Evaluation of Stepping Stones

Not Applicable

Recruiting

• Conditions: Teen Pregnancy Prevention
• Interventions: Behavioral: Like; Behavioral: Stepping Stones (StSt)

• Registration Number: NCT06574217
• Lead Sponsor: The Policy & Research Group

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.

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).

Study Timeline

• Study First Submitted: 2024-08-23
• Study First Submitted QC: 2024-08-23
• Study First Posted: 2024-08-27
• Study Start: 2024-09-16
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-18
• Primary Completion: 2028-03
• Study Completion: 2028-09-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

• At risk for or involved in the legal or child welfare systems
• Has had vaginal or anal sex in the past 3 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Like	Like	-
Stepping Stones	Stepping Stones (StSt)	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

The Policy & Research Group; 🇺🇸 New Orleans, Louisiana, United States