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/NCT05986565</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00008481</org_study_id>
      <nct_id>NCT05986565</nct_id>
    </id_info>
    <brief_title>Study of the Families Moving Forward Website Behavioral Intervention for Teachers of Students With Fetal Alcohol Spectrum Disorder</brief_title>
    <official_title>Pilot Trial of the FMF Connect Teacher Companion Website</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Rochester</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Rochester</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 purpose of this study is to find out if the FMF Connect Teacher Companion website is&#xD;
        acceptable and usable by teachers. The FMF Connect Teacher Companion website is a website for&#xD;
        teachers adapted from the Families Moving Forward (FMF) Program. The FMF Program is an&#xD;
        evidence-based intervention for caregivers of children with FASD. The study will determine if&#xD;
        the a web page intervention is feasible and acceptable by looking at enrollment and retention&#xD;
        of study subjects and acceptability of assessments.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 24, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>mean knowledge about FASD</measure>
      <time_frame>6 weeks</time_frame>
      <description>Teacher FASD knowledge will be measured using the &quot;Fetal Alcohol Spectrum Disorder (FASD) Knowledge&quot; survey. The survey scores range from 0-33 with higher scores indicating more knowledge about FASD.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>mean behavioral attributions</measure>
      <time_frame>6 weeks</time_frame>
      <description>Attributions are measured by the Reasons for Children's Behavior (RCB) across seven subscales of behavior and willful or ability-based attributions. Teachers are assessed for whether they agree or disagree with 30 different statements about FASD student behaviors. The survey score ranges from 30-180 with higher scores indicating more adaptive attributions of the students behavior.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>mean self-efficacy in teaching.</measure>
      <time_frame>6 weeks</time_frame>
      <description>The Teacher Self Efficacy Scale (TSES) measures teachers' sense of self-efficacy in teaching and supporting students in the classroom. The tool ranges from 10 to 60 with higher scores indicating more self-efficacy.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>mean acceptability of study procedures</measure>
      <time_frame>6 weeks</time_frame>
      <description>The Study Experiences Survey (SES) was developed for this study and assesses participants' experiences with the study procedures. The survey scores ranges 10-60 with higher scores indicating more acceptability of the study.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>mean functionality, usefulness and helpfulness of the website</measure>
      <time_frame>6 weeks</time_frame>
      <description>The Mobile Application Rating Scale - User Version (uMARS) assesses functionality, usefulness, and helpfulness of technology and information. It is originally used for apps but has been adapted for a website. The scores range from 26-130 with higher scores indicating better functionality, more usefulness and helpfulness.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Fetal Alcohol Spectrum Disorders</condition>
    <arm_group>
      <arm_group_label>Website treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This arm will receive access to the FMF teacher adapted website.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>delayed treatment control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This arm will get the same intervention as the experimental arm delayed by 6 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Families Moving Forward (FMF) Teacher adapted training</intervention_name>
      <description>The FMF Connect Teacher Companion website is designed to offer teachers evidence-based education about FASD and strategies to support students with FASD. It is adapted from the FMF Program and FMF Connect, evidence based interventions to support caregivers of children with FASD. The FMF Program and FMF Connect aim to improve caregivers' efficacy and satisfaction as a parent, efficacy, attributions for their child's behavior, and the parent-child relationship.</description>
      <arm_group_label>Website treatment</arm_group_label>
      <arm_group_label>delayed treatment control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Be an educational professional currently actively employed in a school setting in the&#xD;
               United States&#xD;
  &#xD;
            -  Be above the age of 18 years old&#xD;
  &#xD;
            -  Have direct, consistent contact with a student with a diagnosed fetal alcohol spectrum&#xD;
               disorder (FASD) or confirmed prenatal alcohol exposure (PAE) between the ages of 5-12,&#xD;
               (i.e. grades K to 5) in a special or general education classroom&#xD;
  &#xD;
            -  Have reliable access to the Internet&#xD;
  &#xD;
            -  Be able to consent for themselves&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  They are unable to read English&#xD;
  &#xD;
            -  They do not have direct, consistent contact with a student with a diagnosed FASD&#xD;
               between ages 5-12 (e.g., substitute teacher, principal)&#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_contact>
      <last_name>Carson Kautz-Turnbull, MA</last_name>
      <phone>5852752991</phone>
      <email>carson_kautz@urmc.rochester.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Rochester Medical Center</name>
        <address>
          <city>Rochester</city>
          <state>New York</state>
          <zip>14642</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Carson Kautz-Turnbull, MA</last_name>
        <email>carson_kautz@urmc.rochester.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Rochester</investigator_affiliation>
      <investigator_full_name>Christie Petrenko</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fetal Alcohol Spectrum Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05986565
  org study id: STUDY00008481
  nct id: NCT05986565
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to find out if the FMF Connect Teacher Companion website is
        acceptable and usable by teachers. The FMF Connect Teacher Companion website is a website for
        teachers adapted from the Families Moving Forward (FMF) Program. The FMF Program is an
        evidence-based intervention for caregivers of children with FASD. The study will determine if
        the a web page intervention is feasible and acceptable by looking at enrollment and retention
        of study subjects and acceptability of assessments.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: mean knowledge about FASD
  time frame: 6 weeks
  description: Teacher FASD knowledge will be measured using the "Fetal Alcohol Spectrum Disorder (FASD) Knowledge" survey. The survey scores range from 0-33 with higher scores indicating more knowledge about FASD.
  measure: mean behavioral attributions
  time frame: 6 weeks
  description: Attributions are measured by the Reasons for Children's Behavior (RCB) across seven subscales of behavior and willful or ability-based attributions. Teachers are assessed for whether they agree or disagree with 30 different statements about FASD student behaviors. The survey score ranges from 30-180 with higher scores indicating more adaptive attributions of the students behavior.
  measure: mean self-efficacy in teaching.
  time frame: 6 weeks
  description: The Teacher Self Efficacy Scale (TSES) measures teachers' sense of self-efficacy in teaching and supporting students in the classroom. The tool ranges from 10 to 60 with higher scores indicating more self-efficacy.
  measure: mean acceptability of study procedures
  time frame: 6 weeks
  description: The Study Experiences Survey (SES) was developed for this study and assesses participants' experiences with the study procedures. The survey scores ranges 10-60 with higher scores indicating more acceptability of the study.
  measure: mean functionality, usefulness and helpfulness of the website
  time frame: 6 weeks
  description: The Mobile Application Rating Scale - User Version (uMARS) assesses functionality, usefulness, and helpfulness of technology and information. It is originally used for apps but has been adapted for a website. The scores range from 26-130 with higher scores indicating better functionality, more usefulness and helpfulness.
  arm group label: Website treatment
  arm group type: Experimental
  description: This arm will receive access to the FMF teacher adapted website.
  arm group label: delayed treatment control
  arm group type: Active Comparator
  description: This arm will get the same intervention as the experimental arm delayed by 6 weeks.
  intervention type: Behavioral
  intervention name: Families Moving Forward (FMF) Teacher adapted training
  description: The FMF Connect Teacher Companion website is designed to offer teachers evidence-based education about FASD and strategies to support students with FASD. It is adapted from the FMF Program and FMF Connect, evidence based interventions to support caregivers of children with FASD. The FMF Program and FMF Connect aim to improve caregivers' efficacy and satisfaction as a parent, efficacy, attributions for their child's behavior, and the parent-child relationship.
  arm group label: Website treatment
  arm group label: delayed treatment control
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Carson Kautz-Turnbull, MA
  phone: 5852752991
  email: carson_kautz@urmc.rochester.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Rochester
  investigator full name: Christie Petrenko
  investigator title: Professor
  mesh term: Fetal Alcohol Spectrum Disorders
  sharing ipd: No