Gender-based ViolenceEYPNCT06576193
Empowering Young Parents: Building Healthy Relationships Study
A study testing Safe Dates for Young Parents (SDYP) in people with Gender-based Violence and Intimate Partner Violence, run by RTI International at 12 sites in United States.
Trial summary
The goal of this trial is to learn how the Safe Dates for Young Parents (SDYP) intervention affects the sexual and reproductive health behaviors, and quality of, and attitudes surrounding intimate partner relationships in adolescents and young adults (AYA) assigned female sex at birth who are pregnant or parenting. Read more about this study
- Who is it for?
- Ages 14 to 21 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gender-based Violence, Intimate Partner Violence
- What is being tested?
- Safe Dates for Young Parents (SDYP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 12 sitesUnited States
- Study dates
- 16 Oct 2024to Aug 2028
- 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 14 to 21 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescent and Young Adult (AYA) [EYP study participants]
- Aged 14-21 years (inclusive) at Screening.
- Assigned female sex at birth.
- Currently pregnant or parenting their child who lives with them at least part-time.
- Able to speak and read English or Spanish.
- Able and willing to provide verbal informed consent for enrollment in the EYP study.
Show all 13Show fewer
- Able and willing to provide adequate contact/locator information.
- Able and willing to complete protocol requirements, including completion of three study interviews over one year.
- Study Facilitators (process evaluation participants)
- Aged 18 years or older.
- Trained and served as a facilitator of the SDYP intervention.
- Able to speak and read English.
- Able and willing to provide verbal informed consent.
Who cannot join
- Per participant report at Screening or Enrollment, intends to travel away from their geographic area of residence for a time period that would interfere with study participation, including with intervention participation should the participant be randomized to the SDYP intervention.
- Has any other condition that, in the opinion of the Principal Investigator (PI) or their designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites, 7 recruiting
- Completed
GCAPP and Communities In Schools of Albany/Dougherty
Albany, Georgia, 31701
- Completed
GCAPP and Covenant House Georgia
Atlanta, Georgia, 30318
- Recruiting
Berrien County Health Department
Benton Harbor, Michigan, 49022
Miranda Dopp, 269-927-5635, mdopp@bchdmi.org
- Recruiting
Delaware Adolescent Program, Inc. (DAPI) - Kent County
Camden, Delaware, 19934
Maleka Pettyjohn, 302-697-0356, mpettyjohn@dapi.org
- Completed
Eaton Regional Education Service Agency (RESA)
Charlotte, Michigan, 48813
- Recruiting
Pathways Academy
Detroit, Michigan, 48214
Debra Meadows, 313-209-3804, DMeadows@pathwaysdetroit.com
- Recruiting
Delaware Adolescent Program, Inc. (DAPI) - Sussex County
Georgetown, Delaware, 19947
Kim Wright, 302-722-2261, kwright@dapi.org
- Completed
The Exchange Club
Graham, North Carolina, 27253
- Completed
Children & Family Resource Center
Hendersonville, North Carolina, 28792
- Recruiting
Saginaw Intermediate School District
Saginaw, Michigan, 48601
Rosa Davis, 989-399-7453, rdavis@sisd.cc
- Recruiting
Empowering Connections, Partnership for Children & Families
Sanford, North Carolina, 27330
Cristal Avalos, 919-774-9496, empoweryounc@gmail.com
- Recruiting
Healthy Generations Program at Children's National Hospital
Washington D.C., District of Columbia, 20020
Yael Smiley, 202-476-2123, YTSmiley@childrensnational.org
About this study
Official title: Empowering Young Parents: Building Health Relationships Study Evaluation of the Safe Dates for Young Parents Intervention
The goal of this trial is to learn how the Safe Dates for Young Parents (SDYP) intervention affects the sexual and reproductive health behaviors, and quality of, and attitudes surrounding intimate partner relationships in adolescents and young adults (AYA) assigned female sex at birth who are pregnant or parenting.
The main questions it aims to answer are:
Read more
- Will the SDYP intervention have any effect on the sexual and reproductive health behaviors during the study period?
- Will the SDYP intervention have any effect on the prevention or reduction of intimate partner violence (IPV)?
- Will the SDYP intervention have any effect on the attitudes and beliefs about healthy relationships?
Researchers will compare the behaviors, attitudes, and beliefs about sexual and reproductive health and relationships of participants assigned to the SDYP intervention group to participants assigned to the control (non-SDYP intervention) group to see if there is any difference or changes in those behaviors, attitudes, and beliefs before-and-after or without the SDYP intervention.
Participants in the SDYP intervention will attend ten (10) 50-minute group sessions that will involve interactive discussions, thinking through life-like scenarios, games, role-plays, brainstorming, and a poster contest and theatrical play.
- Conditions
- Gender-based Violence, Intimate Partner Violence
- Being tested
- Safe Dates for Young Parents (SDYP)
- Keywords
- Young Adult Parents, Adolescent Pregnancy, Adolescent Parents, Healthy Relationships
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe Dates for Young Parents (SDYP)Behavioural
SDYP is a healthy relationship and intimate partner violence (IPV) prevention program, adapted from "Safe Dates (Foshee et al., 1998; Foshee et al., 1996)" designed for teens, that focuses on pregnant or parenting females. The program consists of ten group-based sessions (50 minutes each) led by a trained facilitator which include interactive discussions, analysis of scenarios, games, role-plays, brainstorming, and a poster contest and theatrical play.
| Study group | Role | What they receive |
|---|---|---|
| Safe Dates for Young Parents (SDYP) | Experimental | Participants will receive and complete SDYP intervention activities focused on healthy relationships and intimate partner violence (IPV) prevention plus standard services offered at the study site. Receives: Behavioral: Safe Dates for Young Parents (SDYP) |
| Standard Services Only | No intervention | Participants will only receive standard-of-care programming that typically includes services such as one-on-one strength-based case management and comprehensive sex education. The standard services will not address IPV or healthy relationships content that composes the SDYP intervention. Referrals to additional services will be offered to all participants, as needed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Condomless vaginal or anal sex (Month 12)
Participant-reported condom use at recalled instances of vaginal or anal sex over the past 3 months and at 12 months follow-up using a standard, self-administered questionnaire.
Measured: Three months, Twelve months
Secondary outcomes (5)
Condomless vaginal or anal sex (Month 6)
Participant-reported condom use at recalled instances of vaginal or anal sex over the past 3 months and at 6 months follow-up visit using a standard, self-administered questionnaire.
Measured: Three months, Six months
Sexual and Reproductive Coercion
Participant-reported occurrence of sexual and reproductive coercion with their primary or recent sexual partner at study Month 12 using a 5-point Likert scale questionnaire.
Measured: Month 12
Negotiation of condom use and contraception
Participant-reported ability to successfully negotiate condom and contraceptive-use with their primary or recent sexual partner at study Month 6 using 5- and 4-point Likert scale self-administered questionnaires.
Measured: Month 6
Intimate Partner Violence (IPV)
Participant-reported history, frequency, and severity of IPV (physical and psychological) at study Month 12 using polar (Yes/No), 5- and 4-point Likert scale self-administered questionnaires.
Measured: Month 12
Healthy relationship attitudes, beliefs, and behaviors
Participant-reported attitudes, beliefs, and behaviors about healthy relationships (conflict management skills and emotion regulation) for themselves, their families, or in general at study Month 6 using 5- and 4-point Likert scale self-administered questionnaires.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start16 Oct 2024
- Primary completionMar 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender-based ViolenceStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individual AYA will be block-randomized to the SDYP intervention with standard prenatal and post-partum services (intervention condition) or standard services only (control condition) using a 1:1 allocation within each site (stratified randomization) to ensure balanced assignment, using permuted blocks sizes of 4 and 6.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marni Kan, PhD, Study director, RTI InternationalAlexandra Minnis, PhD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576193
- Sponsor's protocol ID
- TP2AH000082
- Acronym
- EYP
- Status last verified
- Oct 2025
- First submitted
- 23 Aug 2024
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Young Parents: Building Health Relationships Study Evaluation of the Safe Dates for Young Parents Intervention
- ClinicalTrials.gov ID
- NCT06576193
- Acronym / sponsor ID
- EYP / TP2AH000082
- Conditions
- Gender-based Violence, Intimate Partner Violence
- Keywords
- Young Adult Parents, Adolescent Pregnancy, Adolescent Parents, Healthy Relationships
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 28 Aug 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.
The goal of this trial is to learn how the Safe Dates for Young Parents (SDYP) intervention affects the sexual and reproductive health behaviors, and quality of, and attitudes surrounding intimate partner relationships in adolescents and young adults (AYA) assigned female sex at birth who are pregnant or parenting.
The main questions it aims to answer are:
- Will the SDYP intervention have any effect on the sexual and reproductive health behaviors during the study period?
- Will the SDYP intervention have any effect on the prevention or reduction of intimate partner violence (IPV)?
- Will the SDYP intervention have any effect on the attitudes and beliefs about healthy relationships?
Researchers will compare the behaviors, attitudes, and beliefs about sexual and reproductive health and relationships of participants assigned to the SDYP intervention group to participants assigned to the control (non-SDYP intervention) group to see if there is any difference or changes in those behaviors, attitudes, and beliefs before-and-after or without the SDYP intervention.
Participants in the SDYP intervention will attend ten (10) 50-minute group sessions that will involve interactive discussions, thinking through life-like scenarios, games, role-plays, brainstorming, and a poster contest and theatrical play.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Individual AYA will be block-randomized to the SDYP intervention with standard prenatal and post-partum services (intervention condition) or standard services only (control condition) using a 1:1 allocation within each site (stratified randomization) to ensure balanced assignment, using permuted blocks sizes of 4 and 6.
| Arm | Type | Receives |
|---|---|---|
| Safe Dates for Young Parents (SDYP) | Experimental | Behavioral: Safe Dates for Young Parents (SDYP)Participants will receive and complete SDYP intervention activities focused on healthy relationships and intimate partner violence (IPV) prevention plus standard services offered at the study site. |
| Standard Services Only | No intervention | –Participants will only receive standard-of-care programming that typically includes services such as one-on-one strength-based case management and comprehensive sex education. The standard services will not address IPV or healthy relationships content that composes the SDYP intervention. Referrals to additional services will be offered to all participants, as needed. |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Adolescent and Young Adult (AYA) [EYP study participants]
- Aged 14-21 years (inclusive) at Screening.
- Assigned female sex at birth.
- Currently pregnant or parenting their child who lives with them at least part-time.
- Able to speak and read English or Spanish.
Key exclusion criteria (2 listed)
- Per participant report at Screening or Enrollment, intends to travel away from their geographic area of residence for a time period that would interfere with study participation, including with intervention participation should the participant be randomized to the SDYP intervention.
- Has any other condition that, in the opinion of the Principal Investigator (PI) or their designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
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 |
|---|---|---|
| Safe Dates for Young Parents (SDYP)SDYP is a healthy relationship and intimate partner violence (IPV) prevention program, adapted from "Safe Dates (Foshee et al., 1998; Foshee et al., 1996)" designed for teens, that focuses on pregnant or parenting females. The program consists of ten group-based sessions (50 minutes each) led by a trained facilitator which include interactive discussions, analysis of scenarios, games, role-plays, brainstorming, and a poster contest and theatrical play. | Behavioural | Safe Dates for Young Parents (SDYP) |
Primary outcome
Condomless vaginal or anal sex (Month 12)
Time frame: Three months, Twelve months
Participant-reported condom use at recalled instances of vaginal or anal sex over the past 3 months and at 12 months follow-up using a standard, self-administered questionnaire.
5 secondary outcomes
Condomless vaginal or anal sex (Month 6)
Time frame: Three months, Six months
Sexual and Reproductive Coercion
Time frame: Month 12
Negotiation of condom use and contraception
Time frame: Month 6
Intimate Partner Violence (IPV)
Time frame: Month 12
Healthy relationship attitudes, beliefs, and behaviors
Time frame: Month 6
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 30 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Gender-based Violence
Not yet recruiting
Group Cognitive Processing Therapy for Women Survivors of Gender-Based Violence: Feasibility Study
Trauma, Psychological, Traumatic Stress Disorder
Not yet recruiting
Comparison of Escape Room and Branching Scenario Games in Nursing Education
Gender Prediction, Dating Violence
RecruitingObservational study
Evaluation of the Impact on Mental and Physical Health of Caring for Women Who Are Victims of Sexual and Gender-based Violence, Using a Coordinated Multidisciplinary Approach in Women's Centres or Traditional Health Centres.
Domestic and/or Sexual Violence
Active, not recruiting
Mpata Yathu Trial for Young Women in Zambia
HIV, Common Mental Health Problems
Active, not recruiting
Pathways to Improved Adolescent Mental Health in Conflict Affected Families
Mental Health Issue, Gender Equality
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.
Marni Kan, PhD study director
RTI International
Alexandra Minnis, PhD principal investigator
RTI International
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safe Dates for Young Parents (SDYP) in people with Gender-based Violence and Intimate Partner Violence, run by RTI International at 12 sites 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 13 inclusion and 2 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 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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 Marni Kan, PhD (919-485-2756, mkan@rti.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Condomless vaginal or anal sex (Month 12) (time frame: Three months, Twelve months). 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 30 Oct 2025.