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?

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.

Will I have to stop taking my current medications?

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

How is the 'Are You Ready?' treatment different from other teen pregnancy prevention methods?

The 'Are You Ready?' treatment is unique because it focuses on both young men and women, addressing the often-overlooked prevention needs of young men, and emphasizes community readiness and involvement, which is not typically a focus in standard teen pregnancy prevention programs. ^{1 2 3 4 5}

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]

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]

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]

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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Socioecological risk factors associated with teen pregnancy or birth for young men: A scoping review. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. Netherlands pubmed.ncbi.nlm.nih.gov

Adolescent pregnancy in the United States: a review and recommendations for clinicians and research needs. [2005]

4. United States pubmed.ncbi.nlm.nih.gov

Strategies to Build Readiness in Community Mobilization Efforts for Implementation in a Multi-Year Teen Pregnancy Prevention Initiative. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Preventing unwanted adolescent pregnancy: a cognitive-behavioral approach. [2017]