NCT06217809

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
552

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Feb 2022Sep 2026

Study Start

First participant enrolled

February 22, 2022

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Expected
Last Updated

August 14, 2025

Status Verified

August 1, 2025

Enrollment Period

3.9 years

First QC Date

December 28, 2023

Last Update Submit

August 11, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)?

    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)?

    At 9-month follow up.

Secondary Outcomes (1)

  • Healthy relationship knowledge

    After 20-hour intervention (at post-test).

Study Arms (1)

EmpowHer

EXPERIMENTAL

The intervention curriculum is designed to address abstinence, and adulthood preparation topics.

Behavioral: The intervention curriculum addresses sexual activity, abstinence, and adulthood preparation topics.

Interventions

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.

EmpowHer

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alternatives For Girls

Detroit, Michigan, 48208, United States

RECRUITING

MeSH Terms

Conditions

Sexual Abstinence

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 28, 2023

First Posted

January 23, 2024

Study Start

February 22, 2022

Primary Completion

January 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

August 14, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Not sharing.

Locations