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

NCT ID: NCT01692288

Last Updated: 2017-01-06

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

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Infant Health Risk Factors

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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Offered First Born® Program services

Family and first-born child are selected to be offered First Born® Program home visiting services.

Group Type EXPERIMENTAL

First Born® Program home visiting services

Intervention Type BEHAVIORAL

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.

Not offered First Born® Program services

Family and first-born child are not selected to be offered First Born® Program home visiting services.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Maximum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RAND

OTHER

Sponsor Role lead

Responsible Party

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Rebecca Kilburn

Senior Economist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rebecca Kilburn, PhD

Role: PRINCIPAL_INVESTIGATOR

RAND

Locations

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United Way of Santa Fe County First Born® Program

Santa Fe, New Mexico, United States

Site Status

Countries

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United States

References

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Kilburn MR, Cannon JS. Home Visiting Start-Up: Lessons Learned From Program Replication in New Mexico. J Prim Prev. 2015 Aug;36(4):275-9. doi: 10.1007/s10935-015-0392-5.

Reference Type BACKGROUND
PMID: 25921835 (View on PubMed)

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

Reference Type BACKGROUND

Kilburn MR, Cannon JS. Home Visiting and Use of Infant Health Care: A Randomized Clinical Trial. Pediatrics. 2017 Jan;139(1):e20161274. doi: 10.1542/peds.2016-1274. Epub 2016 Dec 15.

Reference Type RESULT
PMID: 27980028 (View on PubMed)

Other Identifiers

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K7051-07-03

Identifier Type: -

Identifier Source: org_study_id

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