Evaluation of Are You Ready?

NCT ID: NCT06580080

Last Updated: 2025-11-12

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

1850 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-15

Study Completion Date

2028-09-14

Brief Summary

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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 21 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.

Detailed Description

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This is an individual-level, randomized control trial to rigorously evaluate the impact of the Are You Ready? (AYR) 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 (four months after baseline); and nine months post-intervention (ten 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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Are You Ready?

Group Type EXPERIMENTAL

Are You Ready? (AYR)

Intervention Type BEHAVIORAL

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.

Social Media Awareness Shorts

Group Type SHAM_COMPARATOR

Social Media Awareness Shorts (SMAS)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* At risk for or involved in the juvenile justice and/or child welfare systems
* Has had vaginal or anal sex in the past 6 months
* Comfortable reading, speaking, and writing in English

Exclusion Criteria

* Has received other known sexual and reproductive health evidence-based interventions implemented in their local area.
* Enrolled in an ongoing PRG-run TPP study
* Identified as fraudulent
Minimum Eligible Age

14 Years

Maximum Eligible Age

21 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

Reproductive Health National Training Center

UNKNOWN

Sponsor Role collaborator

Institute of Women & Ethnic Studies

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, PhD

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

Phone: 504.865.1545

Email: [email protected]

Elyse Mason, MPH

Role: CONTACT

Phone: 504.865.1545

Email: [email protected]

Facility Contacts

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Hilary Demby, MPH

Role: primary

Other Identifiers

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1 TP2AH000094-01-00

Identifier Type: -

Identifier Source: org_study_id