<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/NCT03009539</url>
  </required_header>
  <id_info>
    <org_study_id>20160035</org_study_id>
    <secondary_id>1R01DA040756</secondary_id>
    <nct_id>NCT03009539</nct_id>
  </id_info>
  <brief_title>eHealth Evidence-based Intervention (EBI) for Latino Youth in Primary Care</brief_title>
  <official_title>Evaluating the Effectiveness of an eHealth EBI for Latino Youth in Primary Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Miami</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>
      The purpose of this study is to test the relative effectiveness of a Hispanic-specific&#xD;
      eHealth intervention, &quot;e-Health Familias Unidas,&quot; in preventing and reducing drug use, sexual&#xD;
      risk behaviors, and STIs among Hispanic youth in primary care. Families will be recruited&#xD;
      through four pediatric primary care settings. Pediatric staff and research team members,&#xD;
      including nurse assistants and mental health professionals, will implement eHealth Familias&#xD;
      Unidas.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 18, 2017</start_date>
  <completion_date type="Actual">December 18, 2022</completion_date>
  <primary_completion_date type="Actual">December 18, 2022</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in drug use</measure>
    <time_frame>Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months</time_frame>
    <description>Change in drug use will be reported as the number of days of reported drug use for the previous 90 days with questions from Monitoring the Future</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in unprotected sexual behavior</measure>
    <time_frame>Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months</time_frame>
    <description>Change in unprotected sexual behavior will be reported as endorsement of having had sex without a condom during the previous 90 days using the Sexual Behavior Instrument</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in incidence of sexually transmitted infection</measure>
    <time_frame>Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months</time_frame>
    <description>Sexually transmitted infection incidence (i.e., gonorrhea and chlamydia) will be analyzed via a Polymerase Chain Reaction (PCR) from urine specimens</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in family functioning as assessed by the Parenting Practices Questionnaire</measure>
    <time_frame>Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months</time_frame>
    <description>Change in family functioning will be reported using the Parenting Practices Questionnaire . Response range varies based on questions, but most response items range from 0 to 4 with higher values indicating better parenting.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in family functioning as assessed by the Parent Relationship with Peer Group</measure>
    <time_frame>Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months</time_frame>
    <description>Change in family functioning will be reported using the Parent Relationship with Peer Group. The Parent Relationship with Peer Group is a six item measure with response items ranging from 0 to 24. Higher scores indicate better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in family functioning as assessed by the Parent-Adolescent Communication Scale</measure>
    <time_frame>Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months</time_frame>
    <description>Change in family functioning will be reported using the Parent-Adolescent Communication Scale. The Parent-Adolescent Communication Scale is a twenty-item questionnaire with a total score ranging from 20 to 100 with higher scores indicating better communication.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">456</enrollment>
  <condition>Sexual Risk Behavior</condition>
  <condition>Drug Use</condition>
  <condition>Family Functioning</condition>
  <arm_group>
    <arm_group_label>eHealth Familias Unidas Primary Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>eHealth Familias Unidas consists of 12 sessions: eight (12 - 15 minute) &quot;mock&quot; parent sessions in Spanish and four (30 - 45 minute) online family sessions delivered in either Spanish and/or English.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as Usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in this condition will not receive an intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>eHealth Familias Unidas Primary Care</intervention_name>
    <description>The experimental condition will consist of &quot;eHealth Familias Unidas Primary Care.&quot; eHealth Familias Unidas Primary Care is an adaptation of the face-to-face version of Familias Unidas. As with face-to-face Familias Unidas, eHealth Familias Unidas Primary Care aims to prevent drug use, sexual risk behaviors, and STIs by improving family functioning. Similar to face-to-face Familias Unidas, eHealth Familias Unidas is a multi-level intervention that targets risk and protective factors at the multiple systems affecting the youth and youths' family.</description>
    <arm_group_label>eHealth Familias Unidas Primary Care</arm_group_label>
    <other_name>eHealth Familias Unidas</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female and male adolescents of Hispanic immigrant origin, defined by at least one&#xD;
             parent born in a Spanish speaking country of the Americas. Parent must understand&#xD;
             Spanish given that parent sessions are delivered in Spanish.&#xD;
&#xD;
          -  Adolescent between the ages of 12 - 17 years&#xD;
&#xD;
          -  Adolescent living with an adult primary caregiver who is willing to participate&#xD;
&#xD;
          -  Families must have broadband internet access on a device, including (but not limited&#xD;
             to) a smart phone, iPad, tablet, a home computer or a computer at another location&#xD;
             (e.g., school, library, etc.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Families reporting plans to move out of the South Florida area during the study period&#xD;
&#xD;
          -  Families reporting that adolescent has been diagnosed with a developmental delay&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guillermo Prado, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>PrimeCare Pediatrics</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ileana Fuentes Clinic</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ambulatory Care Center West Pediatrics at Jackson Memorial Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UM Pediatric Mobile Clinic</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UM UHealth Pediatrics at the Professional Arts Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Borinquean Medical Centers</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33137</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Borinquen Medical Centers</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33137</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kidstown Pediatrics</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33137</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Belkys Bravo Clinic</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33145</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Castro Pediatrics</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33173</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami UHealth Pediatrics at Kendall</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S. Florida Pediatric Partners</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33196</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>January 5, 2023</last_update_submitted>
  <last_update_submitted_qc>January 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Guillermo Prado</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Prevention with Hispanic youth</keyword>
  <keyword>eHealth preventive intervention in primary care</keyword>
  <keyword>Hispanic adolescent</keyword>
  <keyword>Familias Unidas</keyword>
  <keyword>eHealth Familias Unidas</keyword>
  <keyword>effectiveness trial</keyword>
  <keyword>sexually transmitted disease</keyword>
  <keyword>parent-centered</keyword>
  <keyword>Hispanic</keyword>
  <keyword>sexual risk behavior</keyword>
  <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 28, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT03009539/Prot_SAP_002.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>April 23, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT03009539/ICF_003.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03009539
org study id: 20160035
secondary id: 1R01DA040756
nct id: NCT03009539
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to test the relative effectiveness of a Hispanic-specific
      eHealth intervention, "e-Health Familias Unidas," in preventing and reducing drug use, sexual
      risk behaviors, and STIs among Hispanic youth in primary care. Families will be recruited
      through four pediatric primary care settings. Pediatric staff and research team members,
      including nurse assistants and mental health professionals, will implement eHealth Familias
      Unidas.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in drug use
time frame: Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months
description: Change in drug use will be reported as the number of days of reported drug use for the previous 90 days with questions from Monitoring the Future
measure: Change in unprotected sexual behavior
time frame: Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months
description: Change in unprotected sexual behavior will be reported as endorsement of having had sex without a condom during the previous 90 days using the Sexual Behavior Instrument
measure: Change in incidence of sexually transmitted infection
time frame: Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months
description: Sexually transmitted infection incidence (i.e., gonorrhea and chlamydia) will be analyzed via a Polymerase Chain Reaction (PCR) from urine specimens
measure: Change in family functioning as assessed by the Parenting Practices Questionnaire
time frame: Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months
description: Change in family functioning will be reported using the Parenting Practices Questionnaire . Response range varies based on questions, but most response items range from 0 to 4 with higher values indicating better parenting.
measure: Change in family functioning as assessed by the Parent Relationship with Peer Group
time frame: Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months
description: Change in family functioning will be reported using the Parent Relationship with Peer Group. The Parent Relationship with Peer Group is a six item measure with response items ranging from 0 to 24. Higher scores indicate better outcomes.
measure: Change in family functioning as assessed by the Parent-Adolescent Communication Scale
time frame: Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months
description: Change in family functioning will be reported using the Parent-Adolescent Communication Scale. The Parent-Adolescent Communication Scale is a twenty-item questionnaire with a total score ranging from 20 to 100 with higher scores indicating better communication.
arm group label: eHealth Familias Unidas Primary Care
arm group type: Experimental
description: eHealth Familias Unidas consists of 12 sessions: eight (12 - 15 minute) "mock" parent sessions in Spanish and four (30 - 45 minute) online family sessions delivered in either Spanish and/or English.
arm group label: Treatment as Usual
arm group type: No Intervention
description: Participants in this condition will not receive an intervention.
intervention type: Behavioral
intervention name: eHealth Familias Unidas Primary Care
description: The experimental condition will consist of "eHealth Familias Unidas Primary Care." eHealth Familias Unidas Primary Care is an adaptation of the face-to-face version of Familias Unidas. As with face-to-face Familias Unidas, eHealth Familias Unidas Primary Care aims to prevent drug use, sexual risk behaviors, and STIs by improving family functioning. Similar to face-to-face Familias Unidas, eHealth Familias Unidas is a multi-level intervention that targets risk and protective factors at the multiple systems affecting the youth and youths' family.
arm group label: eHealth Familias Unidas Primary Care
other name: eHealth Familias Unidas
criteria: 
gender: All
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Guillermo Prado, Ph.D.
role: Principal Investigator
affiliation: University of Miami
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Guillermo Prado
investigator title: Professor
sharing ipd: No
provided document: 
provided document: 