Evaluation of Stepping Stones

NCT ID: NCT06574217

Last Updated: 2025-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-16

Study Completion Date

2028-09-14

Brief Summary

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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

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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).

Conditions

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Teen Pregnancy Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Stepping Stones

Group Type EXPERIMENTAL

Stepping Stones (StSt)

Intervention Type BEHAVIORAL

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.

Like

Group Type SHAM_COMPARATOR

Like

Intervention Type BEHAVIORAL

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.

Interventions

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Stepping Stones (StSt)

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
* Identified as fraudulent (only for individuals recruited online)
Minimum Eligible Age

12 Years

Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Department of Health and Human Services

FED

Sponsor Role collaborator

Mathematica Policy Research, Inc.

OTHER

Sponsor Role collaborator

Public Health - Seattle and King County

OTHER_GOV

Sponsor Role collaborator

Reproductive Health National Training Center

UNKNOWN

Sponsor Role collaborator

The Policy & Research Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah Walsh, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The Policy & Research Group

Locations

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The Policy & Research Group

New Orleans, Louisiana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Hilary Demby, MPH

Role: CONTACT

504-865-545

Kelly Burgess, MPH

Role: CONTACT

504-865-545

Facility Contacts

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Hilary Demby, MPH

Role: primary

504-865-1545

Other Identifiers

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1 TP2AH000093-01-00

Identifier Type: -

Identifier Source: org_study_id

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