<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/NCT04501471</url>
  </required_header>
  <id_info>
    <org_study_id>2006-10685</org_study_id>
    <nct_id>NCT04501471</nct_id>
  </id_info>
  <brief_title>The Rural African American's Health Project</brief_title>
  <acronym>RAAFHP</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>University of Georgia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Georgia</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>
      This is an attention controlled randomized clinical trial testing the efficacy of the Strong&#xD;
      African American Families-Teen program. The two arm trial tests SAAF-T, a family centered&#xD;
      brief intervention against a similarly designed program that targets nutrition and exercise.&#xD;
      The outcomes examined include substance use and risky sexual behavior.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the past, African American adolescents in rural areas have avoided the high-risk behaviors&#xD;
      prevalent among youth in urban areas. Recent epidemiologic data, however, indicate that rural&#xD;
      African American youth use substances and engage in high-risk sexual behavior at rates equal&#xD;
      to or exceeding those in densely populated inner cities (Kogan, Berkel, Chen, Brody, &amp; Murry,&#xD;
      in press; Milhausen et al., 2003). These risk behaviors predict HIV infection, adolescent&#xD;
      parenthood, school dropout, involvement with the criminal justice system, and continued&#xD;
      substance use during early adulthood (Friedman et al., 1996; Miller, Boyer, &amp; Cotton, 2004;&#xD;
      St. Lawrence &amp; Scott, 1996; Tucker, Orlando, &amp; Ellickson, 2003). No developmentally&#xD;
      appropriate, culturally sensitive prevention programs have been developed to deter substance&#xD;
      use and high-risk sexual behavior among the several million African American adolescents who&#xD;
      live in the rural South (Murry &amp; Brody, 2004). To address this public health need, Drs. Brody&#xD;
      and Murry from the University of Georgia and Drs. DiClemente and Wingood from Emory&#xD;
      University designed a multicomponent, family-centered prevention program, the Strong African&#xD;
      American Families-Teen program (SAAF-T). We conducted a randomized prevention trial to test&#xD;
      the program's efficacy. The sample included 502 rural African American families with a&#xD;
      10th-grade student, half of whom will be assigned randomly to a prevention group and half to&#xD;
      an attention-control group. Pre-intervention, post-intervention, and long-term follow-up&#xD;
      assessments of adolescents' substance use and high-risk sexual behavior were gathered from&#xD;
      the entire sample. Specific aims were to test hypotheses that rural African American&#xD;
      adolescents randomly assigned to participate in SAAF-T, compared to attention-control&#xD;
      participants, will demonstrate lower rates of substance use and risky sexual behavior.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2005</start_date>
  <completion_date type="Actual">September 2010</completion_date>
  <primary_completion_date type="Actual">September 2010</primary_completion_date>
  <phase>Phase 2</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>Double (Participant, Care Provider)</masking>
    <masking_description>Participants and providers were not aware that the Fuel condition was considered an attention control</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Substance Use</measure>
    <time_frame>Follow up period baseline to 22 months post-baseline</time_frame>
    <description>Index of alcohol, cigarette, and marijuana use in the past 3 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Risky Sexual Behavior</measure>
    <time_frame>Follow up period baseline to 22 months post-baseline</time_frame>
    <description>Count of unprotected intercourse</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depressive symptomology- CES-D Scale</measure>
    <time_frame>Symptoms in past week assessed, follow up period includes baseline to 22 months post baseline</time_frame>
    <description>Symptoms of depression, 20 items</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conduct Problems</measure>
    <time_frame>Follow up period baseline to 22 months post-baseline</time_frame>
    <description>Using 14 questions from the National Youth Survey,adolescents indicated the frequency during the past 6 months with which they had fought, stolen, been truant from school, or been suspended from school. Adolescents' responses were summed, and the sum constituted the conduct problems score.13</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Discussion Quality Scale</measure>
    <time_frame>Follow up period -baseline to 6 month posttest</time_frame>
    <description>The DQS assessed communication frequency and quality for discussions of difficult issues.</description>
  </other_outcome>
  <other_outcome>
    <measure>Family Support Inventory</measure>
    <time_frame>Follow up period -baseline to 6 month posttest</time_frame>
    <description>The FSI measured provision of emotional support, involvement, and quality of caregiver-youth communication</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">502</enrollment>
  <condition>SAAF-T</condition>
  <condition>FUEL for Families</condition>
  <arm_group>
    <arm_group_label>SAAF-T</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received a 5 session, 10-hour family centered prevention program designed to prevent substance use, conduct problems, and risky sexual behavior</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fuel for Families</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received a 5 session, 10 hour family centered program that focused on healthy nutrition and exercise.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SAAF-T</intervention_name>
    <description>Parents and youth meet separately during first hour to engage in activities then meet in family groups during the second hours of each session.</description>
    <arm_group_label>SAAF-T</arm_group_label>
    <other_name>Strong AFrican American Families-Teen Program</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Fuel for Families</intervention_name>
    <description>Parents and youth meet separately during first hour to engage in activities then meet in family groups during the second hours of each session.</description>
    <arm_group_label>Fuel for Families</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Self-identified Black or African American&#xD;
&#xD;
          -  10th grade in public school in targeted county&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to participate in group-based intervention due to mental health&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 11, 2020</last_update_submitted>
  <last_update_submitted_qc>August 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Georgia</investigator_affiliation>
    <investigator_full_name>Gene H. Brody</investigator_full_name>
    <investigator_title>Regents Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to share data</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>July 6, 2022</submitted>
    <returned>May 12, 2023</returned>
  </pending_results>
  <!-- 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/NCT04501471
org study id: 2006-10685
nct id: NCT04501471
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is an attention controlled randomized clinical trial testing the efficacy of the Strong
      African American Families-Teen program. The two arm trial tests SAAF-T, a family centered
      brief intervention against a similarly designed program that targets nutrition and exercise.
      The outcomes examined include substance use and risky sexual behavior.
In the past, African American adolescents in rural areas have avoided the high-risk behaviors
      prevalent among youth in urban areas. Recent epidemiologic data, however, indicate that rural
      African American youth use substances and engage in high-risk sexual behavior at rates equal
      to or exceeding those in densely populated inner cities (Kogan, Berkel, Chen, Brody, & Murry,
      in press; Milhausen et al., 2003). These risk behaviors predict HIV infection, adolescent
      parenthood, school dropout, involvement with the criminal justice system, and continued
      substance use during early adulthood (Friedman et al., 1996; Miller, Boyer, & Cotton, 2004;
      St. Lawrence & Scott, 1996; Tucker, Orlando, & Ellickson, 2003). No developmentally
      appropriate, culturally sensitive prevention programs have been developed to deter substance
      use and high-risk sexual behavior among the several million African American adolescents who
      live in the rural South (Murry & Brody, 2004). To address this public health need, Drs. Brody
      and Murry from the University of Georgia and Drs. DiClemente and Wingood from Emory
      University designed a multicomponent, family-centered prevention program, the Strong African
      American Families-Teen program (SAAF-T). We conducted a randomized prevention trial to test
      the program's efficacy. The sample included 502 rural African American families with a
      10th-grade student, half of whom will be assigned randomly to a prevention group and half to
      an attention-control group. Pre-intervention, post-intervention, and long-term follow-up
      assessments of adolescents' substance use and high-risk sexual behavior were gathered from
      the entire sample. Specific aims were to test hypotheses that rural African American
      adolescents randomly assigned to participate in SAAF-T, compared to attention-control
      participants, will demonstrate lower rates of substance use and risky sexual behavior.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Care Provider)
masking description: Participants and providers were not aware that the Fuel condition was considered an attention control
measure: Substance Use
time frame: Follow up period baseline to 22 months post-baseline
description: Index of alcohol, cigarette, and marijuana use in the past 3 months
measure: Risky Sexual Behavior
time frame: Follow up period baseline to 22 months post-baseline
description: Count of unprotected intercourse
measure: Depressive symptomology- CES-D Scale
time frame: Symptoms in past week assessed, follow up period includes baseline to 22 months post baseline
description: Symptoms of depression, 20 items
measure: Conduct Problems
time frame: Follow up period baseline to 22 months post-baseline
description: Using 14 questions from the National Youth Survey,adolescents indicated the frequency during the past 6 months with which they had fought, stolen, been truant from school, or been suspended from school. Adolescents' responses were summed, and the sum constituted the conduct problems score.13
measure: Discussion Quality Scale
time frame: Follow up period -baseline to 6 month posttest
description: The DQS assessed communication frequency and quality for discussions of difficult issues.
measure: Family Support Inventory
time frame: Follow up period -baseline to 6 month posttest
description: The FSI measured provision of emotional support, involvement, and quality of caregiver-youth communication
arm group label: SAAF-T
arm group type: Experimental
description: Participants received a 5 session, 10-hour family centered prevention program designed to prevent substance use, conduct problems, and risky sexual behavior
arm group label: Fuel for Families
arm group type: Placebo Comparator
description: Participants received a 5 session, 10 hour family centered program that focused on healthy nutrition and exercise.
intervention type: Behavioral
intervention name: SAAF-T
description: Parents and youth meet separately during first hour to engage in activities then meet in family groups during the second hours of each session.
arm group label: SAAF-T
other name: Strong AFrican American Families-Teen Program
intervention type: Behavioral
intervention name: Fuel for Families
description: Parents and youth meet separately during first hour to engage in activities then meet in family groups during the second hours of each session.
arm group label: Fuel for Families
criteria: 
gender: All
minimum age: 15 Years
maximum age: 17 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Georgia
investigator full name: Gene H. Brody
investigator title: Regents Professor
sharing ipd: No
ipd description: There is no plan to share data
submitted: July 6, 2022
returned: May 12, 2023