk Reduction Behavior and Adolescent Development that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 627 participants, below the 5,856-participant average among 9 other Risk Reduction Behavior trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00438516, a NA study of Risk Reduction Behavior and Adolescent Development, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

COMPLETED
Registry status
NA
Development phase
627 participants
Enrollment target
1
Study location

Study Summary

This project supports the post-third-grade assessment of 693 children and their families who were enrolled in a randomized trial of a program of prenatal and infancy home visitation by nurses that was epidemiologically and theoretically grounded. The project will determine whether the beneficial effects of the program on maternal, child, and family functioning extend through the early elementary school years, giving particular attention to maternal life-course and children's emerging antisocial behavior. Assessments of the children will be based on both mother and teacher reports. Teachers are independent, natural raters of the children's adaptation to an important social context. There are numerous reasons to expect that, from a developmental perspective, the effects of the program will increase as children experience the increased academic demands associated with entry into third grade. In addressing these questions, the current study will determine the extent to which this program of prenatal and infancy home visitation by nurses can produce enduring effects on maternal and child functioning (giving particular attention to the prevention of early-onset disruptive behavior disorders) in urban African Americans that are consistent with those achieved with whites in a central New York state county in a separate trial of this program conducted over the past 20 years.

Interventions

  • BEHAVIORAL nurse home visitation

Study Locations (1)

New York

  • University of Rochester School of Nursing - Rochester

Trial Details

FieldValue
Enrollment Target 627 participants
Start Date 2000-06
Est. Completion 2003-03
Phase NA

What the Registry Record Tells You About NCT00438516

The ClinicalTrials.gov registry entry for NCT00438516 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 627 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,856-participant average among 9 other Risk Reduction Behavior trials with a reported enrollment target (89% lower). The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Risk Reduction Behavior appearing as the primary indexed condition, and to 1 intervention - of which nurse home visitation is the first listed.

NCT00438516 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT00438516 about?

NCT00438516 is a clinical study titled "Follow-up of Families in Early Preventive Intervention". This project supports the post-third-grade assessment of 693 children and their families who were enrolled in a randomized trial of a program of prenatal and infancy home visitation by nurses that was epidemiologically and theoretically grounded. The project will determine whether the beneficial eff...

What is the current status of trial NCT00438516?

This trial is currently completed. It is a NA study. The enrollment target is 627 participants. The study started on 2000-06. Estimated completion is 2003-03.

What conditions does trial NCT00438516 study?

This clinical trial studies the following conditions: Risk Reduction Behavior, Adolescent Development, Reproductive Behavior, Child Rearing.

What interventions are being tested in trial NCT00438516?

The interventions under investigation include: nurse home visitation (BEHAVIORAL).

Who is sponsoring clinical trial NCT00438516?

This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00438516 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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