<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/NCT03766906</url>
  </required_header>
  <id_info>
    <org_study_id>MD013619-01</org_study_id>
    <secondary_id>R44MD013619</secondary_id>
    <nct_id>NCT03766906</nct_id>
  </id_info>
  <brief_title>STEM (Science, Technology, Engineering &amp; Math) Familia Talk</brief_title>
  <official_title>STEM Familia Talk: A Bilingual Language Acquisition Smart Speaker App to Improve Academic Vocabulary, Engagement and Long-term Education and Health Outcomes for Latino Students and Their Families</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Research Behavioral Intervention Strategies, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Minority Health and Health Disparities (NIMHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Oregon Research Behavioral Intervention Strategies, Inc.</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>
      After development of the Talk Stem Familia (TSF) smart-speaker application prototype, the&#xD;
      study will evaluate the prototype's efficacy in a within-subjects pre-post design study. The&#xD;
      sample will contain 50 parent-student/child dyads who will use the Alexa skill app for 6&#xD;
      weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will receive an Echo Dot device enabled with the application prototype using a&#xD;
      research Amazon account created for each dyad. The Echo Dot devices will be preconfigured by&#xD;
      project staff onto research Amazon accounts. Parents will come to one of several orientation&#xD;
      sessions to obtain their device and set-up instructions; staff will provide follow-up phone&#xD;
      support as needed. Usage data will show how much the device is used by each dyad. To ensure&#xD;
      exposure to TSF, parents will be asked to engage at least 3 times per week; project staff&#xD;
      will prompt parents bi-weekly (via text, email, device notification, phone) during the 6-week&#xD;
      intervention to encourage usage and provide needed technical support.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">July 30, 2019</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>
    <intervention_model_description>One-arm, single-group, feasibility study with parent/student dyads.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Student Academic Vocabulary Knowledge in English</measure>
    <time_frame>Baseline (pretest) and 6 weeks (posttest)</time_frame>
    <description>The Student Academic Vocabulary Knowledge in English measure includes 18 multiple choice questions on the 18 words taught in the TSF app. The student chooses the correct word meaning from among four (4) possible responses. Students receive one point for each word correctly identified and points are summed across the 18 items. Scores can range from 0-18 and a higher score indicates greater vocabulary knowledge.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parent Academic Vocabulary Knowledge in Spanish</measure>
    <time_frame>Baseline (pretest) and 6 weeks (posttest)</time_frame>
    <description>The Parent Academic Vocabulary Knowledge in Spanish measure includes 18 multiple choice questions on the 18 words taught in the TSF app. The parent chooses the correct word meaning from among four (4) possible responses. Parents receive one point for each word correctly identified and points are summed across the 18 items. Scores can range from 0-18 and a higher score indicates greater vocabulary knowledge.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Student Academic Vocabulary Usage in English</measure>
    <time_frame>Baseline (pretest) and 6 weeks (posttest)</time_frame>
    <description>The Student Academic Vocabulary Usage in English measure includes 18 true/false questions testing student knowledge of correct usage of the 18 academic vocabulary words taught in the TSF app.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parent Academic Vocabulary Usage in Spanish</measure>
    <time_frame>Baseline (pretest) and 6 weeks (posttest)</time_frame>
    <description>The Parent Academic Vocabulary Usage in Spanish measure includes 18 true/false questions testing student knowledge of correct usage of the 18 academic vocabulary words taught in the TSF app.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Student Engagement Instrument</measure>
    <time_frame>Baseline (pretest) and 6 weeks (posttest)</time_frame>
    <description>The Student Engagement Instrument (SEI; Betts, Appleton, Reschly, et al., 2010) consists of three subscales (future aspirations and goals, 5 items, r = .80, family support for learning, 6 items, r = .79, and control and relevance of school work, 9 items, r = 70). The SEI scale for each item ranges from 1-&quot;Strongly disagree&quot; to 5- &quot;Strongly agree&quot; with 5 indicating greater self-efficacy (more positive). A sum score was computed for each subscale. For future aspirations the scores can range from 5 to 25 and a higher score indicates a more positive outcome; greater self-efficacy for future aspirations. For family support for learning the score can range from 6 to 30 and a higher scores indicates a more positive outcome; greater self-efficacy for family support for learning. For control and relevance of school work the scores can range from 9 to 45 and a greater score indicates a more positive outcome; greater self-efficacy for control and relevance of school work.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Efficacy to Influence School-related Performance Subscale of the Parental Self-Efficacy Scale</measure>
    <time_frame>Baseline (pretest) and 6 weeks (posttest)</time_frame>
    <description>The Efficacy to Influence School-related Performance subscale of the Parental Self-Efficacy Scale (PSES; Bandura, et al., 2001) (completed in Spanish) to measure useful factors that reflect parents' perceptions of whether they can influence their child's academic performance. The PSES consists of 8 items on a 9-point scale ranging from 1 = &quot;nothing&quot; to 9 = &quot;a great deal&quot; . The measure has an internal reliability of .87. A mean composite score was computed and the scores can range from 1 to 9 with a higher score indicating a more positive outcome; greater levels of self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Student Academic Language Learning Behaviors</measure>
    <time_frame>Baseline (pretest) and 6 weeks (posttest)</time_frame>
    <description>The Student Academic Language Learning Behaviors measure includes 11 items asking students to estimate the frequency of discrete learning behaviors such as saying &quot;scientific&quot; words out loud in English and using &quot;scientific&quot; words in sentences. The measure uses a 4-point scale of frequency with 1 being &quot;Not at all&quot; and 4 being &quot; 3-4 times a week.&quot; A sum score for the 11 items was computed and the scores could range from 11 to 44. Higher scores indicate a more positive outcome; greater frequency of behaviors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent Academic Enabling Behaviors</measure>
    <time_frame>Baseline (pretest) and 6 weeks (posttest)</time_frame>
    <description>The Parent Academic Enabling Behaviors measure includes 13 items asking parents to estimate the frequency of their discrete academic enabling behaviors, such as helping their child learn the meaning of &quot;scientific&quot; words and using &quot;scientific&quot; words in a conversation with their child. The measure uses a 4-point scale of frequency with 1 being &quot;Not at all&quot; and 4 being &quot; 3-4 times a week.&quot; A sum score including all 13 items was computed and can range between 13 and 52. Higher scores indicate a more positive outcome; greater frequency of behaviors.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Language Development</condition>
  <arm_group>
    <arm_group_label>Talk STEM Familia App</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will test the feasibility of the Talk STEM Familia app to improve English language acquisition and family engagement and promote long-term educational and health outcomes among first- and second-generation Latino families.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Talk STEM Familia app</intervention_name>
    <description>The Talk STEM Familia app will be used to improve access to sound instruction in scientific academic vocabulary through the development of a technology-enhanced, culturally responsive smart-speaker tool that engages Latino families in culturally responsive academic language acquisition and practice in the home setting.</description>
    <arm_group_label>Talk STEM Familia App</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Latino parents and their children who are students in grades 3 through 6.&#xD;
&#xD;
          -  Parents have Spanish as primary home language.&#xD;
&#xD;
          -  Family has wi-fi in the home.&#xD;
&#xD;
          -  No age limits for parents. Their child must be in grades 3 through 6.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parents and their children who are students in grade levels below grade 3 or above&#xD;
             grade 6.&#xD;
&#xD;
          -  Parents do not have Spanish as primary home language.&#xD;
&#xD;
          -  Family does not have wi-fi in the home.&#xD;
&#xD;
          -  Children younger than 8 (or in grade levels below grade 3).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David R. Smith, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Oregon Research Behavioral Intervention Strategies, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oregon Research Behavioral Intervention Strategies, Inc.</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <results_first_submitted>August 4, 2022</results_first_submitted>
  <results_first_submitted_qc>December 1, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 23, 2022</results_first_posted>
  <last_update_submitted>February 6, 2023</last_update_submitted>
  <last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT03766906/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT03766906/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Talk STEM Familia App</title>
          <description>This arm will test the feasibility of the Talk STEM Familia app to improve English language acquisition and family engagement and promote long-term educational and health outcomes among first- and second-generation Latino families.&#xD;
Talk STEM Familia app: The Talk STEM Familia app will be used to improve access to sound instruction in scientific academic vocabulary through the development of a technology-enhanced, culturally responsive smart-speaker tool that engages Latino families in culturally responsive academic language acquisition and practice in the home setting.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50">50 dyads = 100 unique participants.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="44">44 dyads = 88 unique participants.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Latinx, English-learner, parent/student dyads.</population>
      <group_list>
        <group group_id="B1">
          <title>Talk STEM Familia App</title>
          <description>This arm will test the feasibility of the Talk STEM Familia app to improve English language acquisition and family engagement and promote long-term educational and health outcomes among first- and second-generation Latino families.&#xD;
Talk STEM Familia app: The Talk STEM Familia app will be used to improve access to sound instruction in scientific academic vocabulary through the development of a technology-enhanced, culturally responsive smart-speaker tool that engages Latino families in culturally responsive academic language acquisition and practice in the home setting.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Parent participants reported age in years on demographic survey. Student participants had to be in 3rd -6th grade to be eligible to participate. Age was extrapolated from grade-level.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Baseline participants were 50 parent-student dyads, 50 parents and 50 students. Parent and student data were analyzed separately.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Student participants</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Parent participants</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <population>Race/ethnicity information was only collected from parent participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Parent race/ethnicity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Euro American/Caucasian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>African American/Black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American Indian or Alaskan Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Prefer not to disclose</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Student Academic Vocabulary Knowledge in English</title>
        <description>The Student Academic Vocabulary Knowledge in English measure includes 18 multiple choice questions on the 18 words taught in the TSF app. The student chooses the correct word meaning from among four (4) possible responses. Students receive one point for each word correctly identified and points are summed across the 18 items. Scores can range from 0-18 and a higher score indicates greater vocabulary knowledge.</description>
        <time_frame>Baseline (pretest) and 6 weeks (posttest)</time_frame>
        <population>Latinx, English-learner students.</population>
        <group_list>
          <group group_id="O1">
            <title>Talk STEM Familia App</title>
            <description>This arm will test the feasibility of the Talk STEM Familia app to improve English language acquisition and family engagement and promote long-term educational and health outcomes among first- and second-generation Latino families.&#xD;
Talk STEM Familia app: The Talk STEM Familia app will be used to improve access to sound instruction in scientific academic vocabulary through the development of a technology-enhanced, culturally responsive smart-speaker tool that engages Latino families in culturally responsive academic language acquisition and practice in the home setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Student Academic Vocabulary Knowledge in English</title>
          <description>The Student Academic Vocabulary Knowledge in English measure includes 18 multiple choice questions on the 18 words taught in the TSF app. The student chooses the correct word meaning from among four (4) possible responses. Students receive one point for each word correctly identified and points are summed across the 18 items. Scores can range from 0-18 and a higher score indicates greater vocabulary knowledge.</description>
          <population>Latinx, English-learner students.</population>
          <units>Number of correct responses</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pretest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.36" spread="3.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Posttest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.39" spread="3.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.003</p_value>
            <method>t-test, 2 sided</method>
            <method_desc>Within subjects paired t-tests.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>2.03</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Investigators tested whether pretest to posttest change was significantly greater than 0 at P &lt; 0.05.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Parent Academic Vocabulary Knowledge in Spanish</title>
        <description>The Parent Academic Vocabulary Knowledge in Spanish measure includes 18 multiple choice questions on the 18 words taught in the TSF app. The parent chooses the correct word meaning from among four (4) possible responses. Parents receive one point for each word correctly identified and points are summed across the 18 items. Scores can range from 0-18 and a higher score indicates greater vocabulary knowledge.</description>
        <time_frame>Baseline (pretest) and 6 weeks (posttest)</time_frame>
        <population>Latinx English learner parents</population>
        <group_list>
          <group group_id="O1">
            <title>Talk STEM Familia App</title>
            <description>This arm will test the feasibility of the Talk STEM Familia app to improve English language acquisition and family engagement and promote long-term educational and health outcomes among first- and second-generation Latino families.&#xD;
Talk STEM Familia app: The Talk STEM Familia app will be used to improve access to sound instruction in scientific academic vocabulary through the development of a technology-enhanced, culturally responsive smart-speaker tool that engages Latino families in culturally responsive academic language acquisition and practice in the home setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Parent Academic Vocabulary Knowledge in Spanish</title>
          <description>The Parent Academic Vocabulary Knowledge in Spanish measure includes 18 multiple choice questions on the 18 words taught in the TSF app. The parent chooses the correct word meaning from among four (4) possible responses. Parents receive one point for each word correctly identified and points are summed across the 18 items. Scores can range from 0-18 and a higher score indicates greater vocabulary knowledge.</description>
          <population>Latinx English learner parents</population>
          <units>Number of correct responses</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pretest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.40" spread="3.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Posttest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.58" spread="3.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.022</p_value>
            <method>t-test, 2 sided</method>
            <method_desc>Within subjects paired t-tests.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.18</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Investigators tested whether pre-test to post-test change was significantly greater than zero at P&lt;0.05.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Student Academic Vocabulary Usage in English</title>
        <description>The Student Academic Vocabulary Usage in English measure includes 18 true/false questions testing student knowledge of correct usage of the 18 academic vocabulary words taught in the TSF app.</description>
        <time_frame>Baseline (pretest) and 6 weeks (posttest)</time_frame>
        <population>Latinx, English-learner students.</population>
        <group_list>
          <group group_id="O1">
            <title>Talk STEM Familia App</title>
            <description>This arm will test the feasibility of the Talk STEM Familia app to improve English language acquisition and family engagement and promote long-term educational and health outcomes among first- and second-generation Latino families.&#xD;
Talk STEM Familia app: The Talk STEM Familia app will be used to improve access to sound instruction in scientific academic vocabulary through the development of a technology-enhanced, culturally responsive smart-speaker tool that engages Latino families in culturally responsive academic language acquisition and practice in the home setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Student Academic Vocabulary Usage in English</title>
          <description>The Student Academic Vocabulary Usage in English measure includes 18 true/false questions testing student knowledge of correct usage of the 18 academic vocabulary words taught in the TSF app.</description>
          <population>Latinx, English-learner students.</population>
          <units>percentage of correct responses</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.14" spread="3.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.48" spread="2.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.016</p_value>
            <method>t-test, 2 sided</method>
            <method_desc>Within subjects paired t-tests</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.34</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Investigators tested whether pre-test to post-test change was significantly greater than 0 at P&lt;0.05.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Parent Academic Vocabulary Usage in Spanish</title>
        <description>The Parent Academic Vocabulary Usage in Spanish measure includes 18 true/false questions testing student knowledge of correct usage of the 18 academic vocabulary words taught in the TSF app.</description>
        <time_frame>Baseline (pretest) and 6 weeks (posttest)</time_frame>
        <population>Latinx, English-learner parents.</population>
        <group_list>
          <group group_id="O1">
            <title>Talk STEM Familia App</title>
            <description>This arm will test the feasibility of the Talk STEM Familia app to improve English language acquisition and family engagement and promote long-term educational and health outcomes among first- and second-generation Latino families.&#xD;
Talk STEM Familia app: The Talk STEM Familia app will be used to improve access to sound instruction in scientific academic vocabulary through the development of a technology-enhanced, culturally responsive smart-speaker tool that engages Latino families in culturally responsive academic language acquisition and practice in the home setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Parent Academic Vocabulary Usage in Spanish</title>
          <description>The Parent Academic Vocabulary Usage in Spanish measure includes 18 true/false questions testing student knowledge of correct usage of the 18 academic vocabulary words taught in the TSF app.</description>
          <population>Latinx, English-learner parents.</population>
          <units>percentage of correct responses</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.08" spread="2.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.03" spread="1.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.002</p_value>
            <method>t-test, 2 sided</method>
            <method_desc>Within subjects paired t-tests.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.95</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Investigators tested whether pre-test to post-test change was significantly greater than 0 at P&lt;0.05.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Student Engagement Instrument</title>
        <description>The Student Engagement Instrument (SEI; Betts, Appleton, Reschly, et al., 2010) consists of three subscales (future aspirations and goals, 5 items, r = .80, family support for learning, 6 items, r = .79, and control and relevance of school work, 9 items, r = 70). The SEI scale for each item ranges from 1-&quot;Strongly disagree&quot; to 5- &quot;Strongly agree&quot; with 5 indicating greater self-efficacy (more positive). A sum score was computed for each subscale. For future aspirations the scores can range from 5 to 25 and a higher score indicates a more positive outcome; greater self-efficacy for future aspirations. For family support for learning the score can range from 6 to 30 and a higher scores indicates a more positive outcome; greater self-efficacy for family support for learning. For control and relevance of school work the scores can range from 9 to 45 and a greater score indicates a more positive outcome; greater self-efficacy for control and relevance of school work.</description>
        <time_frame>Baseline (pretest) and 6 weeks (posttest)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Talk STEM Familia App</title>
            <description>This arm will test the feasibility of the Talk STEM Familia app to improve English language acquisition and family engagement and promote long-term educational and health outcomes among first- and second-generation Latino families.&#xD;
Talk STEM Familia app: The Talk STEM Familia app will be used to improve access to sound instruction in scientific academic vocabulary through the development of a technology-enhanced, culturally responsive smart-speaker tool that engages Latino families in culturally responsive academic language acquisition and practice in the home setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Student Engagement Instrument</title>
          <description>The Student Engagement Instrument (SEI; Betts, Appleton, Reschly, et al., 2010) consists of three subscales (future aspirations and goals, 5 items, r = .80, family support for learning, 6 items, r = .79, and control and relevance of school work, 9 items, r = 70). The SEI scale for each item ranges from 1-&quot;Strongly disagree&quot; to 5- &quot;Strongly agree&quot; with 5 indicating greater self-efficacy (more positive). A sum score was computed for each subscale. For future aspirations the scores can range from 5 to 25 and a higher score indicates a more positive outcome; greater self-efficacy for future aspirations. For family support for learning the score can range from 6 to 30 and a higher scores indicates a more positive outcome; greater self-efficacy for family support for learning. For control and relevance of school work the scores can range from 9 to 45 and a greater score indicates a more positive outcome; greater self-efficacy for control and relevance of school work.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Relevance to schoolwork pre-test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.68" spread="5.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relevance to schoolwork post-test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.06" spread="5.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Future aspirations pre-test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.78" spread="2.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Future aspirations post-test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.73" spread="2.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Family support pre-test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.18" spread="3.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Family support post-test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.11" spread="3.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The statistical analyses for the Student Self-Efficacy, in terms of type of statistical test, method, and the comments which we state within-subjects paired t-tests, are the same for each of the three subscales that make up Student Self-Efficacy (i.e., Relevance to schoolwork, Future aspirations, and Family support).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.626</p_value>
            <method>t-test, 2 sided</method>
            <method_desc>Within subjects paired t-tests.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.38</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Investigators tested whether pre-test to post-test change was significantly greater than 0 at P&lt;0.05.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The statistical analyses for the Student Self-Efficacy, in terms of type of statistical test, method, and the comments which we state within-subjects paired t-tests, are the same for each of the three subscales that make up Student Self-Efficacy (i.e., Relevance to schoolwork, Future aspirations, and Family support).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.909</p_value>
            <method>t-test, 2 sided</method>
            <method_desc>Investigators tested whether pre-test to post-test change was significantly greater than 0 at P&lt;0.05.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.05</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The statistical analyses for the Student Self-Efficacy, in terms of type of statistical test, method, and the comments which we state within-subjects paired t-tests, are the same for each of the three subscales that make up Student Self-Efficacy (i.e., Relevance to schoolwork, Future aspirations, and Family support).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.905</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.07</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Investigators tested whether pre-test to post-test change was significantly greater than 0 at P&lt;0.05.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Efficacy to Influence School-related Performance Subscale of the Parental Self-Efficacy Scale</title>
        <description>The Efficacy to Influence School-related Performance subscale of the Parental Self-Efficacy Scale (PSES; Bandura, et al., 2001) (completed in Spanish) to measure useful factors that reflect parents' perceptions of whether they can influence their child's academic performance. The PSES consists of 8 items on a 9-point scale ranging from 1 = &quot;nothing&quot; to 9 = &quot;a great deal&quot; . The measure has an internal reliability of .87. A mean composite score was computed and the scores can range from 1 to 9 with a higher score indicating a more positive outcome; greater levels of self-efficacy.</description>
        <time_frame>Baseline (pretest) and 6 weeks (posttest)</time_frame>
        <population>Latinx, English-learner parents.</population>
        <group_list>
          <group group_id="O1">
            <title>Talk STEM Familia App</title>
            <description>This arm will test the feasibility of the Talk STEM Familia app to improve English language acquisition and family engagement and promote long-term educational and health outcomes among first- and second-generation Latino families.&#xD;
Talk STEM Familia app: The Talk STEM Familia app will be used to improve access to sound instruction in scientific academic vocabulary through the development of a technology-enhanced, culturally responsive smart-speaker tool that engages Latino families in culturally responsive academic language acquisition and practice in the home setting.</description>
          </group>
        </group_list>
        <measure>
          <title>The Efficacy to Influence School-related Performance Subscale of the Parental Self-Efficacy Scale</title>
          <description>The Efficacy to Influence School-related Performance subscale of the Parental Self-Efficacy Scale (PSES; Bandura, et al., 2001) (completed in Spanish) to measure useful factors that reflect parents' perceptions of whether they can influence their child's academic performance. The PSES consists of 8 items on a 9-point scale ranging from 1 = &quot;nothing&quot; to 9 = &quot;a great deal&quot; . The measure has an internal reliability of .87. A mean composite score was computed and the scores can range from 1 to 9 with a higher score indicating a more positive outcome; greater levels of self-efficacy.</description>
          <population>Latinx, English-learner parents.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Parental Self-Efficacy at pre-test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.26" spread="1.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Parental Self-Efficacy at post-test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.62" spread="1.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.054</p_value>
            <method>t-test, 2 sided</method>
            <method_desc>Within subjects paired t-tests.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.36</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Investigators tested whether pre-test to post-test change was significantly greater than 0 at P&lt;0.05.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Student Academic Language Learning Behaviors</title>
        <description>The Student Academic Language Learning Behaviors measure includes 11 items asking students to estimate the frequency of discrete learning behaviors such as saying &quot;scientific&quot; words out loud in English and using &quot;scientific&quot; words in sentences. The measure uses a 4-point scale of frequency with 1 being &quot;Not at all&quot; and 4 being &quot; 3-4 times a week.&quot; A sum score for the 11 items was computed and the scores could range from 11 to 44. Higher scores indicate a more positive outcome; greater frequency of behaviors.</description>
        <time_frame>Baseline (pretest) and 6 weeks (posttest)</time_frame>
        <population>Latinx, English-learner students.</population>
        <group_list>
          <group group_id="O1">
            <title>Talk STEM Familia App</title>
            <description>This arm will test the feasibility of the Talk STEM Familia app to improve English language acquisition and family engagement and promote long-term educational and health outcomes among first- and second-generation Latino families.&#xD;
Talk STEM Familia app: The Talk STEM Familia app will be used to improve access to sound instruction in scientific academic vocabulary through the development of a technology-enhanced, culturally responsive smart-speaker tool that engages Latino families in culturally responsive academic language acquisition and practice in the home setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Student Academic Language Learning Behaviors</title>
          <description>The Student Academic Language Learning Behaviors measure includes 11 items asking students to estimate the frequency of discrete learning behaviors such as saying &quot;scientific&quot; words out loud in English and using &quot;scientific&quot; words in sentences. The measure uses a 4-point scale of frequency with 1 being &quot;Not at all&quot; and 4 being &quot; 3-4 times a week.&quot; A sum score for the 11 items was computed and the scores could range from 11 to 44. Higher scores indicate a more positive outcome; greater frequency of behaviors.</description>
          <population>Latinx, English-learner students.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Student academic language learning behavior at pre-test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.53" spread="7.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Student academic language learning behavior at post-test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.01" spread="8.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>t-test, 2 sided</method>
            <method_desc>Within subjects paired t-tests.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>3.48</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Investigators tested whether pre-test to post-test change was significantly greater than 0 at P&lt;0.05.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parent Academic Enabling Behaviors</title>
        <description>The Parent Academic Enabling Behaviors measure includes 13 items asking parents to estimate the frequency of their discrete academic enabling behaviors, such as helping their child learn the meaning of &quot;scientific&quot; words and using &quot;scientific&quot; words in a conversation with their child. The measure uses a 4-point scale of frequency with 1 being &quot;Not at all&quot; and 4 being &quot; 3-4 times a week.&quot; A sum score including all 13 items was computed and can range between 13 and 52. Higher scores indicate a more positive outcome; greater frequency of behaviors.</description>
        <time_frame>Baseline (pretest) and 6 weeks (posttest)</time_frame>
        <population>Latinx, English-learner students.</population>
        <group_list>
          <group group_id="O1">
            <title>Talk STEM Familia App</title>
            <description>This arm will test the feasibility of the Talk STEM Familia app to improve English language acquisition and family engagement and promote long-term educational and health outcomes among first- and second-generation Latino families.&#xD;
Talk STEM Familia app: The Talk STEM Familia app will be used to improve access to sound instruction in scientific academic vocabulary through the development of a technology-enhanced, culturally responsive smart-speaker tool that engages Latino families in culturally responsive academic language acquisition and practice in the home setting.</description>
          </group>
        </group_list>
        <measure>
          <title>Parent Academic Enabling Behaviors</title>
          <description>The Parent Academic Enabling Behaviors measure includes 13 items asking parents to estimate the frequency of their discrete academic enabling behaviors, such as helping their child learn the meaning of &quot;scientific&quot; words and using &quot;scientific&quot; words in a conversation with their child. The measure uses a 4-point scale of frequency with 1 being &quot;Not at all&quot; and 4 being &quot; 3-4 times a week.&quot; A sum score including all 13 items was computed and can range between 13 and 52. Higher scores indicate a more positive outcome; greater frequency of behaviors.</description>
          <population>Latinx, English-learner students.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Parent academic enabling behavior at pre-test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.24" spread="7.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Parent academic enabling behavior at post-test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.76" spread="9.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>t-test, 2 sided</method>
            <method_desc>Within subjects paired t-tests.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>7.52</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Investigators tested whether pre-test to post-test change was significantly greater than 0 at P&lt;0.05.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>No adverse events (Deaths, serious adverse events, and nonserious adverse events) were assessed or reported for study participants.</desc>
      <group_list>
        <group group_id="E1">
          <title>Talk STEM Familia App</title>
          <description>This arm will test the feasibility of the Talk STEM Familia app to improve English language acquisition and family engagement and promote long-term educational and health outcomes among first- and second-generation Latino families.&#xD;
Talk STEM Familia app: The Talk STEM Familia app will be used to improve access to sound instruction in scientific academic vocabulary through the development of a technology-enhanced, culturally responsive smart-speaker tool that engages Latino families in culturally responsive academic language acquisition and practice in the home setting.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jessie Marquez</name_or_title>
      <organization>Oregon Research Behavioral Intervention Strategies, Inc. dba Behavioral Influents Innovations</organization>
      <phone>541-484-2123</phone>
      <email>jessie.marquez@influentsin.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03766906
org study id: MD013619-01
secondary id: R44MD013619
nct id: NCT03766906
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
After development of the Talk Stem Familia (TSF) smart-speaker application prototype, the
      study will evaluate the prototype's efficacy in a within-subjects pre-post design study. The
      sample will contain 50 parent-student/child dyads who will use the Alexa skill app for 6
      weeks.
Participants will receive an Echo Dot device enabled with the application prototype using a
      research Amazon account created for each dyad. The Echo Dot devices will be preconfigured by
      project staff onto research Amazon accounts. Parents will come to one of several orientation
      sessions to obtain their device and set-up instructions; staff will provide follow-up phone
      support as needed. Usage data will show how much the device is used by each dyad. To ensure
      exposure to TSF, parents will be asked to engage at least 3 times per week; project staff
      will prompt parents bi-weekly (via text, email, device notification, phone) during the 6-week
      intervention to encourage usage and provide needed technical support.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: One-arm, single-group, feasibility study with parent/student dyads.
primary purpose: Other
masking: None (Open Label)
measure: Student Academic Vocabulary Knowledge in English
time frame: Baseline (pretest) and 6 weeks (posttest)
description: The Student Academic Vocabulary Knowledge in English measure includes 18 multiple choice questions on the 18 words taught in the TSF app. The student chooses the correct word meaning from among four (4) possible responses. Students receive one point for each word correctly identified and points are summed across the 18 items. Scores can range from 0-18 and a higher score indicates greater vocabulary knowledge.
measure: Parent Academic Vocabulary Knowledge in Spanish
time frame: Baseline (pretest) and 6 weeks (posttest)
description: The Parent Academic Vocabulary Knowledge in Spanish measure includes 18 multiple choice questions on the 18 words taught in the TSF app. The parent chooses the correct word meaning from among four (4) possible responses. Parents receive one point for each word correctly identified and points are summed across the 18 items. Scores can range from 0-18 and a higher score indicates greater vocabulary knowledge.
measure: Student Academic Vocabulary Usage in English
time frame: Baseline (pretest) and 6 weeks (posttest)
description: The Student Academic Vocabulary Usage in English measure includes 18 true/false questions testing student knowledge of correct usage of the 18 academic vocabulary words taught in the TSF app.
measure: Parent Academic Vocabulary Usage in Spanish
time frame: Baseline (pretest) and 6 weeks (posttest)
description: The Parent Academic Vocabulary Usage in Spanish measure includes 18 true/false questions testing student knowledge of correct usage of the 18 academic vocabulary words taught in the TSF app.
measure: Student Engagement Instrument
time frame: Baseline (pretest) and 6 weeks (posttest)
description: The Student Engagement Instrument (SEI; Betts, Appleton, Reschly, et al., 2010) consists of three subscales (future aspirations and goals, 5 items, r = .80, family support for learning, 6 items, r = .79, and control and relevance of school work, 9 items, r = 70). The SEI scale for each item ranges from 1-"Strongly disagree" to 5- "Strongly agree" with 5 indicating greater self-efficacy (more positive). A sum score was computed for each subscale. For future aspirations the scores can range from 5 to 25 and a higher score indicates a more positive outcome; greater self-efficacy for future aspirations. For family support for learning the score can range from 6 to 30 and a higher scores indicates a more positive outcome; greater self-efficacy for family support for learning. For control and relevance of school work the scores can range from 9 to 45 and a greater score indicates a more positive outcome; greater self-efficacy for control and relevance of school work.
measure: The Efficacy to Influence School-related Performance Subscale of the Parental Self-Efficacy Scale
time frame: Baseline (pretest) and 6 weeks (posttest)
description: The Efficacy to Influence School-related Performance subscale of the Parental Self-Efficacy Scale (PSES; Bandura, et al., 2001) (completed in Spanish) to measure useful factors that reflect parents' perceptions of whether they can influence their child's academic performance. The PSES consists of 8 items on a 9-point scale ranging from 1 = "nothing" to 9 = "a great deal" . The measure has an internal reliability of .87. A mean composite score was computed and the scores can range from 1 to 9 with a higher score indicating a more positive outcome; greater levels of self-efficacy.
measure: Student Academic Language Learning Behaviors
time frame: Baseline (pretest) and 6 weeks (posttest)
description: The Student Academic Language Learning Behaviors measure includes 11 items asking students to estimate the frequency of discrete learning behaviors such as saying "scientific" words out loud in English and using "scientific" words in sentences. The measure uses a 4-point scale of frequency with 1 being "Not at all" and 4 being " 3-4 times a week." A sum score for the 11 items was computed and the scores could range from 11 to 44. Higher scores indicate a more positive outcome; greater frequency of behaviors.
measure: Parent Academic Enabling Behaviors
time frame: Baseline (pretest) and 6 weeks (posttest)
description: The Parent Academic Enabling Behaviors measure includes 13 items asking parents to estimate the frequency of their discrete academic enabling behaviors, such as helping their child learn the meaning of "scientific" words and using "scientific" words in a conversation with their child. The measure uses a 4-point scale of frequency with 1 being "Not at all" and 4 being " 3-4 times a week." A sum score including all 13 items was computed and can range between 13 and 52. Higher scores indicate a more positive outcome; greater frequency of behaviors.
arm group label: Talk STEM Familia App
arm group type: Experimental
description: This arm will test the feasibility of the Talk STEM Familia app to improve English language acquisition and family engagement and promote long-term educational and health outcomes among first- and second-generation Latino families.
intervention type: Behavioral
intervention name: Talk STEM Familia app
description: The Talk STEM Familia app will be used to improve access to sound instruction in scientific academic vocabulary through the development of a technology-enhanced, culturally responsive smart-speaker tool that engages Latino families in culturally responsive academic language acquisition and practice in the home setting.
arm group label: Talk STEM Familia App
criteria: 
gender: All
minimum age: 8 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: David R. Smith, PhD
role: Study Chair
affiliation: Oregon Research Behavioral Intervention Strategies, Inc.
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 