Evaluation of a Home Visiting Program for First Time Parents

This study has been completed.
Sponsor:
Collaborators:
The Duke Endowment
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00579449
First received: December 20, 2007
Last updated: March 13, 2014
Last verified: March 2014

December 20, 2007
March 13, 2014
March 2005
December 2011   (final data collection date for primary outcome measure)
Durham County, North Carolina Department of Social Services reports of child maltreatment [ Time Frame: 2011 ] [ Designated as safety issue: No ]
Durham County, NC Department of Social Services reports of child maltreatment [ Time Frame: 2011 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00579449 on ClinicalTrials.gov Archive Site
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Evaluation of a Home Visiting Program for First Time Parents
Evaluation of a Home Visiting Program for First Time Parents

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.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Child Abuse
  • Behavioral: Healthy Families Durham
    Implementation of Healthy Families America program plus Parents As Teachers curriculum
  • Behavioral: Yearly Checkup
    Mother and child are assessed annually and based on responses and stated needs, referrals to community resources are made.
    Other Name: case management
  • Active Comparator: HF 36
    For those randomly assigned to the 3-year HFD group, services begin during the third trimester of pregnancy. These families are assigned a Family Support Worker, who begins to initiate contact with the family at approximately 6 months gestation, when possible, so that the family can be engaged and services begun at seven months gestation. The Family Support Worker will provide home visiting services according the existing HFD model, which combines the empirically supported Parents as Teachers Curriculum (see attached description of the Parents as Teachers curriculum) provided in accordance with Healthy Families America standards of service delivery. The 3-year HFD group will receive services to the child's third birthday.
    Intervention: Behavioral: Healthy Families Durham
  • Active Comparator: HF 18
    For those randomly assigned to the 18-month HFD group, services begin during the third trimester of pregnancy. These families are assigned a Family Support Worker, who begins to initiate contact with the family at approximately 6 months gestation, so that the family can be engaged and services begun at seven months gestation. The Family Support Worker will provide home visiting services according the existing HFD model, which combines the empirically supported Parents as Teachers Curriculum (see attached description of the Parents as Teachers curriculum) provided in accordance with Healthy Families America standards of service delivery. Services for this group are terminated when the child is 18 months old, with clinically necessary referrals made for ongoing psychosocial and health needs.
    Intervention: Behavioral: Healthy Families Durham
  • Active Comparator: YC
    For those assigned to the Yearly Checkup group, a clinically-trained member of the HFD team will make yearly home visits to conduct the evaluation assessment. Information about community services and assistance with referrals are provided based on needs identified.
    Intervention: Behavioral: Yearly Checkup
  • No Intervention: MCC
    Women placed in the community services as usual (Maternity Care Coordination only) group will receive no additional services or assessments as a part of this study.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
343
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Female
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00579449
Pro00014616 (6997), 5K01MH70378-3
No
Duke University
Duke University
  • National Institute of Mental Health (NIMH)
  • The Duke Endowment
Principal Investigator: Robert Murphy, Ph.D. Duke University
Principal Investigator: Kenneth Dodge, Ph.D. Duke University
Duke University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP