Evaluation of Stepping Stones
StSt
1 other identifier
interventional
650
1 country
1
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-person, 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2024
CompletedFirst Posted
Study publicly available on registry
August 27, 2024
CompletedStudy Start
First participant enrolled
September 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 14, 2028
December 9, 2025
December 1, 2025
3.5 years
August 23, 2024
December 2, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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.
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
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.
Assessed nine months after the intervention period has ended (eleven months post-baseline)
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.
Assessed nine months after the intervention period has ended (eleven months post-baseline)
Study Arms (2)
Stepping Stones
EXPERIMENTALLike
SHAM COMPARATORInterventions
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.
StSt is an individual-level intervention designed to help youth make healthy decisions. StSt is delivered in-person 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Currently trying to start a pregnancy
- Currently in jail or being detained in a facility
- Enrolled in an ongoing PRG-run TPP study
- Identified as fraudulent (only for individuals recruited online)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Policy & Research Grouplead
- Department of Health and Human Servicescollaborator
- Mathematica Policy Research, Inc.collaborator
- Public Health - Seattle and King Countycollaborator
- Reproductive Health National Training Centercollaborator
Study Sites (1)
The Policy & Research Group
New Orleans, Louisiana, 70118, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah Walsh, Ph.D.
The Policy & Research Group
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2024
First Posted
August 27, 2024
Study Start
September 16, 2024
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
September 14, 2028
Last Updated
December 9, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP
- Time Frame
- The individual participant dataset will become available twelve months after the study has concluded.
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.