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Recruiting NCT06574217

Evaluation of Stepping Stones

No phase Interventional Teen Pregnancy Prevention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stepping Stones (StSt), Like.
Who it may be relevant to
Registry conditions: Teen Pregnancy Prevention. Basic parameters: 12 years — 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

This is an individual-level, randomized control trial to rigorously evaluate the impact of the Stepping Stones (StSt) intervention. Participant outcomes will be assessed using self-reported, individual-level data gathered using a structured questionnaire administered at three time points: baseline (enrollment); three months post-intervention (five months after baseline); and nine months post-intervention (eleven months after baseline).

Interventions

  • Behavioral 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.
  • Behavioral 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 measures

  • 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)]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • The Policy & Research Group — New Orleans

Identifiers

NCT: NCT06574217 · 1 TP2AH000093-01-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗