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

Teenage Pregnancy Clinical Trial

Official title:

Alternatives For Girls (AFG) LeadHer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03265314
• Other study ID #: LeadHer
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: April 30, 2022

Study information

• Verified date: December 2023
• Source: Alternatives For Girls
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 508
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Teenage Pregnancy

Intervention

Behavioral:
• LeadHer
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
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.

Locations

Country	Name	City	State
United States	Alternatives For Girls	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Alternatives For Girls	Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Avoidance of unprotected sex	Participants will refrain from having sex or avoid sex without protection.	Up to 12 months post the beginning of intervention.
Primary	Use of birth control	Participants decided to have sex, they will use birth control.	Up to 12 months post the beginning of intervention.
Primary	Presence of pregnancy	Participants will get pregnant.	Up to 12 months post the beginning of intervention.
Secondary	Participants will report increased knowledge about Healthy Relationships	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.	Up to 12 months post the beginning of intervention.