Evaluation of the Effectiveness of a Home Visiting Program for New Parents in New Mexico

January 4, 2017 updated by: Rebecca Kilburn, RAND

Evaluation of the Effectiveness of the First Born® Program for New Parents in Santa Fe County, New Mexico

The purpose of this study is to determine if children and mothers who participate in the First Born® Program (FBP) experience better outcomes than they would have in the absence of the program. The evaluation employs a randomized trial design to assess the effectiveness of the FBP in the Santa Fe County, NM, site. FBP is a home visitation program that uses clinically trained professionals to provide first-time parents with information, training, and access to resources designed to promote early childhood development. Services are free and may begin at any time during pregnancy or up to two months after the baby's birth and may continue until the child is three years old. In addition, a nurse postpartum home visit is offered to the parents of all participating newborns. The FBP model builds on other home visiting and prevention programs that have been shown to improve long-term outcomes of children and their families.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

278

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Santa Fe, New Mexico, United States, 87501
        • United Way of Santa Fe County First Born® Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 months (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • First-time parent
  • Mother is currently pregnant or child is less than two months old
  • Lives within Santa Fe County, New Mexico
  • Parent accepts referral to First Born Program

Exclusion Criteria:

  • Child is not first born
  • First-born child is two months or older
  • Parent resides outside Santa Fe County
  • Parent has not been referred to First Born Program

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Offered First Born® Program services
Family and first-born child are selected to be offered First Born® Program home visiting services.
Behavioral: First Born® Program home visiting services
Family and first-born child are offered and/or receive weekly First Born® Program home visiting services between pregnancy and the child's third birthday. Families are eligible to enroll in the program from pregnancy up to two months after birth.
No Intervention: Not offered First Born® Program services
Family and first-born child are not selected to be offered First Born® Program home visiting services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with child health or development risk factors
Time Frame: First year of life
First year of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RAND

Investigators

  • Principal Investigator: Rebecca Kilburn, PhD, RAND

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

September 14, 2012

First Submitted That Met QC Criteria

September 20, 2012

First Posted (Estimate)

September 25, 2012

Study Record Updates

Last Update Posted (Estimate)

January 6, 2017

Last Update Submitted That Met QC Criteria

January 4, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • K7051-07-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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