Recruiting

Observational Study

Sponsor:

The Policy & Research Group

Code:

NCT06574217

Conditions

Teen Pregnancy Prevention

Eligibility Criteria

Sex: All

Age: 12 - 22

Healthy Volunteers: Accepted

Interventions

Stepping Stones (StSt)

Like

Study Details

Brief summary:

The goal of this randomized trial is to learn if the Stepping Stones (StSt) intervention has a positive impact on the sexual health and relationship behaviors of sexually active youth between the ages of 12 and 22 years old who are at risk for or involved in the legal or child welfare systems. The primary research questions it aims to answer are:

  • Three months after being offered the intervention, does StSt impact youth's receipt of sexually transmitted infection testing in the past four months?
  • Nine months after being offered the intervention, does StSt impact youth's frequency of having vaginal and anal sex without condoms in the past four months?
  • Nine months after being offered the intervention, does StSt impact youth's perpetration of emotional abuse in the past four months?

Researchers will compare participants randomized to receive StSt (treatment group) to participants randomized to receive a control condition that contains no sexual or reproductive health information (control group).

Participants randomized to the treatment group will be offered StSt as an in-person or virtual, individual-based intervention delivered over four sessions during a 6-8 week period. Participants randomized to the control group will be offered a virtually delivered control condition.

Conditions

Teen Pregnancy Prevention

Study ID

NCT06574217

Start date

Sep 16, 2024

Status verified date

May, 2026

Completion date

Sep 14, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 22

Healthy Volunteers: Accepted

Inclusion Criteria:

  • At risk for or involved in the legal or child welfare systems
  • Report ever having vaginal and/or anal sex and plan to have sex in the next six months
  • Comfortable reading, speaking, and writing in English

Exclusion Criteria:

  • Currently trying to start a pregnancy
  • Currently in jail or being detained in a facility
  • Enrolled in an ongoing PRG-run TPP study, the No Baby No study, or the Yes \& Know study
  • Living in regions where the FLASH curriculum is widely implemented (King County, WA, Ramsey County, MN, Hennepin County, MN)
  • Identified as fraudulent (only for individuals recruited online)

Study Design

Enrollment

650 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Stepping Stones

sham comparator: Like

Interventions

Stepping Stones (StSt)

StSt is an individual-level intervention designed to help youth make healthy decisions. StSt is delivered in-person or virtually by an adult guide during four \~30-50 minute sessions over a period of up to 8 weeks. The adult guide leads the youth through health-focused discussions related to identifying personal values, making a social network map, and then creating and refining individualized plans.

Like

Like is an hour-long film that discusses the impact of social media on the brain. Study staff will organize for each individual participant to watch the film in-person. The film does not include information related to the outcomes of interest for the study.

Primary outcome measure

  • Receipt of sexually transmitted infection (STI) testing in the past four months [ Time Frame: Assessed three months after the intervention period has ended (five months post-baseline) ]
  • Times having vaginal and anal sex without condoms in the past four months [ Time Frame: Assessed nine months after the intervention period has ended (eleven months post-baseline) ]
  • Perpetration of emotional abuse [ Time Frame: Assessed nine months after the intervention period has ended (eleven months post-baseline) ]

Central Contacts and Locations

Locations

The Policy & Research Group

Recruiting

New Orleans, Louisiana, United States, 70118

Contacts

More Information

Sponsor

The Policy & Research Group

Last update posted

May 13, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Policy & Research Group on 2026-05-13.