Are You Ready? for Teen Pregnancy Prevention

(AYR Trial)

Overseen By Hilary Demby, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: The Policy & Research Group

Disqualifiers: Other interventions

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

1850 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the "Are You Ready?" (AYR) program can improve sexual and mental health in teens and young adults involved with the juvenile justice or child welfare systems. The study will assess whether AYR aids in getting tested for sexually transmitted infections, using coping skills, and practicing safer sex. Participants will be divided into two groups: one receiving the AYR program and the other receiving a different program without sexual health information. The trial seeks participants who have engaged in vaginal or anal sex in the past three months and are comfortable using English. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance health programs for young people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Are You Ready? intervention is safe for youth?

Research shows that the "Are You Ready?" (AYR) program aims to improve the sexual and mental health of young people. This 2.5-hour session can be completed online or in person. It involves no medications or medical procedures, so it generally presents fewer safety concerns than drug trials.

Studies on similar programs for preventing teen pregnancy have shown positive results without major side effects. For instance, one study found that participants had lower pregnancy rates over 18 months and reported no significant safety issues.

Since AYR focuses on behavior through education, it is considered low-risk. Participants are likely to find it manageable, as it primarily involves discussions and learning activities. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about "Are You Ready?" (AYR) for teen pregnancy prevention because it takes a fresh approach by targeting teens through engaging social media content. Unlike traditional programs that often rely on in-person education sessions, AYR leverages the power of digital platforms to reach teens where they spend a lot of their time. This novel delivery method aims to raise awareness and influence behavior effectively, potentially offering a more accessible and scalable solution to prevent teen pregnancies.

What evidence suggests that the Are You Ready? intervention is effective for teen pregnancy prevention?

Research shows that programs like Are You Ready? (AYR), which participants in this trial may receive, positively impact teen sexual and mental health. Studies have found that these programs can help lower teen pregnancy rates and encourage better condom use. Participants often gain confidence in using birth control in the future. These programs also increase testing for sexually transmitted infections (STIs). Overall, evidence suggests that programs like AYR promote healthier sexual behaviors in teens. ^{5 6 7 8 9}

Who Is on the Research Team?

Sarah Walsh, PhD

Principal Investigator

The Policy & Research Group

Are You a Good Fit for This Trial?

This trial is for sexually active youth aged 14-21 who are at risk or involved with juvenile justice/child welfare systems, have had vaginal or anal sex in the past 3 months, and are comfortable with English. It's not specified who can't join.

Inclusion Criteria

At risk for or involved in the juvenile justice and/or child welfare systems

Comfortable reading, speaking, and writing in English

I have had vaginal or anal sex in the last 3 months.

Exclusion Criteria

I have received local sexual and reproductive health interventions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Are You Ready? (AYR) intervention as a virtual or in-person, 2.5-hour group session

1 session

1 visit (in-person or virtual)

Follow-up

Participants are monitored for changes in sexual and mental health behaviors, including STI testing, coping skills, and condom use

10 months

3 assessments (baseline, 4 months, 10 months post-baseline)

What Are the Treatments Tested in This Trial?

Interventions

• Are You Ready? (AYR)

Trial Overview The study tests if 'Are You Ready?' (AYR), a sexual and mental health program, affects STI testing rates, use of coping skills, and condomless sex frequency among participants compared to a control group without such information.

How Is the Trial Designed?

Group I: Are You Ready? Experimental Treatment 1 Intervention

Group II: Social Media Awareness Shorts Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

The Policy & Research Group

Lead Sponsor

Trials

12

Recruited

12,700+

Mathematica Policy Research, Inc.

Collaborator

Trials

68

Recruited

31,130,000+

Department of Health and Human Services Office of Population Affairs

Collaborator

Trials

4

Recruited

5,400+

Institute of Women & Ethnic Studies

Collaborator

Trials

1

Recruited

1,900+

Reproductive Health National Training Center

Collaborator

Trials

4

Recruited

5,400+

Department of Health and Human Services

Collaborator

Trials

240

Recruited

944,000+

Published Research Related to This Trial

A scoping review of 19 studies identified several factors associated with teen pregnancy in young men, including childhood abuse, delinquent behaviors, substance abuse, and family disruption, highlighting the need for targeted prevention programs.

The review revealed a lack of research on young men's knowledge of contraceptive methods and access to clinical services, suggesting that future studies should address these gaps to better understand and prevent teen pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Socioecological risk factors associated with teen pregnancy or birth for young men: A scoping review. Fasula, AM., Chia, V., Murray, CC., et al.[2020]

Adolescent pregnancy has significant negative effects on the physical, emotional, educational, and economic well-being of teenagers, with a notable percentage of pregnancies being unplanned and unwanted.

Preventing teenage pregnancy through comprehensive sex education and access to family planning resources is emphasized as a more effective approach than abortion, highlighting the need for clinicians to advocate for better educational programs and services for teenagers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adolescent pregnancy in the United States: a review and recommendations for clinicians and research needs. Fielding, JE., Williams, CA.[2005]

Teenage pregnancy is increasingly recognized as a significant social issue in the United States, prompting the need for effective prevention strategies.

The proposed comprehensive prevention program focuses on cognitive-behavioral training techniques to equip adolescents with the skills needed to prevent unwanted pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing unwanted adolescent pregnancy: a cognitive-behavioral approach. Schinke, SP., Gilchrist, LD., Small, RW.[2017]

A pilot study involving 52 predominantly college-bound 9th graders revealed that many girls were sexually active, with some having experienced pregnancy and others at risk for intentional pregnancy, highlighting a need for targeted interventions in this demographic.

The study found that knowledge about pregnancy prevention was only modest among participants, suggesting that school-based and peer-focused programs could be effective strategies to improve awareness and reduce teenage pregnancy rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge, attitudes, and behavior related to pregnancy in a rural teenage population. Carter, KF., Spear, HJ.[2015]

A community assessment involving 25 stakeholder interviews revealed that while there is recognition of teen pregnancy as a significant issue, stakeholders lack sufficient contextual information and data to effectively address it.

Although many stakeholders expressed readiness to engage in prevention efforts, they identified a need for additional training and information to enhance their capacity to implement the Youth First initiative successfully.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies to Build Readiness in Community Mobilization Efforts for Implementation in a Multi-Year Teen Pregnancy Prevention Initiative. Bhuiya, N., House, LD., Desmarais, J., et al.[2020]

Citations

1. withpower.com withpower.com/trial/phase-teen-pregnancy-prevention-8-2024-dfa8a

Are You Ready? for Teen Pregnancy Prevention (AYR Trial) 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 ...

2. opa.hhs.gov opa.hhs.gov/research-evaluation/teen-pregnancy-prevention-program-evaluations/summary-programs-effective-changing-behavior

Summary of Evaluated Programs Effective at Changing Behavior The programs described below were found effective at changing the behavior of program participants. The OAH Teen Pregnancy Prevention (TPP) Program evaluated ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33433926/

The Effectiveness of a Teen Outreach Pregnancy ... Other positive changes noted were that students felt empowered to use condoms, other barriers, or birth control in the future when having sexual ...

4. abtglobal.com abtglobal.com/projects/teen-pregnancy-prevention-study-finds-benefits

Teen Pregnancy Prevention Study Finds Benefits The program had a promising effect on reducing pregnancy over the 18 month period. Compared to non-participants, program participants also reported improvements ...

5. acf.gov acf.gov/opre/report/evaluating-teen-pregnancy-prevention-program-risk-youth-alternative-schools

Evaluating a Teen Pregnancy Prevention Program for At- ... This brief highlights evidence on the impacts of the Teen Choice curriculum for youth in alternative schools in and around New York City.

6. opa.hhs.gov opa.hhs.gov/research-evaluation/teen-pregnancy-prevention-program-evaluations/tpp-evidence-review

Updated Findings from the HHS Teen Pregnancy Prevention ... The HHS Teen Pregnancy Prevention Evidence Review (TPPER) provides the results of the systematic review, and was created in response to the Congressional ...

7. who.int who.int/news-room/fact-sheets/detail/adolescent-pregnancy

Adolescent pregnancy Adolescent mothers (aged 10–19 years) face higher risks of eclampsia, puerperal endometritis and systemic infections than women aged 20–24 years ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7567553/

Perspectives on Adolescent Pregnancy Prevention Strategies ... This review article summarizes trends and strategies around adolescent pregnancy prevention, provides lessons learned and best practices, and presents ideas ...

9. cdc.gov cdc.gov/reproductive-health/teen-pregnancy/index.html

About Teen Pregnancy | Reproductive Health Information on teen pregnancy rates and birth data in U.S. and what CDC is doing.