Teenage PregnancyNCT03265314
LeadHer, a Gender-specific Teen Pregnancy Prevention Curriculum for Girls 15-19
A study testing LeadHer and Sassy Science in people with Teenage Pregnancy, run by Alternatives For Girls at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Teenage Pregnancy
- What is being tested?
- LeadHer and Sassy Science
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 508 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Target population participants who are already in another pregnancy prevention program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alternatives For Girls (AFG) LeadHer
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).
Read the 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.
- Conditions
- Teenage Pregnancy
- Being tested
- LeadHer, Sassy Science
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeadHerBehavioural
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 ScienceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Sassy Science |
What is being measured
The primary outcome is the main question the study is designed to answer.
Avoidance of unprotected sex
Participants will refrain from having sex or avoid sex without protection.
Measured: Up to 12 months post the beginning of intervention.
Use of birth control
Participants decided to have sex, they will use birth control.
Measured: Up to 12 months post the beginning of intervention.
Presence of pregnancy
Participants will get pregnant.
Measured: Up to 12 months post the beginning of intervention.
Secondary outcomes (1)
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.
Measured: Up to 12 months post the beginning of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start1 Aug 2017
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Teenage PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider
- Enrolment
- 508 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alternatives For Girls
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Principal investigator, Celia Thomas, Alternatives For Girls
- Investigators
- Celia Thomas, MPA, Principal investigator, Alternatives For Girls
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265314
- Sponsor's protocol ID
- LeadHer
- Status last verified
- Dec 2023
- First submitted
- 24 Aug 2017
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: None, N/A.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternatives For Girls (AFG) LeadHer
- ClinicalTrials.gov ID
- NCT03265314
- Acronym / sponsor ID
- LeadHer
- Conditions
- Teenage Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 508 participants (actual)
- Lead sponsor
- Alternatives For GirlsUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| LeadHer | Experimental | Behavioral: LeadHerThe 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. |
| Sassy Science | Placebo comparator | Behavioral: Sassy ScienceThe 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. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Target population participants who are already in another pregnancy prevention program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LeadHerThe 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. | Behavioural | LeadHer |
| Sassy ScienceThe 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. | Behavioural | Sassy Science |
Primary outcome
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.
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.
Presence of pregnancy
Time frame: Up to 12 months post the beginning of intervention.
Participants will get pregnant.
1 secondary outcome
Participants will report increased knowledge about Healthy Relationships
Time frame: Up to 12 months post the beginning of intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: No. None, N/A.
Related trials for Teenage Pregnancy
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
Active, not recruitingPhase 3
A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids)
Chronic Kidney Disease
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
RecruitingPhase 3
A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)
Focal Segmental Glomerulosclerosis
Recruiting
AYAHIV Role-based Responsibilities for Oncology-focused Workforce (ARROW)
Cervical Cancer, Kaposi Sarcoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Celia Thomas, MPA principal investigator
Alternatives For Girls
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LeadHer and Sassy Science in people with Teenage Pregnancy, run by Alternatives For Girls at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Avoidance of unprotected sex (time frame: Up to 12 months post the beginning of intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.