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Recruiting NCT06580080

Evaluation of Are You Ready?

No phase Interventional Teen Pregnancy Prevention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Are You Ready? (AYR), Social Media Awareness Shorts (SMAS).
Who it may be relevant to
Registry conditions: Teen Pregnancy Prevention. Basic parameters: 14 years — 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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).

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. T
  • 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.

Primary outcome measures

  • Receipt of sexually transmitted infection (STI) testing in the past three months [Time frame: Assessed three months after the intervention period has ended (four months post-baseline)]
  • Use of coping skills [Time frame: Assessed three months after the intervention period has ended (four months post-baseline)]
  • Times having vaginal and anal sex without condoms in the past three months [Time frame: Assessed nine months after the intervention period has ended (ten months post-baseline)]

Eligibility criteria

Inclusion criteria

  • At risk for or involved in the juvenile justice and/or child welfare systems
  • Has had vaginal or anal sex in the last 6 months or has ever had vaginal or anal sex and self-report likelihood of having sex in the next 6 months
  • Comfortable reading, speaking, and writing in English
  • United States resident

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • The Policy & Research Group — New Orleans

Identifiers

NCT: NCT06580080 · 1 TP2AH000094-01-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗