Evaluation of a Home Visiting Program for First Time Parents

NCT00579449 | Completed

• 4 other identifiers: Pro000146165K01MH70378-369975K01MH070378
• Study Type: interventional
• Target: 343
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Child Abuse

Keywords

child abuse; child neglect

Outcome Measures

Primary Outcomes (1)

• Durham County, North Carolina Department of Social Services reports of child maltreatment

  2011

Study Arms (4)

HF 36

ACTIVE COMPARATOR

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

HF 18

ACTIVE COMPARATOR

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

YC

ACTIVE COMPARATOR

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

MCC

NO INTERVENTION

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.

Interventions

Healthy Families Durham BEHAVIORAL

Implementation of Healthy Families America program plus Parents As Teachers curriculum

HF 18; HF 36

Yearly Checkup BEHAVIORAL

Mother and child are assessed annually and based on responses and stated needs, referrals to community resources are made.

Also known as: case management

YC

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• actively suicidal or homicidal
• acutely psychotic
• moderately to severely mentally retarded

Sponsors & Collaborators

• Duke University: lead
• National Institute of Mental Health (NIMH): collaborator
• The Duke Endowment: collaborator

Study Sites (1)

Center for Child and Family Health

Durham, North Carolina, 27701, United States

Location

MeSH Terms

Interventions

Case Management

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Robert Murphy, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

• Kenneth Dodge, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 24, 2007
• Study Start: March 1, 2005
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: September 22, 2014

Record last verified: 2014-09

Locations

US (1)