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

Alternatives For Girls (AFG) LeadHer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03265314
Enrollment
508
Registered
2017-08-29
Start date
2017-08-01
Completion date
2022-04-30
Last updated
2024-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Teenage Pregnancy

Brief summary

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).

Detailed description

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.

Interventions

BEHAVIORALLeadHer

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.

BEHAVIORALSassy Science

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.

Sponsors

Department of Health and Human Services
CollaboratorFED
Alternatives For Girls
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

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.

Eligibility

Sex/Gender
FEMALE
Age
14 Years to 19 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Avoidance of unprotected sexUp to 12 months post the beginning of intervention.Participants will refrain from having sex or avoid sex without protection.
Use of birth controlUp to 12 months post the beginning of intervention.Participants decided to have sex, they will use birth control.
Presence of pregnancyUp to 12 months post the beginning of intervention.Participants will get pregnant.

Secondary

MeasureTime frameDescription
Participants will report increased knowledge about Healthy RelationshipsUp 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026