Clinical trial NCT06574217: Evaluation of Stepping Stones
Official title: Evaluation of Stepping Stones
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Teen Pregnancy Prevention
Lead sponsor: The Policy & Research Group
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
name: Mathematica Policy Research, Inc.
name: Public Health - Seattle and King County
name: Reproductive Health National Training Center
First posted: 2024-08-27
Enrollment: 650
Sex: ALL
Minimum age (years): 12
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Receipt of sexually transmitted infection (STI) testing in the past four months
timeFrame: Assessed three months after the intervention period has ended (five months post-baseline)
measure: Times having vaginal and anal sex without condoms in the past four months
timeFrame: Assessed nine months after the intervention period has ended (eleven months post-baseline)
measure: Perpetration of emotional abuse
timeFrame: Assessed nine months after the intervention period has ended (eleven months post-baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: The Policy & Research Group
state: Louisiana
Study officials:
affiliation: The Policy & Research Group
name: Sarah Walsh, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: