<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/NCT03758794</url>
  </required_header>
  <id_info>
    <org_study_id>nld201151</org_study_id>
    <nct_id>NCT03758794</nct_id>
  </id_info>
  <brief_title>Knowledge and Attitude of Dental Interns on Child Abuse</brief_title>
  <official_title>Knowledge and Attitude of Dental Interns on Child Abuse After Implementation of Two Educational Modules: A Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      1. Knowledge and attitude of dental interns of the pediatric dental department regarding&#xD;
           child abuse recognition and reporting will be assessed 2 times before and after&#xD;
           attending one of 2 learning modules ( interactive lecture or online module ) assessment&#xD;
           through a questionnaire&#xD;
&#xD;
        2. assessment of the learning experience through a written questionnaire&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. An introduction with the aim of the study will be given to all the interns of the&#xD;
           pediatric dentistry department, Faculty of Dentistry, Cairo University during a regular&#xD;
           scheduled seminar.&#xD;
&#xD;
        2. All interns willing to join the study will be asked to sign an informed consent.&#xD;
&#xD;
        3. A pre-test questionnaire on recognition and reporting of child abuse will be given to&#xD;
           the participants&#xD;
&#xD;
        4. The participants will be randomly allocated to 2 study groups Online Group: (this group&#xD;
           will receive the educational material through an online educational module ) Lecture&#xD;
           Group: (this group will receive the educational material through an interactive lecture&#xD;
           based educational module )&#xD;
&#xD;
        5. A post-test same as the pre-test will be used to assess the change in knowledge and&#xD;
           attitude regarding child abuse recognition and reporting after the completion of the&#xD;
           assigned educational module.&#xD;
&#xD;
        6. All participants that attended both educational modules will be asked to answer a small&#xD;
           questionnaire about their perceptions regarding the learning experience.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 1, 2019</start_date>
  <completion_date type="Anticipated">May 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2019</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Questionnaire on Knowledge and Attitude of child abuse</measure>
    <time_frame>2 questionnaires each for 15 minutes before and after the learning module</time_frame>
    <description>assess the change in knowledge and attitude of dental interns regarding child abuse before and after the educational module assigned to the group same questionnaire will be given pre and post the educational module the questionnaire will include 25 multiple choice questions each question will score 4 with the total questionnaire out of 100 . the questionnaire that will score 75 or less will be considered failed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Questionnaire on Perception of the learning experience</measure>
    <time_frame>A 10 minutes written questionnaire</time_frame>
    <description>assessment of the dental interns' perception of the educational module the questionnaire will include 7 questions about how strongly or not they preferred the educational module administrated or not evaluation of the answers and comparison between both educational modules according to the % of agreement on each module each question will be analysed with comparison between the % of interns who strongly agree, agree, neutral, disagree or strongly disagree</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">138</enrollment>
  <condition>Child Abuse</condition>
  <arm_group>
    <arm_group_label>interactive lecture module</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>interactive lecture</description>
  </arm_group>
  <arm_group>
    <arm_group_label>online educational module</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>online educational using a special link</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>interactive lecture</intervention_name>
    <description>an interactive lecture will be given to a group of dental interns students on child abuse recognition and reporting</description>
    <arm_group_label>interactive lecture module</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>online education</intervention_name>
    <description>an online educational module will be sent to a group of dental interns students on child abuse recognition and reporting</description>
    <arm_group_label>online educational module</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Dental Interns enrolled in the Pediatric Dentistry and Dental Public Health&#xD;
             Department, Faculty of Dentistry, Cairo University&#xD;
&#xD;
          -  Participants of both genders&#xD;
&#xD;
          -  Graduates of any dental school in Egypt&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who refused to sign the consent&#xD;
&#xD;
          -  Participants who won't be able to have online access to the material&#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>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 25, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>November 29, 2018</last_update_submitted>
  <last_update_submitted_qc>November 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Maria Nabil Leithy Dawood</investigator_full_name>
    <investigator_title>Principal Investigator</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/NCT03758794
org study id: nld201151
nct id: NCT03758794
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
1. Knowledge and attitude of dental interns of the pediatric dental department regarding
           child abuse recognition and reporting will be assessed 2 times before and after
           attending one of 2 learning modules ( interactive lecture or online module ) assessment
           through a questionnaire

        2. assessment of the learning experience through a written questionnaire
1. An introduction with the aim of the study will be given to all the interns of the
           pediatric dentistry department, Faculty of Dentistry, Cairo University during a regular
           scheduled seminar.

        2. All interns willing to join the study will be asked to sign an informed consent.

        3. A pre-test questionnaire on recognition and reporting of child abuse will be given to
           the participants

        4. The participants will be randomly allocated to 2 study groups Online Group: (this group
           will receive the educational material through an online educational module ) Lecture
           Group: (this group will receive the educational material through an interactive lecture
           based educational module )

        5. A post-test same as the pre-test will be used to assess the change in knowledge and
           attitude regarding child abuse recognition and reporting after the completion of the
           assigned educational module.

        6. All participants that attended both educational modules will be asked to answer a small
           questionnaire about their perceptions regarding the learning experience.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Questionnaire on Knowledge and Attitude of child abuse
time frame: 2 questionnaires each for 15 minutes before and after the learning module
description: assess the change in knowledge and attitude of dental interns regarding child abuse before and after the educational module assigned to the group same questionnaire will be given pre and post the educational module the questionnaire will include 25 multiple choice questions each question will score 4 with the total questionnaire out of 100 . the questionnaire that will score 75 or less will be considered failed
measure: Questionnaire on Perception of the learning experience
time frame: A 10 minutes written questionnaire
description: assessment of the dental interns' perception of the educational module the questionnaire will include 7 questions about how strongly or not they preferred the educational module administrated or not evaluation of the answers and comparison between both educational modules according to the % of agreement on each module each question will be analysed with comparison between the % of interns who strongly agree, agree, neutral, disagree or strongly disagree
arm group label: interactive lecture module
arm group type: Active Comparator
description: interactive lecture
arm group label: online educational module
arm group type: Active Comparator
description: online educational using a special link
intervention type: Other
intervention name: interactive lecture
description: an interactive lecture will be given to a group of dental interns students on child abuse recognition and reporting
arm group label: interactive lecture module
intervention type: Other
intervention name: online education
description: an online educational module will be sent to a group of dental interns students on child abuse recognition and reporting
arm group label: online educational module
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Maria Nabil Leithy Dawood
investigator title: Principal Investigator