Completed

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

What is being tested

First Born® Program home visiting services

Behavioral

Who is being recruted

Until 2 Months

+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Interventional

Study Start: September 2012

See protocol details

Summary

Principal SponsorRAND

Last updated: January 6, 2017

Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01692288

Principal SponsorRAND

Last updated: January 6, 2017

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

278 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 2 Months

Range of ages for which participants are eligible to join.

Criteria

4 inclusion criteria required to participate

First-time parent

Lives within Santa Fe County, New Mexico

Mother is currently pregnant or child is less than two months old

Parent accepts referral to First Born Program

4 exclusion criteria prevent from participating

Child is not first born

First-born child is two months or older

Parent has not been referred to First Born Program

Parent resides outside Santa Fe County

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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

Group II

No Intervention

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

United Way of Santa Fe County First Born® Program

Santa Fe, United StatesOpen United Way of Santa Fe County First Born® Program in Google Maps

CompletedOne Study Center