xml: <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/NCT06002360</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00015592</org_study_id>
      <nct_id>NCT06002360</nct_id>
    </id_info>
    <brief_title>Reach Out and Read (ROR) in the Neonatal Intensive Care Unit (NICU) Study</brief_title>
    <official_title>The Effect of Reach Out and Read on Home Literacy Scores, Parental Stress, and Parent-Infant Bonding in the Neonatal ICU</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Washington</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Washington</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to learn about the effects of the Reach Out and Read&#xD;
        program on infants and their families in the neonatal ICU. The main goals of this study are:&#xD;
  &#xD;
          -  To complete a needs assessment for literacy interventions in the NICU population through&#xD;
             evaluating baseline home literacy scores.&#xD;
  &#xD;
          -  To evaluate the effects of the ROR intervention on parental stress levels as assessed by&#xD;
             the 6-question State-Trait Anxiety Index (STAI-6)&#xD;
  &#xD;
          -  To evaluate the effects of the ROR intervention on parent-infant bonding by comparing&#xD;
             scores on the 25-item Postpartum Bonding Questionnaire (PBQ)&#xD;
  &#xD;
          -  To evaluate the effects of the ROR intervention on the home literacy environment by&#xD;
             comparing home literacy scores&#xD;
  &#xD;
        Participants will complete three questionnaires that include demographic information, home&#xD;
        literacy scores, the Postpartum Bonding Questionnaire and the State-Trait Anxiety Index; once&#xD;
        at study enrollment, once at 36 weeks corrected gestational age, and once at 3 months&#xD;
        corrected gestational age.&#xD;
  &#xD;
        Researchers will compare the control group (standard care) and a group that receives Reach&#xD;
        Out and Read education to see whether exposure to Reach Out and Read affects literacy&#xD;
        behaviors, parental anxiety, and parent-infant bonding.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 1, 2022</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>To evaluate the effects of the ROR intervention on the home literacy environment by comparing home literacy scores</measure>
      <time_frame>Between enrollment and 3 months corrected gestational age for infant</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>To evaluate the effects of the ROR intervention on parental stress levels as assessed by the 6-question State-Trait Anxiety Index (STAI-6)</measure>
      <time_frame>Between enrollment and 3 months corrected gestational age for infant</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>To evaluate the effects of the ROR intervention on parent-infant bonding by comparing scores on the 25-item Postpartum Bonding Questionnaire (PBQ)</measure>
      <time_frame>Between enrollment and 3 months corrected gestational age for infant</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>To complete a needs assessment for literacy interventions in the NICU population through evaluating baseline home literacy scores.</measure>
      <time_frame>At enrollment</time_frame>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Anxiety</condition>
    <condition>Parent-Child Relations</condition>
    <condition>Literacy</condition>
    <arm_group>
      <arm_group_label>Reach Out and Read</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Families assigned to this group will receive Reach Out and Read education every two weeks between enrollment and when their infant reaches 36 weeks gestation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Standard neonatal care</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Reach Out and Read</intervention_name>
      <description>Families will be provided with a book and ROR programming from trained study team members (either the principal investigator or a research assistant, both of whom are ROR trained). ROR programming will include discussion of current reading practices, anticipatory guidance on the importance and benefits of reading, modeling of active reading, discussion of how to incorporate reading into a daily routine and answering any questions parents/caregivers may have.</description>
      <arm_group_label>Reach Out and Read</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Families of subjects born between 24w0d and 33w6d gestation&#xD;
  &#xD;
            -  Primary language is English or Spanish&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Severe clinical instability such that the principal investigators do not think the&#xD;
               infant will survive to 36 weeks gestation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>14 Days</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Devin McKissic</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Washington</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Devin McKissic</last_name>
      <phone>(206) 300-1239</phone>
      <email>devinam@uw.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Washington Medical Center NICU</name>
        <address>
          <city>Seattle</city>
          <state>Washington</state>
          <zip>98195</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Devin McKissic, MD</last_name>
        <email>devinam@uw.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Washington</investigator_affiliation>
      <investigator_full_name>Devin McKissic</investigator_full_name>
      <investigator_title>Fellow, Neonatology</investigator_title>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06002360
  org study id: STUDY00015592
  nct id: NCT06002360
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to learn about the effects of the Reach Out and Read
        program on infants and their families in the neonatal ICU. The main goals of this study are:
  
          -  To complete a needs assessment for literacy interventions in the NICU population through
             evaluating baseline home literacy scores.
  
          -  To evaluate the effects of the ROR intervention on parental stress levels as assessed by
             the 6-question State-Trait Anxiety Index (STAI-6)
  
          -  To evaluate the effects of the ROR intervention on parent-infant bonding by comparing
             scores on the 25-item Postpartum Bonding Questionnaire (PBQ)
  
          -  To evaluate the effects of the ROR intervention on the home literacy environment by
             comparing home literacy scores
  
        Participants will complete three questionnaires that include demographic information, home
        literacy scores, the Postpartum Bonding Questionnaire and the State-Trait Anxiety Index; once
        at study enrollment, once at 36 weeks corrected gestational age, and once at 3 months
        corrected gestational age.
  
        Researchers will compare the control group (standard care) and a group that receives Reach
        Out and Read education to see whether exposure to Reach Out and Read affects literacy
        behaviors, parental anxiety, and parent-infant bonding.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: To evaluate the effects of the ROR intervention on the home literacy environment by comparing home literacy scores
  time frame: Between enrollment and 3 months corrected gestational age for infant
  measure: To evaluate the effects of the ROR intervention on parental stress levels as assessed by the 6-question State-Trait Anxiety Index (STAI-6)
  time frame: Between enrollment and 3 months corrected gestational age for infant
  measure: To evaluate the effects of the ROR intervention on parent-infant bonding by comparing scores on the 25-item Postpartum Bonding Questionnaire (PBQ)
  time frame: Between enrollment and 3 months corrected gestational age for infant
  measure: To complete a needs assessment for literacy interventions in the NICU population through evaluating baseline home literacy scores.
  time frame: At enrollment
  arm group label: Reach Out and Read
  arm group type: Experimental
  description: Families assigned to this group will receive Reach Out and Read education every two weeks between enrollment and when their infant reaches 36 weeks gestation.
  arm group label: Control
  arm group type: No Intervention
  description: Standard neonatal care
  intervention type: Behavioral
  intervention name: Reach Out and Read
  description: Families will be provided with a book and ROR programming from trained study team members (either the principal investigator or a research assistant, both of whom are ROR trained). ROR programming will include discussion of current reading practices, anticipatory guidance on the importance and benefits of reading, modeling of active reading, discussion of how to incorporate reading into a daily routine and answering any questions parents/caregivers may have.
  arm group label: Reach Out and Read
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 14 Days
  healthy volunteers: No
  last name: Devin McKissic
  role: Principal Investigator
  affiliation: University of Washington
  last name: Devin McKissic
  phone: (206) 300-1239
  email: devinam@uw.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Washington
  investigator full name: Devin McKissic
  investigator title: Fellow, Neonatology