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

NCT03265314 | Completed

• 1 other identifier: LeadHer
• Study Type: interventional
• Target: 508
• Locations: 1 country
• Sites: 1

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).

Conditions

Teenage Pregnancy

Outcome Measures

Primary Outcomes (3)

• Avoidance of unprotected sex

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

  Up to 12 months post the beginning of intervention.

• Use of birth control

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

  Up to 12 months post the beginning of intervention.

• Presence of pregnancy

  Participants will get pregnant.

  Up to 12 months post the beginning of intervention.

Secondary Outcomes (1)

• Participants will report increased knowledge about Healthy Relationships

  Up to 12 months post the beginning of intervention.

Study Arms (2)

LeadHer

EXPERIMENTAL

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.

Behavioral: LeadHer

Sassy Science

PLACEBO COMPARATOR

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.

Behavioral: Sassy Science

Interventions

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.

LeadHer

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.

Sassy Science

Eligibility Criteria

• Age: 14 Years - 19 Years
• Gender Eligibility Details: Female and female-identifying participants.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Alternatives For Girls: lead
• Department of Health and Human Services: collaborator

Study Sites (1)

Alternatives For Girls

Detroit, Michigan, 48208, United States

Location

Study Officials

• Celia Thomas, MPA

  Alternatives For Girls

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Operating Officer

Model Details: 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.

Study Record Dates

• First Submitted: August 24, 2017
• First Posted: August 29, 2017
• Study Start: August 1, 2017
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)