Evaluation of a Home Visiting Program for First Time Parents

NCT ID: NCT00579449

Last Updated: 2014-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

343 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Child Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Healthy Families Durham

Intervention Type BEHAVIORAL

Implementation of Healthy Families America program plus Parents As Teachers curriculum

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.

Group Type ACTIVE_COMPARATOR

Healthy Families Durham

Intervention Type BEHAVIORAL

Implementation of Healthy Families America program plus Parents As Teachers curriculum

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.

Group Type ACTIVE_COMPARATOR

Yearly Checkup

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Healthy Families Durham

Implementation of Healthy Families America program plus Parents As Teachers curriculum

Intervention Type BEHAVIORAL

Yearly Checkup

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

Intervention Type BEHAVIORAL

Other Intervention Names

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case management

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

The Duke Endowment

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Murphy, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Duke University

Kenneth Dodge, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Center for Child and Family Health

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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5K01MH70378-3

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

6997

Identifier Type: OTHER

Identifier Source: secondary_id

5K01MH070378

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00014616

Identifier Type: -

Identifier Source: org_study_id

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