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Completed

NCT Number: NCT03265314

LeadHer, a Gender-specific Teen Pregnancy Prevention Curriculum for Girls 15-19

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).

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Key information

Conditions

Age range

14 year–19 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Alternatives For Girls

Detroit, Michigan, 48208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Grade level: 8th grade through high school graduation; Race/ethnicity or tribe: As reflected in the Detroit, Wayne County, Michigan communities: African American, Latina, White, Mixed Races. At the time of the latest U.S. Census data, teens in Detroit were 81.9% African American, 9.7% Latino/a, 4.4% Caucasian, and 3.9% other races/ethnicities; Risk characteristics: Many will be at-risk by virtue of living within 200% of the federal poverty guidelines, doing poorly in local schools, being exposed to gang activities, and being sexually active; Other characteristics: living in Wayne County at the start of the study.

Exclusion criteria

  • Target population participants who are already in another pregnancy prevention program.

Treatment and study plan

LeadHer

Behavioral

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.

Sassy Science

Behavioral

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.

Primary outcomes

  1. Avoidance of unprotected sex

    Time frame: Up to 12 months post the beginning of intervention.

    Participants will refrain from having sex or avoid sex without protection.

  2. Use of birth control

    Time frame: Up to 12 months post the beginning of intervention.

    Participants decided to have sex, they will use birth control.

  3. Presence of pregnancy

    Time frame: Up to 12 months post the beginning of intervention.

    Participants will get pregnant.

Secondary outcomes

  1. Participants will report increased knowledge about Healthy Relationships

    Time frame: Up to 12 months post the beginning of intervention.

    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.

Sponsors and collaborators

Lead sponsor

Alternatives For Girls

Other

Collaborators

  • Department of Health and Human Services

Registry information

Official study title

Alternatives For Girls (AFG) LeadHer

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Aug 29, 2017
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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