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RecruitingNCT06574217StStUpdated May 13, 2026

Evaluation of Stepping Stones

An interventional study of Stepping Stones (StSt) and Like in Teen Pregnancy Prevention, sponsored by The Policy & Research Group. Recruiting at 1 site in United States. Open to participants aged 12 Years to 22 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-13.

Sponsored by The Policy & Research Group · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
650
Allocation
Randomized
Ages
12 Years to 22 Years
Sex
All
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Study 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.

Read the 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).

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Conditions studied

  • Teen Pregnancy Prevention
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In context

Lead sponsor

The Policy & Research Group is the lead sponsor of 12 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 22 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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)
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
650 participants (estimated)

Study arms

  • Experimental
    Stepping Stones

    Behavioral: Stepping Stones (StSt)

  • Sham comparator
    Like

    Behavioral: Like

Interventions

  • BehavioralStepping 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.

  • BehavioralLike

    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.

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What researchers measure

Primary outcomes

  1. Receipt of sexually transmitted infection (STI) testing in the past four months

    Participants are asked the following item: 1\) Have you been tested for sexually transmitted infections (STIs) in the past 4 months? The resulting variable is dichotomous with values 0 or 1, where 0 indicates a person who has not received STI testing in the past four months and 1 indicates a person who has received STI testing in the past four months.

    Time frame: Assessed three months after the intervention period has ended (five months post-baseline)

  2. Times having vaginal and anal sex without condoms in the past four months

    Participants are asked the following two items: 1. In the past 4 months, how many times have you had vaginal sex without you or your sexual partner using a condom? 2. In the past 4 months, how many times have you had anal sex without you or your sexual partner using a condom? The resulting variable is continuous with values that range from 0 to k, where 0 indicates that a person has not engaged in vaginal and anal sex without a condom in the past four months, and k indicates the number of times the person has engaged in vaginal and anal sex without a condom in the past four months.

    Time frame: Assessed nine months after the intervention period has ended (eleven months post-baseline)

  3. Perpetration of emotional abuse

    Participants are asked how many times in the past four months they have done the following things to a sexual or romantic partner: 1. Damaged something on purpose that belonged to them? 2. Said things to hurt their feelings on purpose? 3. Insulted them in front of others? 4. Would not let them talk to or do things with other people? 5. Threatened to start dating someone else? 6. Did something just to make them jealous? 7. Blamed them for bad things you did? 8. Threatened to hurt them? 9. Made them report where they were every minute of the day? 10. Put down their looks? 11. Threw something at them but missed? 12. Told them they could not talk to someone else? 13. Started to hit them but stopped? 14. Brought up something from the past to hurt them? Participants are provided with four response options: 0 times; 1 to 3 times; 4 to 9 times; or 10 or more times. The measure is calculated as the average response to all 14 items in the scale.

    Time frame: Assessed nine months after the intervention period has ended (eleven months post-baseline)

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Study locations

1 of 1 sites recruiting
  • The Policy & Research Group
    New Orleans, Louisiana 70118, United States
    Recruiting
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References and documents

Individual participant data

Plan to share: Yes — A dataset will be prepared at the conclusion of the study, which includes deidentified individual-level data on all study participants who contributed self report data. Respondents will be represented only by a research ID number. Included in the dataset will be self-report data collected across all survey administrations (including demographic characteristics, sexual behaviors, and theoretical antecedents to those behaviors) and select information on program participation (e.g., which program components were completed). Basic data cleaning steps will be taken in order to ensure data are unidentifiable and to increase usability.

Supporting information: Sap

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06574217
Lead sponsor
The Policy & Research Group
Collaborators
Department of Health and Human Services, Mathematica Policy Research, Inc., Public Health - Seattle and King County, Reproductive Health National Training Center
Responsible party
Sponsor
First posted
Aug 27, 2024
Start date
Sep 16, 2024
Primary completion
Mar 2028 (estimated)
Completion
Sep 14, 2028 (estimated)
Last update
May 13, 2026

Study contacts

Hilary Demby, MPH
Contact
hilary@policyandresearch.com
504-865-545
Kelly Burgess, MPH
Contact
kelly@policyandresearch.com
504-865-545
Sarah Walsh, Ph.D.
principal investigator · The Policy & Research Group

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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