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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Rebecca Kilburn, RAND
ClinicalTrials.gov Identifier:
NCT01692288
First received: September 14, 2012
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Infant Health Risk Factors
Behavioral: First Born® Program home visiting services

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of the Effectiveness of the First Born® Program for New Parents in Santa Fe County, New Mexico

Further study details as provided by RAND:

Primary Outcome Measures:
  • Number of participants with child health or development risk factors [ Time Frame: First year of life ] [ Designated as safety issue: No ]

Estimated Enrollment: 280
Study Start Date: September 2012
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   up to 2 Months
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692288

Locations
United States, New Mexico
United Way of Santa Fe County First Born® Program
Santa Fe, New Mexico, United States, 87501
Sponsors and Collaborators
RAND
Investigators
Principal Investigator: Rebecca Kilburn, PhD RAND
  More Information

No publications provided

Responsible Party: Rebecca Kilburn, Senior Economist, RAND
ClinicalTrials.gov Identifier: NCT01692288     History of Changes
Other Study ID Numbers: K7051-07-03
Study First Received: September 14, 2012
Last Updated: May 8, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 29, 2014