Clinical trial NCT06576193: Empowering Young Parents: Building Healthy Relationships Study
Official title: Empowering Young Parents: Building Health Relationships Study Evaluation of the Safe Dates for Young Parents Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gender-based Violence
Intimate Partner Violence
Keywords: Young Adult Parents
Adolescent Pregnancy
Adolescent Parents
Healthy Relationships
Lead sponsor: RTI International
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 600
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

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.
* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Condomless vaginal or anal sex (Month 12)
timeFrame: Three months, Twelve months
Secondary outcomes:
measure: Condomless vaginal or anal sex (Month 6)
timeFrame: Three months, Six months
measure: Sexual and Reproductive Coercion
timeFrame: Month 12
measure: Negotiation of condom use and contraception
timeFrame: Month 6
measure: Intimate Partner Violence (IPV)
timeFrame: Month 12
measure: Healthy relationship attitudes, beliefs, and behaviors
timeFrame: Month 6
Other outcomes:
Locations:
city: Albany
country: United States
facility: GCAPP and Communities In Schools of Albany/Dougherty
state: Georgia
city: Atlanta
country: United States
facility: GCAPP and Covenant House Georgia
state: Georgia
city: Charlotte
country: United States
facility: Eaton Regional Education Service Agency (RESA)
state: Michigan
city: Detroit
country: United States
facility: Pathways Academy
state: Michigan
city: Graham
country: United States
facility: The Exchange Club
state: North Carolina
city: Sanford
country: United States
facility: Empowering Connections, Partnership for Children & Families
state: North Carolina
Study officials:
affiliation: RTI International
name: Marni Kan, PhD
role: STUDY_DIRECTOR
affiliation: RTI International
name: Alexandra Minnis, PhD
role: PRINCIPAL_INVESTIGATOR
References: