Clinical trial NCT03265314: LeadHer, a Gender-specific Teen Pregnancy Prevention Curriculum for Girls 15-19
Official title: Alternatives For Girls (AFG) LeadHer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Teenage Pregnancy
Lead sponsor: Alternatives For Girls
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2017-08-29
Enrollment: 508
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Avoidance of unprotected sex
timeFrame: Up to 12 months post the beginning of intervention.
measure: Use of birth control
timeFrame: Up to 12 months post the beginning of intervention.
measure: Presence of pregnancy
timeFrame: Up to 12 months post the beginning of intervention.
Secondary outcomes:
measure: Participants will report increased knowledge about Healthy Relationships
timeFrame: Up to 12 months post the beginning of intervention.
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Alternatives For Girls
state: Michigan
Study officials:
affiliation: Alternatives For Girls
name: Celia Thomas, MPA
role: PRINCIPAL_INVESTIGATOR
References: