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NCT00579449 Clinical Trial

Evaluation of a Home Visiting Program for First Time Parents

Child Abuse Clinical Trial

Official title:
Evaluation of a Home Visiting Program for First Time Parents

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00579449
Other study ID # Pro00014616
Secondary ID 5K01MH70378-3699
Status Completed
Phase N/A
First received December 20, 2007
Last updated September 19, 2014
Start date March 2005
Est. completion date December 2011

Study information
Verified date September 2014
Source Duke University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this research is to evaluate the Healthy Families Durham (HFD) program by comparing the traditional 3-year program to 18-months of Healthy Families Durham to Yearly Visits with case management referrals to community services as usual, and to determine whether participation in the program reduces the number of reports for child maltreatment within the first seven years of the child's life.

Recruitment information / eligibility
Status Completed
Enrollment 343
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- mother is a first-time parent (has been a primary caregiver of a child for less than 3 months total

- resident of Durham, North Carolina

- mother is being referred during pregnancy

- has at least one of the following risk factors: 16 years old or younger; lack of social support; history of substance abuse in the past 12 months; ever received treatment for alcohol or drug problems; history of domestic violence; history of being abused or neglected as a child; history of mental health problems in past 12 months; past child protective services involvement as a parent

Exclusion Criteria:

- actively suicidal or homicidal

- acutely psychotic

- moderately to severely mentally retarded

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• Healthy Families Durham
Implementation of Healthy Families America program plus Parents As Teachers curriculum
• Yearly Checkup
Mother and child are assessed annually and based on responses and stated needs, referrals to community resources are made.

Locations
Country Name City State
United States Center for Child and Family Health Durham North Carolina

Sponsors (3)
Lead Sponsor Collaborator
Duke University National Institute of Mental Health (NIMH), The Duke Endowment

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Durham County, North Carolina Department of Social Services reports of child maltreatment 2011 No
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