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LeadHer, a Gender-specific Teen Pregnancy Prevention Curriculum

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ClinicalTrials.gov Identifier: NCT03265314
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : August 29, 2017
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Celia Thomas, 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).

Condition or disease Intervention/treatment Phase
Teenage Pregnancy Behavioral: LeadHer Behavioral: Sassy Science Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Alternatives For Girls (AFG) LeadHer
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: 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.
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.

Placebo Comparator: 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.
Behavioral: 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.




Primary Outcome Measures :
  1. Avoidance of unprotected sex [ Time Frame: Up to 12 months post the beginning of intervention. ]
    Participants will refrain from having sex or avoid sex without protection.

  2. Use of birth control [ Time Frame: Up to 12 months post the beginning of intervention. ]
    Participants decided to have sex, they will use birth control.

  3. Presence of pregnancy [ Time Frame: Up to 12 months post the beginning of intervention. ]
    Participants will get pregnant.


Secondary Outcome Measures :
  1. Participants will report increased knowledge about Healthy Relationships [ Time Frame: 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.



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Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female and female-identifying participants.
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265314


Contacts
Contact: Celia Thomas, MPA 3133614000 ext 226 cthomas@alternativesforgirls.org
Contact: Tanisha King, MSW 3133614000 ext 303 tking@alternativesforgirls.org

Locations
United States, Michigan
Alternatives For Girls Recruiting
Detroit, Michigan, United States, 48208
Contact: Celia Thomas, MPA    313-361-4000 ext 226    cthomas@alternativesforgirls.org   
Contact: Tanisha King, MSW    3133614000 ext 303    tking@alternativesforgirls.org   
Sponsors and Collaborators
Alternatives For Girls
Department of Health and Human Services
Investigators
Principal Investigator: Celia Thomas, MPA Alternatives For Girls

Responsible Party: Celia Thomas, Chief Operating Officer, Alternatives For Girls
ClinicalTrials.gov Identifier: NCT03265314     History of Changes
Other Study ID Numbers: Alternatives For Girls
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: None, N/A.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No