<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/NCT02225301</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-1243</org_study_id>
    <secondary_id>IRB-0376</secondary_id>
    <nct_id>NCT02225301</nct_id>
  </id_info>
  <brief_title>iLookOut for Child Abuse -Online Learning Module for Early Childcare Providers</brief_title>
  <acronym>iLookOut</acronym>
  <official_title>Early Childhood Practitioner's Knowledge and Attitudes Regarding Reporting Child Abuse/Neglect-iLookOut</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Milton S. Hershey Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Milton S. Hershey Medical Center</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>
      Phase 1 was a randomized control trial that used a test-retest model to evaluate the impact&#xD;
      of iLook Out for Child Abuse, an online, interactive learning module about reporting&#xD;
      suspected child abuse. Delivered via a learning management system to early childhood&#xD;
      professionals who work with infants and young children, this study assessed iLookOut's effect&#xD;
      on 1) knowledge about reporting suspected child abuse; 2) attitudes toward reporting&#xD;
      suspected child abuse; and 3) preparedness to protect children at risk.&#xD;
&#xD;
      Findings from Phase 1 were that iLookOut will improved knowledge, changed attitudes, and&#xD;
      increase self-reported preparedness of early childhood providers to report suspected child&#xD;
      abuse.&#xD;
&#xD;
      Phase 2 of this trial is an open-enrollment study that records pre-/post- data on the same&#xD;
      measurements as Phase 1, and is available for use (free of charge) for all childcare&#xD;
      providers in Pennsylvania at https://www.ilookoutforchildabuse.com.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite their daily interactions with young children, little research has been conducted into&#xD;
      early childhood professionals' (ECPs') knowledge of, and attitudes towards, reporting of&#xD;
      child abuse/neglect. This study:&#xD;
&#xD;
        1. Evaluates the effectiveness of the online learning module, iLook Out for Child Abuse,&#xD;
           created to train and inform early childhood providers about reporting suspected child&#xD;
           abuse;&#xD;
&#xD;
        2. Identifies early childhood providers' current knowledge regarding Pennsylvania law on&#xD;
           mandated reporting of suspected child abuse;&#xD;
&#xD;
        3. Explores the factors influencing early childhood providers' current knowledge and&#xD;
           attitudes;&#xD;
&#xD;
        4. Evaluates the impact of an online educational program on early childhood providers'&#xD;
           knowledge, attitudes, and patterns of decision-making regarding mandated reporting of&#xD;
           suspected child abuse;&#xD;
&#xD;
        5. To explores the factors influencing the impact of an online educational program on early&#xD;
           childhood providers' knowledge and attitudes regarding mandated reporting of suspected&#xD;
           child abuse&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 1, 2014</start_date>
  <completion_date type="Anticipated">December 31, 2026</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2026</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in knowledge regarding reporting suspected child abuse.</measure>
    <time_frame>48 months</time_frame>
    <description>Participants will complete pre- and post-intervention measures regarding reporting suspected child abuse. A sample of Phase 1 participants also repeated knowledge measures 3-6 months post-intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in attitudes regarding reporting suspected child abuse.</measure>
    <time_frame>48 months</time_frame>
    <description>Participants will complete pre- and post-intervention measures to assess attitudes regarding reporting suspected child abuse. A sample of Phase 1 participants also repeated attitudinal measures 3-6 months post-intervention.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Evaluation of online learning module.</measure>
    <time_frame>48 months</time_frame>
    <description>Participants will complete a post-intervention questionnaire evaluating various aspects of the online learning module. A sample of Phase 1 participants also repeated evaluation measures 3-6 months post-intervention.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">35000</enrollment>
  <condition>Child Abuse</condition>
  <condition>Child Neglect</condition>
  <condition>Child Maltreatment</condition>
  <arm_group>
    <arm_group_label>iLook Out for Child Abuse</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The online learning module is an interactive, multi-media, self-paced intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>iLook Out for Child Abuse</intervention_name>
    <description>The online learning module is an interactive, multi-media, self-paced intervention.</description>
    <arm_group_label>iLook Out for Child Abuse</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Paid or volunteer staff at childcare facility&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than 18 years of age&#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>Benjamin H Levi, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Penn State Milton S. Hershey Medical Center / Penn State College of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nicole Verdiglione, BS</last_name>
    <phone>717-531-8521</phone>
    <phone_ext>283-765</phone_ext>
    <email>nverdiglione@hmc.psu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Benjamin H Levi, MD PhD</last_name>
    <phone>717-531-8778</phone>
    <email>BHLEVI@psu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Penn State Milton S. Hershey Medical Center / Penn State College of Medicine</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicole Verdiglione, BA</last_name>
      <phone>717-531-8521</phone>
      <phone_ext>283-765</phone_ext>
      <email>nverdiglione@pennstatehealth.psu.edu</email>
    </contact>
    <contact_backup>
      <last_name>Benjamin H Levi, MD PhD</last_name>
      <phone>717-531-8521</phone>
      <email>BHLevi@psu.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Benjamin H Levi, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.ilookoutforchildabuse.com</url>
    <description>Website for iLookOut learning module</description>
  </link>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>December 28, 2022</last_update_submitted>
  <last_update_submitted_qc>December 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Milton S. Hershey Medical Center</investigator_affiliation>
    <investigator_full_name>Benjamin H. Levi</investigator_full_name>
    <investigator_title>Professor of Humanities &amp; Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Child maltreatment</keyword>
  <keyword>Child Care</keyword>
  <keyword>Knowledge</keyword>
  <keyword>Attitude</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Aggregate data will be available after the study's primary outcomes have been fully analyzed and published.</ipd_description>
  </patient_data>
  <!-- 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/NCT02225301
org study id: IRB-1243
secondary id: IRB-0376
nct id: NCT02225301
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Phase 1 was a randomized control trial that used a test-retest model to evaluate the impact
      of iLook Out for Child Abuse, an online, interactive learning module about reporting
      suspected child abuse. Delivered via a learning management system to early childhood
      professionals who work with infants and young children, this study assessed iLookOut's effect
      on 1) knowledge about reporting suspected child abuse; 2) attitudes toward reporting
      suspected child abuse; and 3) preparedness to protect children at risk.

      Findings from Phase 1 were that iLookOut will improved knowledge, changed attitudes, and
      increase self-reported preparedness of early childhood providers to report suspected child
      abuse.

      Phase 2 of this trial is an open-enrollment study that records pre-/post- data on the same
      measurements as Phase 1, and is available for use (free of charge) for all childcare
      providers in Pennsylvania at https://www.ilookoutforchildabuse.com.
Despite their daily interactions with young children, little research has been conducted into
      early childhood professionals' (ECPs') knowledge of, and attitudes towards, reporting of
      child abuse/neglect. This study:

        1. Evaluates the effectiveness of the online learning module, iLook Out for Child Abuse,
           created to train and inform early childhood providers about reporting suspected child
           abuse;

        2. Identifies early childhood providers' current knowledge regarding Pennsylvania law on
           mandated reporting of suspected child abuse;

        3. Explores the factors influencing early childhood providers' current knowledge and
           attitudes;

        4. Evaluates the impact of an online educational program on early childhood providers'
           knowledge, attitudes, and patterns of decision-making regarding mandated reporting of
           suspected child abuse;

        5. To explores the factors influencing the impact of an online educational program on early
           childhood providers' knowledge and attitudes regarding mandated reporting of suspected
           child abuse
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in knowledge regarding reporting suspected child abuse.
time frame: 48 months
description: Participants will complete pre- and post-intervention measures regarding reporting suspected child abuse. A sample of Phase 1 participants also repeated knowledge measures 3-6 months post-intervention.
measure: Change in attitudes regarding reporting suspected child abuse.
time frame: 48 months
description: Participants will complete pre- and post-intervention measures to assess attitudes regarding reporting suspected child abuse. A sample of Phase 1 participants also repeated attitudinal measures 3-6 months post-intervention.
measure: Evaluation of online learning module.
time frame: 48 months
description: Participants will complete a post-intervention questionnaire evaluating various aspects of the online learning module. A sample of Phase 1 participants also repeated evaluation measures 3-6 months post-intervention.
arm group label: iLook Out for Child Abuse
arm group type: Experimental
description: The online learning module is an interactive, multi-media, self-paced intervention.
intervention type: Other
intervention name: iLook Out for Child Abuse
description: The online learning module is an interactive, multi-media, self-paced intervention.
arm group label: iLook Out for Child Abuse
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Benjamin H Levi, MD PhD
role: Principal Investigator
affiliation: Penn State Milton S. Hershey Medical Center / Penn State College of Medicine
last name: Nicole Verdiglione, BS
phone: 717-531-8521
phone ext: 283-765
email: nverdiglione@hmc.psu.edu
last name: Benjamin H Levi, MD PhD
phone: 717-531-8778
email: BHLEVI@psu.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
url: https://www.ilookoutforchildabuse.com
description: Website for iLookOut learning module
responsible party type: Principal Investigator
investigator affiliation: Milton S. Hershey Medical Center
investigator full name: Benjamin H. Levi
investigator title: Professor of Humanities & Pediatrics
sharing ipd: No
ipd description: Aggregate data will be available after the study's primary outcomes have been fully analyzed and published.