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

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ClinicalTrials.gov Identifier: NCT01692288
Recruitment Status : Completed
First Posted : September 25, 2012
Last Update Posted : January 6, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Infant Health Risk Factors Behavioral: First Born® Program home visiting services

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 278 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2012
Primary Completion Date : April 2015
Study Completion Date : April 2015
Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. Number of participants with child health or development risk factors [ Time Frame: First year of life ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Kilburn, M.R. Lessons from the randomized trial evaluation of a new parent program: when the evaluators see the glass as half full, and the community sees the glass as half empty. J Exp Criminol (2012) 8: 255. doi:10.1007/s11292-012-9152-1

Responsible Party: Rebecca Kilburn, Senior Economist, RAND
ClinicalTrials.gov Identifier: NCT01692288     History of Changes
Other Study ID Numbers: K7051-07-03
First Posted: September 25, 2012    Key Record Dates
Last Update Posted: January 6, 2017
Last Verified: January 2017