<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/NCT01707173</url>
  </required_header>
  <id_info>
    <org_study_id>1R01HD064770-01A1</org_study_id>
    <secondary_id>HUM00048679</secondary_id>
    <secondary_id>R01HD064770</secondary_id>
    <nct_id>NCT01707173</nct_id>
  </id_info>
  <brief_title>Improving the Self-Efficacy of African American Parents in Infant Supine Sleep</brief_title>
  <acronym>PrAAIS</acronym>
  <official_title>Improving the Self-Efficacy of African American Parents in Infant Supine Sleep</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a research study of African American parents/caregivers of newborns. The purpose of&#xD;
      this research study is to learn what type of educational materials about infant safety and&#xD;
      safe infant sleep are most effective and acceptable to parents and caregivers. The&#xD;
      investigators will compare the responses of parents who receive enhanced materials to the&#xD;
      responses of parents who receive the ordinary materials that are currently in use.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of the proposed research is to determine whether a tailored multi-media mailed&#xD;
      intervention is superior to standard non-tailored print brochures along with a generic DVD in&#xD;
      increasing the prevalence of African American infant supine sleep during the first six months&#xD;
      of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Infant's usual sleep position per parental report</measure>
    <time_frame>Change in position from study entry to infant ages 3 months and to six months; change in position from infant ages 3 months to 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Infants position for last night's sleep per parental report</measure>
    <time_frame>Change in position from study entry to infant ages 3 months and six months; change in position from infant age 3 months to 6 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">735</enrollment>
  <condition>African American Infant Sleep Beliefs and Practices</condition>
  <arm_group>
    <arm_group_label>Standard Education</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Control group participants will receive standard educational materials published by the CDC or American Academy of Pediatrics as an intervention along with a generic infant safety DVD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tailored education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Parents/caregivers will receive educational materials tailored to their specific beliefs and barriers about infant supine sleep along with a DVD detailing standard guidelines along with specific solutions and facilitators to infant supine sleep as the intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tailored education</intervention_name>
    <description>Using information gleaned from interviews, educational print materials tailored to the participant's beliefs about infant safe sleep practices, will be mailed to the participants home at 2 separate times over a 6 month period along with a culturally relevant DVD with safe sleep information</description>
    <arm_group_label>Tailored education</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Education</intervention_name>
    <description>Participants will receive currently available publications about infant sleep from the American Academy of Pediatrics and the AAP at 2 separate times over a 6 month period along with a generic DVD about infant safety practices</description>
    <arm_group_label>Standard Education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:-&#xD;
&#xD;
        - Self-identified AA adult parents and primary caregivers (≥ 18 years of age) of newborns ≤&#xD;
        four weeks old at the time of the infant's first office visit to the pediatrician.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Foster parents and temporary guardians:&#xD;
&#xD;
          -  Prior study participants:&#xD;
&#xD;
          -  Parents without a reliable phone number:&#xD;
&#xD;
          -  Parents without ready access to a DVD player: an ownership of a DVD player,&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathryn L Moseley, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Child Health Evaluation and Research Unit, University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109-0456</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>June 1, 2016</last_update_submitted>
  <last_update_submitted_qc>June 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 3, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Kathryn Moseley, MD, MPH</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>SIDS</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/NCT01707173
org study id: 1R01HD064770-01A1
secondary id: HUM00048679
secondary id: R01HD064770
nct id: NCT01707173
lead sponsor: 
collaborator: 
has dmc: Yes
This is a research study of African American parents/caregivers of newborns. The purpose of
      this research study is to learn what type of educational materials about infant safety and
      safe infant sleep are most effective and acceptable to parents and caregivers. The
      investigators will compare the responses of parents who receive enhanced materials to the
      responses of parents who receive the ordinary materials that are currently in use.
The goal of the proposed research is to determine whether a tailored multi-media mailed
      intervention is superior to standard non-tailored print brochures along with a generic DVD in
      increasing the prevalence of African American infant supine sleep during the first six months
      of life.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Infant's usual sleep position per parental report
time frame: Change in position from study entry to infant ages 3 months and to six months; change in position from infant ages 3 months to 6 months
measure: Infants position for last night's sleep per parental report
time frame: Change in position from study entry to infant ages 3 months and six months; change in position from infant age 3 months to 6 months
arm group label: Standard Education
arm group type: Other
description: Control group participants will receive standard educational materials published by the CDC or American Academy of Pediatrics as an intervention along with a generic infant safety DVD
arm group label: Tailored education
arm group type: Experimental
description: Parents/caregivers will receive educational materials tailored to their specific beliefs and barriers about infant supine sleep along with a DVD detailing standard guidelines along with specific solutions and facilitators to infant supine sleep as the intervention.
intervention type: Behavioral
intervention name: Tailored education
description: Using information gleaned from interviews, educational print materials tailored to the participant's beliefs about infant safe sleep practices, will be mailed to the participants home at 2 separate times over a 6 month period along with a culturally relevant DVD with safe sleep information
arm group label: Tailored education
intervention type: Behavioral
intervention name: Standard Education
description: Participants will receive currently available publications about infant sleep from the American Academy of Pediatrics and the AAP at 2 separate times over a 6 month period along with a generic DVD about infant safety practices
arm group label: Standard Education
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kathryn L Moseley, MD, MPH
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Kathryn Moseley, MD, MPH
investigator title: Assistant Professor