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
  Purpose

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.


Condition Intervention
Child Abuse
Behavioral: Healthy Families Durham
Behavioral: Yearly Checkup

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of a Home Visiting Program for First Time Parents

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Durham County, North Carolina Department of Social Services reports of child maltreatment [ Time Frame: 2011 ] [ Designated as safety issue: No ]

Enrollment: 343
Study Start Date: March 2005
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Healthy Families Durham
Implementation of Healthy Families America program plus Parents As Teachers curriculum
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.
Behavioral: Healthy Families Durham
Implementation of Healthy Families America program plus Parents As Teachers curriculum
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.
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
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00579449

Locations
United States, North Carolina
Center for Child and Family Health
Durham, North Carolina, United States, 27701
Sponsors and Collaborators
Duke University
The Duke Endowment
Investigators
Principal Investigator: Robert Murphy, Ph.D. Duke University
Principal Investigator: Kenneth Dodge, Ph.D. Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00579449     History of Changes
Other Study ID Numbers: Pro00014616 (6997), 5K01MH70378-3
Study First Received: December 20, 2007
Last Updated: March 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
child abuse
child neglect

ClinicalTrials.gov processed this record on April 16, 2014