<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/NCT01726062</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-MS-11-0641</org_study_id>
    <secondary_id>1R01HL107404-01A1</secondary_id>
    <nct_id>NCT01726062</nct_id>
  </id_info>
  <brief_title>Motivational Incentives to Reduce Secondhand Smoke in NICU Infants' Homes</brief_title>
  <official_title>Motivational Incentives to Reduce Secondhand Smoke in NICU Infants' Homes (The Baby's Breath II Project)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Memorial Hermann Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Texas Health Science Center, Houston</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized, controlled, parallel group design will be used to test whether a Secondhand&#xD;
      Smoke Exposure program initiated in the hospital and completed in the home using motivational&#xD;
      interviewing plus motivational incentives (MI+) is more effective than Conventional Care (CC)&#xD;
      with Neonatal Incentives Care Unit Infants' parents.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2012</start_date>
  <completion_date type="Actual">January 30, 2018</completion_date>
  <primary_completion_date type="Actual">January 30, 2018</primary_completion_date>
  <phase>Phase 2</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Infant Second-Hand Smoke Exposure via Urine Cotinine</measure>
    <time_frame>Follow-up visit 4 months post-treatment</time_frame>
    <description>Infant Second-Hand Smoke Exposure (SHSe) measures will be determined via urine cotinine.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondhand Smoke Exposure outcomes</measure>
    <time_frame>Change from Baseline to the 4 months post-treatment followup</time_frame>
    <description>Primary caregiver reports via the Timeline Follow-Back and household air nicotine monitors. Number of cigarettes smoked outdoors vs. indoor and the implementation of household smoking bans will also be assessed. Primary caregivers will complete the SHSe related interviews and self-report questionnaires. Primary caregivers who are smokers will complete measures related to smoking and smoking cessation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">360</enrollment>
  <condition>Exposure to Secondhand Smoke in Neonatal Infants</condition>
  <arm_group>
    <arm_group_label>Motivational Interviewing plus Incentives</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Care (CC)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motivational Interviewing plus Incentives</intervention_name>
    <description>Two hospital-based, face-to-face MI+ sessions&#xD;
Two home-based MI+ sessions&#xD;
Attendance at each session and for the establishment of a household smoking ban at two timepoints post-discharge</description>
    <arm_group_label>Motivational Interviewing plus Incentives</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Conventional Care (CC)</intervention_name>
    <description>Participants in this arm will receive brochures and a brief information meeting in the NICU.</description>
    <arm_group_label>Conventional Care (CC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have an infant that is at least 1 week prior to the estimated date of hospital&#xD;
             discharge in the NICU at Children's Memorial Hermann Hospital (CMHH)&#xD;
&#xD;
          -  Report at least one person living in the home who smokes&#xD;
&#xD;
          -  Agree to attend intervention sessions and to invite other household members&#xD;
&#xD;
          -  Live within 50 miles of our center&#xD;
&#xD;
          -  Have access to a telephone.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe cognitive, and/or psychiatric impairment, per judgment of NICU and research&#xD;
             staff, that precludes cooperation with study protocol&#xD;
&#xD;
          -  Inability to read, write, and speak English or Spanish&#xD;
&#xD;
          -  Inability or unwillingness to provide signed consent for participation&#xD;
&#xD;
          -  Inability or unwillingness to meet study requirements, including home visits for data&#xD;
             collection and intervention purposes.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Angela Stotts, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas at Houston Family and Community Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Memorial Hermann Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>May 8, 2018</last_update_submitted>
  <last_update_submitted_qc>May 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
    <investigator_full_name>Angela Stotts</investigator_full_name>
    <investigator_title>Associate Professor - Family Medicine</investigator_title>
  </responsible_party>
  <keyword>Motivational Incentives</keyword>
  <keyword>Motivational Interviewing</keyword>
  <keyword>Secondhand Smoke</keyword>
  <keyword>Neonatal Intensive Care Unit</keyword>
  <keyword>NICU</keyword>
  <keyword>High respiratory risk infants</keyword>
  <keyword>Low birth weight infants</keyword>
  <keyword>Environmental Tobacco Smoke</keyword>
  <keyword>Smoking</keyword>
  <keyword>Contingency management</keyword>
  <keyword>Infants</keyword>
  <keyword>Children</keyword>
  <!-- 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/NCT01726062
org study id: HSC-MS-11-0641
secondary id: 1R01HL107404-01A1
nct id: NCT01726062
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
A randomized, controlled, parallel group design will be used to test whether a Secondhand
      Smoke Exposure program initiated in the hospital and completed in the home using motivational
      interviewing plus motivational incentives (MI+) is more effective than Conventional Care (CC)
      with Neonatal Incentives Care Unit Infants' parents.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Infant Second-Hand Smoke Exposure via Urine Cotinine
time frame: Follow-up visit 4 months post-treatment
description: Infant Second-Hand Smoke Exposure (SHSe) measures will be determined via urine cotinine.
measure: Secondhand Smoke Exposure outcomes
time frame: Change from Baseline to the 4 months post-treatment followup
description: Primary caregiver reports via the Timeline Follow-Back and household air nicotine monitors. Number of cigarettes smoked outdoors vs. indoor and the implementation of household smoking bans will also be assessed. Primary caregivers will complete the SHSe related interviews and self-report questionnaires. Primary caregivers who are smokers will complete measures related to smoking and smoking cessation.
arm group label: Motivational Interviewing plus Incentives
arm group type: Experimental
arm group label: Conventional Care (CC)
arm group type: Other
intervention type: Behavioral
intervention name: Motivational Interviewing plus Incentives
description: Two hospital-based, face-to-face MI+ sessions
Two home-based MI+ sessions
Attendance at each session and for the establishment of a household smoking ban at two timepoints post-discharge
arm group label: Motivational Interviewing plus Incentives
intervention type: Behavioral
intervention name: Conventional Care (CC)
description: Participants in this arm will receive brochures and a brief information meeting in the NICU.
arm group label: Conventional Care (CC)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Angela Stotts, PhD
role: Principal Investigator
affiliation: University of Texas at Houston Family and Community Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Angela Stotts
investigator title: Associate Professor - Family Medicine