<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01692288</url>
  </required_header>
  <id_info>
    <org_study_id>K7051-07-03</org_study_id>
    <nct_id>NCT01692288</nct_id>
  </id_info>
  <brief_title>Evaluation of the Effectiveness of a Home Visiting Program for New Parents in New Mexico</brief_title>
  <official_title>Evaluation of the Effectiveness of the First Born® Program for New Parents in Santa Fe County, New Mexico</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RAND</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RAND</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if children and mothers who participate in the&#xD;
      First Born® Program (FBP) experience better outcomes than they would have in the absence of&#xD;
      the program. The evaluation employs a randomized trial design to assess the effectiveness of&#xD;
      the FBP in the Santa Fe County, NM, site. FBP is a home visitation program that uses&#xD;
      clinically trained professionals to provide first-time parents with information, training,&#xD;
      and access to resources designed to promote early childhood development. Services are free&#xD;
      and may begin at any time during pregnancy or up to two months after the baby's birth and may&#xD;
      continue until the child is three years old. In addition, a nurse postpartum home visit is&#xD;
      offered to the parents of all participating newborns. The FBP model builds on other home&#xD;
      visiting and prevention programs that have been shown to improve long-term outcomes of&#xD;
      children and their families.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with child health or development risk factors</measure>
    <time_frame>First year of life</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">278</enrollment>
  <condition>Infant Health Risk Factors</condition>
  <arm_group>
    <arm_group_label>Offered First Born® Program services</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Family and first-born child are selected to be offered First Born® Program home visiting services.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Not offered First Born® Program services</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Family and first-born child are not selected to be offered First Born® Program home visiting services.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>First Born® Program home visiting services</intervention_name>
    <description>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.</description>
    <arm_group_label>Offered First Born® Program services</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  First-time parent&#xD;
&#xD;
          -  Mother is currently pregnant or child is less than two months old&#xD;
&#xD;
          -  Lives within Santa Fe County, New Mexico&#xD;
&#xD;
          -  Parent accepts referral to First Born Program&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child is not first born&#xD;
&#xD;
          -  First-born child is two months or older&#xD;
&#xD;
          -  Parent resides outside Santa Fe County&#xD;
&#xD;
          -  Parent has not been referred to First Born Program&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>2 Months</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Rebecca Kilburn, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>RAND</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>United Way of Santa Fe County First Born® Program</name>
      <address>
        <city>Santa Fe</city>
        <state>New Mexico</state>
        <zip>87501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>25921835</PMID>
  </reference>
  <reference>
    <citation>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</citation>
  </reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>27980028</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>January 4, 2017</last_update_submitted>
  <last_update_submitted_qc>January 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>RAND</investigator_affiliation>
    <investigator_full_name>Rebecca Kilburn</investigator_full_name>
    <investigator_title>Senior Economist</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01692288
org study id: K7051-07-03
nct id: NCT01692288
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of participants with child health or development risk factors
time frame: First year of life
arm group label: Offered First Born® Program services
arm group type: Experimental
description: Family and first-born child are selected to be offered First Born® Program home visiting services.
arm group label: Not offered First Born® Program services
arm group type: No Intervention
description: Family and first-born child are not selected to be offered First Born® Program home visiting services.
intervention type: Behavioral
intervention name: First Born® Program home visiting services
description: 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.
arm group label: Offered First Born® Program services
criteria: 
gender: All
minimum age: N/A
maximum age: 2 Months
last name: Rebecca Kilburn, PhD
role: Principal Investigator
affiliation: RAND
facility: 
country: United States
citation: 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.
PMID: 25921835
citation: 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
citation: 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.
PMID: 27980028
responsible party type: Principal Investigator
investigator affiliation: RAND
investigator full name: Rebecca Kilburn
investigator title: Senior Economist