Evaluation of a Home Visiting Program for First Time Parents

Duke University

Status: Completed

Conditions: Child Abuse

Treatments: Behavioral: Healthy Families Durham; Behavioral: Yearly Checkup

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00579449

6997 (Other Identifier)

5K01MH70378-3 (Other Grant/Funding Number)

Pro00014616

Details and patient eligibility

About

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.

Enrollment: 343 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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343 participants in 4 patient groups

HF 36

Active Comparator group

Description:

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.

Treatment:

Behavioral: Healthy Families Durham

HF 18

Active Comparator group

Description:

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.

Treatment:

Behavioral: Healthy Families Durham

YC

Active Comparator group

Description:

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.

Treatment:

Behavioral: Yearly Checkup

MCC

No Intervention group

Description:

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.