- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06217809
EmpowHer is Prevention Curriculum for Youth Ages 10-15 Years.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Celia Thomas, DHA
- Phone Number: 313-361-4000
- Email: cthomas@alternativesforgirls.org
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48208
- Recruiting
- Alternatives For Girls
-
Contact:
- Jonquil Bertschi, JD
- Phone Number: 3133614000
- Email: jbertschi@alternativesforgirls.org
-
Contact:
- Celia Thomas, MPA
- Phone Number: 226 3133614000
- Email: cthomas@alternativesforgirls.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: EmpowHer
The intervention curriculum is designed to address 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)?
|
At 9-month follow up.
|
|
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)?
|
At 9-month follow up.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Healthy relationship knowledge
Time Frame: After 20-hour intervention (at post-test).
|
Do participants in the curriculum model (EmpowHer) show increased healthy relationship knowledge at post-test compared to those in a control curriculum (Sassy Science)?
|
After 20-hour intervention (at post-test).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EmpowHer
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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