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

Not Applicable

Completed

• Conditions: Teenage Pregnancy
• Interventions: Behavioral: Sassy Science; Behavioral: LeadHer

• Registration Number: NCT03265314
• Lead Sponsor: Alternatives For Girls

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.

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2017-08-24
• Study First Submitted QC: 2017-08-25
• Study First Posted: 2017-08-29
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-28
• Last Update Posted: 2024-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 508

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sassy Science	Sassy Science	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.
LeadHer	LeadHer	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.

Primary Outcome Measures

Name	Time	Method
Avoidance of unprotected sex	Up to 12 months post the beginning of intervention.	Participants will refrain from having sex or avoid sex without protection.
Use of birth control	Up to 12 months post the beginning of intervention.	Participants decided to have sex, they will use birth control.
Presence of pregnancy	Up to 12 months post the beginning of intervention.	Participants will get pregnant.

Secondary Outcome Measures

Name	Time	Method
Participants will report increased knowledge about Healthy Relationships	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.

Trial Locations

Locations (1)

Alternatives For Girls; 🇺🇸 Detroit, Michigan, United States