Abstinence, SexNCT06217809
EmpowHer is Prevention Curriculum for Youth Ages 10-15 Years.
A study testing The intervention curriculum addresses sexual activity, abstinence, and adulthood preparation topics. in people with Abstinence, Sex, run by Alternatives For Girls at 1 site in United States.
Trial summary
Alternatives For Girls (AFG's) EmpowHer curriculum is a program for youth who are 10-15 years of age. The curriculum is youth-co-led, and innovative (using online platforms and digitized presentation of material. Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Abstinence, Sex
- What is being tested?
- The intervention curriculum addresses sexual activity, abstinence, and adulthood preparation topics.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 552 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2022to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Youth who are 10 -15 years of age at the start of the study and residing in Detroit, Outer-Wayne County or geographically similar areas at the time of enrollment will be eligible to participate in the study.
Who cannot join
- Participants who are currently utilizing other services from Alternatives For Girls (AFG), children of AFG staff and youth participating in other sexual health education programs will not be eligible to participate and will be wait-listed until they are no longer receiving other services from AFG (i.e., after-school programs, summer day camps, mentoring, youth leadership programs, and shelter services). These services are unrelated to the study/sexual health education and do not include EmpowHer or Sassy Science. If siblings were to be enrolled, one would be randomly assigned, and the rest would be allowed to participate in the same group as the study sibling but not counted in the evaluation. This is to prevent possible contamination between conditions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Alternatives For Girls
Detroit, Michigan, 48208
Celia Thomas, MPA, 3133614000 ext. 226, cthomas@alternativesforgirls.org
Jonquil Bertschi, JD, 3133614000, jbertschi@alternativesforgirls.org
About this study
Alternatives For Girls (AFG's) EmpowHer curriculum is a program for youth who are 10-15 years of age. The curriculum is youth-co-led, and innovative (using online platforms and digitized presentation of material. EmpowHer addresses four adulthood preparation subjects (APS), such as parent-child communication, healthy relationships, adolescent development, and healthy life skills, and can be implemented as an after-school, in/out-of-school-time program.
- Conditions
- Abstinence, Sex
- Being tested
- The intervention curriculum addresses sexual activity, abstinence, and adulthood preparation topics.
- Medical subject headings
- Sexual Abstinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The intervention curriculum addresses sexual activity, abstinence, and adulthood preparation topics.Behavioural
The intervention is youth-co-led, and targets youth in Detroit, Out-Wayne County or geographically similar areas through a 16-unit curriculum totaling 20 hours. Each participant and their parent/guardian will also receive one individual session with a case planner. Parents will receive 3 hours of parental support group. EmpowHer contains lessons and activities focusing on topics relating to abstinence, and teen pregnancy prevention, focusing on adulthood preparation subjects (APS), such as parent-child communication, adolescent development, healthy life skills, and healthy relationships.
| Study group | Role | What they receive |
|---|---|---|
| EmpowHer | Experimental | The intervention curriculum is designed to address abstinence, and adulthood preparation topics. Receives: Behavioral: The intervention curriculum addresses sexual activity, abstinence, and adulthood preparation topics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recent sexual activity
Do participants in the curriculum model (EmpowHer) show reduced rates of sexual activity at 9-month follow up compared to those in a control curriculum (Sassy Science)?
Measured: At 9-month follow up.
Abstinence
Do participants in the curriculum model (EmpowHer) show increased rates of abstinence at (a) 6-month follow-up, and (b) 9-month follow up compared to those in control curriculum (Sassy Science)?
Measured: At 9-month follow up.
Secondary outcomes (1)
Healthy relationship knowledge
Do participants in the curriculum model (EmpowHer) show increased healthy relationship knowledge at post-test compared to those in a control curriculum (Sassy Science)?
Measured: After 20-hour intervention (at post-test).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start22 Feb 2022
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abstinence, SexStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 552 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alternatives For Girls
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Celia Thomas, Alternatives For Girls
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217809
- Sponsor's protocol ID
- EmpowHer
- Status last verified
- Aug 2025
- First submitted
- 28 Dec 2023
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not sharing.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EmpowHer is Prevention Curriculum for Youth Ages 10-15 Years.
- ClinicalTrials.gov ID
- NCT06217809
- Acronym / sponsor ID
- EmpowHer
- Conditions
- Abstinence, Sex
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 552 participants (estimated)
- Lead sponsor
- Alternatives For GirlsUniversity, hospital or other
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 23 Jan 2024 (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's) EmpowHer curriculum is a program for youth who are 10-15 years of age. The curriculum is youth-co-led, and innovative (using online platforms and digitized presentation of material. EmpowHer addresses four adulthood preparation subjects (APS), such as parent-child communication, healthy relationships, adolescent development, and healthy life skills, and can be implemented as an after-school, in/out-of-school-time program.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EmpowHer | Experimental | Behavioral: The intervention curriculum addresses sexual activity, abstinence, and adulthood preparation topics.The intervention curriculum is designed to address abstinence, and adulthood preparation topics. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Youth who are 10 -15 years of age at the start of the study and residing in Detroit, Outer-Wayne County or geographically similar areas at the time of enrollment will be eligible to participate in the study.
Key exclusion criteria (1 listed)
- Participants who are currently utilizing other services from Alternatives For Girls (AFG), children of AFG staff and youth participating in other sexual health education programs will not be eligible to participate and will be wait-listed until they are no longer receiving other services from AFG (i.e., after-school programs, summer day camps, mentoring, youth leadership programs, and shelter services). These services are unrelated to the study/sexual health education and do not include EmpowHer or Sassy Science. If siblings were to be enrolled, one would be randomly assigned, and the rest would be allowed to participate in the same group as the study sibling but not counted in the evaluation. This is to prevent possible contamination between conditions.
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 |
|---|---|---|
| The intervention curriculum addresses sexual activity, abstinence, and adulthood preparation topics.The intervention is youth-co-led, and targets youth in Detroit, Out-Wayne County or geographically similar areas through a 16-unit curriculum totaling 20 hours. Each participant and their parent/guardian will also receive one individual session with a case planner. Parents will receive 3 hours of parental support group. EmpowHer contains lessons and activities focusing on topics relating to abstinence, and teen pregnancy prevention, focusing on adulthood preparation subjects (APS), such as parent-child communication, adolescent development, healthy life skills, and healthy relationships. | Behavioural | EmpowHer |
Primary outcome
Recent sexual activity
Time frame: At 9-month follow up.
Do participants in the curriculum model (EmpowHer) show reduced rates of sexual activity at 9-month follow up compared to those in a control curriculum (Sassy Science)?
Abstinence
Time frame: At 9-month follow up.
Do participants in the curriculum model (EmpowHer) show increased rates of abstinence at (a) 6-month follow-up, and (b) 9-month follow up compared to those in control curriculum (Sassy Science)?
1 secondary outcome
Healthy relationship knowledge
Time frame: After 20-hour intervention (at post-test).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No. Not sharing.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The intervention curriculum addresses sexual activity, abstinence, and adulthood preparation topics. in people with Abstinence, Sex, 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: looking for participants now, as of the sponsor's last update on 14 Aug 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Celia Thomas, DHA (313-361-4000, cthomas@alternativesforgirls.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recent sexual activity (time frame: At 9-month follow up.). The study lists 2 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 14 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.