<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/NCT03265314</url>
  </required_header>
  <id_info>
    <org_study_id>Alternatives For Girls</org_study_id>
    <nct_id>NCT03265314</nct_id>
  </id_info>
  <brief_title>LeadHer, a Gender-specific Teen Pregnancy Prevention Curriculum</brief_title>
  <official_title>Alternatives For Girls (AFG) LeadHer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alternatives For Girls</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Department of Health and Human Services</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Alternatives For Girls</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>
      Alternatives For Girls (AFG) is offering LeadHer as a gender-specific teen pregnancy&#xD;
      prevention curriculum to girls between the ages of 14-19 years old who live in Wayne County,&#xD;
      MI. The curriculum seeks to demonstrate that girls who participate in LeadHer will show&#xD;
      increased rates of avoidance of unprotected sex, will show increased use of birth control and&#xD;
      reduced rates of pregnancy. LeadHer will run over a 6-session period covering topics designed&#xD;
      to prevent teen pregnancy and develop girls into leaders. The sessions will be co-led by&#xD;
      youth (Peer Educators).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      LeadHer is a 30-hour curriculum provided under rigorous evaluation, random assignment&#xD;
      protocols and covering factual information related to sexual intercourse, including the risks&#xD;
      of sex, sexually transmitted infections and use of birth control, along with the following&#xD;
      adult preparation topics: Healthy relationships, Adolescent development, Healthy life skills,&#xD;
      and Educational and career success.&#xD;
&#xD;
      The project is designed to run for five years; years 2 through 4 will involve providing the&#xD;
      intervention curriculum to a total of 300 girls. There will be a control group, Sassy Science&#xD;
      running in tandem with LeadHer for 300 girls. Groups will take place at the Alternatives For&#xD;
      Girls facility as well as off-site within the community at local schools, primarily during&#xD;
      after-school hours and community centers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">April 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">April 30, 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>
    <intervention_model_description>Person-level random control trial. Participants randomly assigned to intervention (LeadHer) OR control (Sassy Science). Unit of analysis is individual (not groups/clusters). Baseline data collection is before randomization, in enrollment sessions, to prevent differential attrition post-randomization. Randomization via database developed for project. Evaluation Strategies (AFG's independent partner) developed an automated randomization method via random number generator. All randomized participants are tracked for study duration. In database, the button disappears once randomization occurs. The button is not active until consent/assent and all baseline measures are input to database. This randomization will occur after enrollment session, once enough participants for a cohort are enrolled. This helps prevent post-random sample loss. Randomization is electronic, via database, before first session. Once randomization occurs, AFG contacts enrolled girls about which their assigned program.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Avoidance of unprotected sex</measure>
    <time_frame>Up to 12 months post the beginning of intervention.</time_frame>
    <description>Participants will refrain from having sex or avoid sex without protection.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Use of birth control</measure>
    <time_frame>Up to 12 months post the beginning of intervention.</time_frame>
    <description>Participants decided to have sex, they will use birth control.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of pregnancy</measure>
    <time_frame>Up to 12 months post the beginning of intervention.</time_frame>
    <description>Participants will get pregnant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Participants will report increased knowledge about Healthy Relationships</measure>
    <time_frame>Up to 12 months post the beginning of intervention.</time_frame>
    <description>Participants will report increased knowledge regarding ways to develop healthy relationships with parent/trusted adults and regarding dating violence. This will be collected via pre-tests and post-tests.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">508</enrollment>
  <condition>Teenage Pregnancy</condition>
  <arm_group>
    <arm_group_label>LeadHer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The LeadHer curriculum is presented to the target population over a total of 30 hours. The program addresses the following adult preparation subjects: Healthy relationships, Adolescent development, Healthy life skills, Educational and career success. The LeadHer curriculum is also accompanied by a mobile application.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sassy Science</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The Sassy Science curriculum is presented to the target population over a total of 30 hours. The program addresses the following subjects: States of Matter, Math, Engineering, Chemistry, Arts and Crafts, Sweet Treats and Celebrations. The curriculum does not have a mobile application.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>LeadHer</intervention_name>
    <description>The 30-hour curriculum is delivered for five hours per week, either split over multiple after school sessions or one five-hour-long session conducted at AFG headquarters or a community-based partner site.</description>
    <arm_group_label>LeadHer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sassy Science</intervention_name>
    <description>The 30-hour curriculum is delivered for five hours per week, either split over multiple after school sessions or one five-hour-long session conducted at AFG headquarters or a community-based partner site.</description>
    <arm_group_label>Sassy Science</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Grade level: 8th grade through high school graduation; Race/ethnicity or tribe: As&#xD;
             reflected in the Detroit, Wayne County, Michigan communities: African American,&#xD;
             Latina, White, Mixed Races. At the time of the latest U.S. Census data, teens in&#xD;
             Detroit were 81.9% African American, 9.7% Latino/a, 4.4% Caucasian, and 3.9% other&#xD;
             races/ethnicities; Risk characteristics: Many will be at-risk by virtue of living&#xD;
             within 200% of the federal poverty guidelines, doing poorly in local schools, being&#xD;
             exposed to gang activities, and being sexually active; Other characteristics: living&#xD;
             in Wayne County at the start of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Target population participants who are already in another pregnancy prevention&#xD;
             program.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female and female-identifying participants.</gender_description>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Celia Thomas, MPA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alternatives For Girls</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alternatives For Girls</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>April 15, 2022</last_update_submitted>
  <last_update_submitted_qc>April 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Alternatives For Girls</investigator_affiliation>
    <investigator_full_name>Celia Thomas</investigator_full_name>
    <investigator_title>Chief Operating Officer</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>None, N/A.</ipd_description>
  </patient_data>
  <!-- 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/NCT03265314
org study id: Alternatives For Girls
nct id: NCT03265314
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Alternatives For Girls (AFG) is offering LeadHer as a gender-specific teen pregnancy
      prevention curriculum to girls between the ages of 14-19 years old who live in Wayne County,
      MI. The curriculum seeks to demonstrate that girls who participate in LeadHer will show
      increased rates of avoidance of unprotected sex, will show increased use of birth control and
      reduced rates of pregnancy. LeadHer will run over a 6-session period covering topics designed
      to prevent teen pregnancy and develop girls into leaders. The sessions will be co-led by
      youth (Peer Educators).
LeadHer is a 30-hour curriculum provided under rigorous evaluation, random assignment
      protocols and covering factual information related to sexual intercourse, including the risks
      of sex, sexually transmitted infections and use of birth control, along with the following
      adult preparation topics: Healthy relationships, Adolescent development, Healthy life skills,
      and Educational and career success.

      The project is designed to run for five years; years 2 through 4 will involve providing the
      intervention curriculum to a total of 300 girls. There will be a control group, Sassy Science
      running in tandem with LeadHer for 300 girls. Groups will take place at the Alternatives For
      Girls facility as well as off-site within the community at local schools, primarily during
      after-school hours and community centers.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Person-level random control trial. Participants randomly assigned to intervention (LeadHer) OR control (Sassy Science). Unit of analysis is individual (not groups/clusters). Baseline data collection is before randomization, in enrollment sessions, to prevent differential attrition post-randomization. Randomization via database developed for project. Evaluation Strategies (AFG's independent partner) developed an automated randomization method via random number generator. All randomized participants are tracked for study duration. In database, the button disappears once randomization occurs. The button is not active until consent/assent and all baseline measures are input to database. This randomization will occur after enrollment session, once enough participants for a cohort are enrolled. This helps prevent post-random sample loss. Randomization is electronic, via database, before first session. Once randomization occurs, AFG contacts enrolled girls about which their assigned program.
primary purpose: Prevention
masking: Double (Participant, Care Provider)
measure: Avoidance of unprotected sex
time frame: Up to 12 months post the beginning of intervention.
description: Participants will refrain from having sex or avoid sex without protection.
measure: Use of birth control
time frame: Up to 12 months post the beginning of intervention.
description: Participants decided to have sex, they will use birth control.
measure: Presence of pregnancy
time frame: Up to 12 months post the beginning of intervention.
description: Participants will get pregnant.
measure: Participants will report increased knowledge about Healthy Relationships
time frame: Up to 12 months post the beginning of intervention.
description: Participants will report increased knowledge regarding ways to develop healthy relationships with parent/trusted adults and regarding dating violence. This will be collected via pre-tests and post-tests.
arm group label: LeadHer
arm group type: Experimental
description: The LeadHer curriculum is presented to the target population over a total of 30 hours. The program addresses the following adult preparation subjects: Healthy relationships, Adolescent development, Healthy life skills, Educational and career success. The LeadHer curriculum is also accompanied by a mobile application.
arm group label: Sassy Science
arm group type: Placebo Comparator
description: The Sassy Science curriculum is presented to the target population over a total of 30 hours. The program addresses the following subjects: States of Matter, Math, Engineering, Chemistry, Arts and Crafts, Sweet Treats and Celebrations. The curriculum does not have a mobile application.
intervention type: Behavioral
intervention name: LeadHer
description: The 30-hour curriculum is delivered for five hours per week, either split over multiple after school sessions or one five-hour-long session conducted at AFG headquarters or a community-based partner site.
arm group label: LeadHer
intervention type: Behavioral
intervention name: Sassy Science
description: The 30-hour curriculum is delivered for five hours per week, either split over multiple after school sessions or one five-hour-long session conducted at AFG headquarters or a community-based partner site.
arm group label: Sassy Science
criteria: 
gender: Female
gender based: Yes
gender description: Female and female-identifying participants.
minimum age: 14 Years
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Celia Thomas, MPA
role: Principal Investigator
affiliation: Alternatives For Girls
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Alternatives For Girls
investigator full name: Celia Thomas
investigator title: Chief Operating Officer
sharing ipd: No
ipd description: None, N/A.