Evaluation of Are You Ready?

NCT06580080 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1850

Last updated 2026-04-24

No results posted yet for this study

Summary

The goal of this randomized trial is to learn if the Are You Ready? (AYR) intervention has a positive impact on the sexual and mental health behaviors of sexually active youth between the ages of 14 and 22 years old who are at risk for or involved in the juvenile justice and/or child welfare systems. The primary research questions it aims to answer are:

* Three months after being offered the intervention, does AYR impact youth's receipt of sexually transmitted infection testing in the past three months?
* Three months after being offered the intervention, does AYR impact youth's use of coping skills?
* Nine months after being offered the intervention, does AYR impact youth's frequency of having vaginal and anal sex without condoms in the past three months?

Researchers will compare participants randomized to receive AYR (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 AYR as a virtual or in-person, 2.5 hour group session. Participants randomized to the control group will be offered a virtually delivered control condition.

Conditions

  • Teen Pregnancy Prevention

Interventions

BEHAVIORAL

Are You Ready? (AYR)

AYR is a group-based entertainment education (EE) intervention designed for sexually active youth who are at risk for or involved in the juvenile justice and/or child welfare systems. AYR is delivered in one, 2.5-hour (150-minute) session with a group of between 2 to 20 youth. The session includes screening a 40-minute video, "Happy Birthday, Leonard" and group-based discussions led by one to two facilitators. Discussions are guided by a participant workbook with journal prompts and handouts. The session includes two modules; each module involves screening approximately 20 minutes of "Happy Birthday, Leonard" followed by a 40-minute group discussion. Module 1 includes topics related to contraception, condom use (with a condom demonstration), healthy communication, and stress management. Module 2 includes topics related to condom negotiation, communication styles, and intergenerational cycles.

BEHAVIORAL

Social Media Awareness Shorts (SMAS)

SMAS is a virtually delivered, individual-based health program focused on social media use awareness. Participants are directed to a learning management platform that contains a pre-recorded, facilitated program. The program involves watching several short films and independently completing several activities related to social media use. The program does not include information related to the primary outcomes for this study.

Sponsors & Collaborators

  • Department of Health and Human Services

    collaborator FED
  • Mathematica Policy Research, Inc.

    collaborator OTHER
  • Reproductive Health National Training Center

    collaborator UNKNOWN
  • Institute of Women & Ethnic Studies

    collaborator UNKNOWN
  • The Policy & Research Group

    lead OTHER

Principal Investigators

  • Sarah Walsh, PhD · The Policy & Research Group

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-15
Primary Completion
2028-08-31
Completion
2028-09-14

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06580080 on ClinicalTrials.gov