Adolescent Pregnancy Prevention Programs for Reproductive Health

Overseen By Cindy Walker, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Trinity Church Inc.

Disqualifiers: Non-consent, Pilot study, Previous cohort, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate two programs designed to reduce unprotected sex among high school students in Miami, potentially preventing pregnancy and STIs like HIV. One group will experience the Relationship Smarts Plus program combined with trauma-coping lessons, while another group will use only the Relationship Smarts Plus curriculum. A third group will focus on financial literacy for comparison. The trial targets Miami-area high school students in mainstream classrooms without significant cognitive or mental health challenges.

As an unphased trial, this study offers students the chance to contribute to important research that could enhance educational programs and improve health outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It seems focused on educational programs rather than medical treatments, so it's unlikely that medication changes are required.

What prior data suggests that these programs are safe for adolescents?

Research has shown that both the Relationship Smarts Plus program and its enhanced version with Mind Matters are safe for teens. These programs teach skills for healthy relationships and making smart choices about sex. Past studies reported no serious side effects or negative events from participation. Instead, participants often experience positive outcomes, such as a better understanding of healthy relationships and improved decision-making skills.

Since this trial involves educational programs rather than testing a new drug or medical procedure, the risks are minimal. The focus is on learning and personal growth, which participants generally handle well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for adolescent pregnancy prevention because they combine relationship education with additional skills that address emotional well-being. Relationship Smarts Plus (RSP+) is designed to teach adolescents about healthy relationships, but one of the treatments takes it a step further by integrating lessons from the Mind Matters (MM) curriculum, which focuses on trauma-coping skills. This combination is unique because it not only aims to prevent pregnancy by fostering informed relationships but also supports mental health, which can be a significant factor in decision-making for adolescents. By addressing both relationship skills and emotional health, these programs have the potential to offer a more comprehensive approach than traditional pregnancy prevention methods.

What evidence suggests that this trial's treatments could be effective for preventing adolescent pregnancy and STIs?

Research has shown that the Relationship Smarts Plus program, one of the programs tested in this trial, effectively teaches teens about healthy relationships, dating violence, and pregnancy prevention. One study found that participants improved their decision-making skills and gained a better understanding of intimacy and sexual health. The program teaches young people positive relationship skills, which may lead to less unprotected sex.

In this trial, one group of participants will receive the Relationship Smarts Plus program combined with Mind Matters, which teaches trauma-coping skills. Early findings suggest that combining these programs might help teens become more emotionally resilient, possibly reducing risky behaviors like unprotected sex. While detailed data on this combination is still being gathered, the approach looks promising based on the success of each program individually. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for 9th and 10th graders in the greater Miami area who are at high risk of pregnancy and STIs. Participants should be able to attend mainstream classes without severe cognitive, mental health, or behavioral impairments.

Inclusion Criteria

For schools to be included in the study, they have to be located within the greater Miami area

I do not have severe cognitive, mental health, or behavioral issues.

I am a student with an Individualized Education Plan in a mainstream classroom.

Exclusion Criteria

Students who do not consent to be in the study

Students who are part of the pilot study

Students who have been randomized in a previous cohort of the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Relationship Smarts Plus curriculum with or without the Mind Matters curriculum

14-18.5 hours

Classroom sessions

Post-Program Assessment

Participants complete surveys to assess immediate outcomes after the program

1 week

1 visit (in-person or virtual)

Follow-up

Participants are monitored for behavioral health outcomes at 3 months and 12 months after baseline

12 months

2 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Preparing Adolescents for Young Adulthood (PAYA)
• Relationship Smarts Plus
• Relationship Smarts+ With Lessons From Mind Matters

Trial Overview

The study tests if adding Mind Matters trauma-coping skills curriculum to Relationship Smarts Plus reduces unprotected sex rates among teens compared to just Relationship Smarts Plus or financial literacy (PAYA).

How Is the Trial Designed?

Group I: Relationship Smarts Plus & Mind Matters Experimental Treatment 1 Intervention

Relationship Smarts Plus (RSP+) is an adolescent pregnancy prevention curriculum that will be combined with lessons from a trauma-coping skills curriculum, Mind Matters (MM).

Group II: Relationship Smarts Plus Experimental Treatment 1 Intervention

Relationship Smarts Plus (RSP+) is an adolescent pregnancy prevention curriculum.

Group III: Control Group Active Control 1 Intervention

Financial literacy curriculum, Preparing Adolescents for Young Adulthood (PAYA)

Relationship Smarts Plus is already approved in United States for the following indications:

Approved in United States as Relationship Smarts Plus for:

• Adolescent pregnancy prevention
• Sexually Transmitted Infections (STIs) prevention
• HIV/AIDS prevention

Who Is Running the Clinical Trial?

Trinity Church Inc.

Lead Sponsor

Trials

1

Recruited

2,300+

AMTC & Associates

Collaborator

Trials

2

Recruited

4,900+

Department of Health and Human Services

Collaborator

Trials

240

Recruited

944,000+

Published Research Related to This Trial

The research highlights the importance of romantic relationships in adolescent development, indicating that positive experiences can foster personal growth, while negative experiences may lead to unhealthy relationship patterns later in life.

The youth-focused relationships education curriculum was found to be effective, as evidenced by pre and post-intervention assessments and follow-up surveys, suggesting it can serve as a valuable model for teaching adolescents about healthy relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a statewide youth-focused relationships education curriculum. Kerpelman, JL., Pittman, JF., Adler-Baeder, F., et al.[2009]

Couple relationship education (RE) has been shown to help maintain relationship satisfaction over time, with 14 out of 17 studies indicating positive effects in couples assessed at least one year after the program.

Couples facing modifiable risk factors see significant benefits from RE, while those with low risk factors or unmodifiable risks may not experience the same advantages, highlighting the need for tailored approaches in relationship education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of relationship education on maintenance of couple relationship satisfaction. Halford, WK., Bodenmann, G.[2013]

Couples who participated in a structured communication version of the Prevention and Relationship Education Program (PREP) showed more positive communication behaviors and fewer negative ones at the 6-month follow-up compared to those who did not receive structured communication training.

Both groups of couples experienced a decrease in negative communication patterns, but there was no significant change in overall relationship adjustment, indicating that while communication improved, it did not necessarily translate to a better overall relationship status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dismantling study of prevention and relationship education program: the effects of a structured communication intervention. Owen, J., Manthos, M., Quirk, K.[2013]

The Prevention and Relationship Enhancement Program (PREP) significantly improved communication skills and relationship quality among 321 lower-income and racial/ethnic minority couples, demonstrating its effectiveness in enhancing relationship functioning.

Couples who participated in PREP in a couple format experienced better outcomes in relationship quality compared to those in a group format, suggesting that the delivery method can influence the effectiveness of relationship interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of PREP with lower-income racial/ethnic minority couples. Owen, J., Quirk, K., Bergen, C., et al.[2022]

All five reviewed adolescent pregnancy prevention programs effectively emphasized abstinence, decision-making skills, and education on sexuality and contraception, with four providing access to contraceptive services.

Programs targeting younger adolescents were particularly successful, reducing sexual initiation by up to 15 percentage points and increasing contraceptive use by as much as 22 percentage points, with the most effective programs also significantly decreasing pregnancy rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding the impact of effective teenage pregnancy prevention programs. Frost, JJ., Forrest, JD.[2022]

Community-based and school-based clinics are effective components of adolescent pregnancy prevention programs, providing essential resources and support.

Programs that combine contraceptive knowledge with comprehensive sex education and skills training are identified as best practices for effectively reducing adolescent pregnancy rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing adolescent pregnancy: a review of programs and practices. Franklin, C., Corcoran, J.[2019]

Traditional pregnancy prevention methods for adults and older teens do not adequately address the unique developmental needs of early adolescents, highlighting the need for tailored approaches.

Focusing on interpersonal relationships, especially between young teens and their parents, can significantly enhance decision-making and effectiveness in preventing teen pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A developmental approach to pregnancy prevention with early adolescent females. Proctor, SE.[2019]

The Date SMART intervention significantly reduced physical and sexual adolescent dating violence (ADV) among juvenile-justice involved females, with participants reporting fewer incidents compared to a control group, indicating its efficacy in this population.

Participants in the Date SMART program also reported fewer sexual risk behaviors, specifically a reduction in vaginal and anal sex acts, suggesting that the intervention not only addresses dating violence but also promotes safer sexual practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dating Violence Prevention for Juvenile-Justice Involved Females: A Hybrid Trial. Rizzo, CJ., Collibee, C., Barker, D., et al.[2023]

A client-centered approach to preventing adolescent pregnancy, involving tailored services like counseling and mentoring, showed some positive effects, such as reduced intentions for sexual activity and improved contraceptive use among high-risk youth.

The study, which included 1,732 participants across various age groups, highlighted that high-risk adolescents may require more intensive and longer interventions than typically offered to effectively reduce pregnancy risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using randomized designs to evaluate client-centered programs to prevent adolescent pregnancy. McBride, D., Gienapp, A.[2006]

Couples who participated in the RELATE + Couple CARE program showed greater improvements in communication and relationship satisfaction over 12 months compared to those who only received the RELATE assessment.

While women benefited more from the additional Couple CARE training, men maintained similar levels of relationship satisfaction in both programs, indicating that skill training can enhance outcomes for couples.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Couple relationship education at home: does skill training enhance relationship assessment and feedback? Halford, WK., Wilson, K., Watson, B., et al.[2015]

Adolescents face significant challenges in sexual and reproductive health, including sexually transmitted diseases and unintended pregnancies, highlighting the need for innovative prevention strategies.

Focusing on promoting healthy relationships is a promising approach that could improve adolescent sexual and reproductive health outcomes, necessitating the development of a science-based conceptual framework to guide these efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancing adolescent sexual and reproductive health by promoting healthy relationships. Tharp, AT., Carter, M., Fasula, AM., et al.[2013]

This scoping review identified 15 unique digital health interventions (DHIs) aimed at promoting healthy romantic relationships among adolescents, developed across 11 countries, highlighting the potential for culturally tailored programming.

While some DHIs showed small positive effects on communication skills related to healthy relationships, further research is needed to establish effective outcomes and evaluation measures, as well as to explore broader social contexts influencing adolescent relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Scoping Review of Digital Health Interventions to Promote Healthy Romantic Relationships in Adolescents. Emerson, A., Pickett, M., Moore, S., et al.[2023]

The Date SMART program effectively reduces physical dating violence perpetration among high-risk adolescent girls, particularly those with higher initial levels of depressive symptoms, as shown in a study with 109 participants.

Adolescents with varying levels of depressive symptoms respond differently to dating violence prevention programs, highlighting the importance of tailoring interventions to individual risk profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depressive Symptoms Moderate Dating Violence Prevention Outcomes Among Adolescent Girls. Collibee, C., Rizzo, CJ., Kemp, K., et al.[2023]

Citations

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dibbleinstitute.org

dibbleinstitute.org/our-programs/rsp-5-0/?srsltid=AfmBOor1DNY30e0iv4HDSTC71rzjDnYALYTTMwegb_Ad0lsXFL2wFAks

Relationship Smarts PLUS 5.0

Relationship Smarts PLUS 5.0 is a 13-lesson evidence-based relationship skills curriculum for young teens (ages 12-16). The curriculum integrates positive youth ...

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acf.gov

acf.gov/sites/default/files/documents/opre/Remediated--Relationship%20Smarts%20PLUS%20one-year%20impacts.pdf

The One-Year Impacts of Two Versions of Relationship Smart

Adolescent Pregnancy Prevention Approaches (Smith et al. 2012); index values range from 0 to 5, indicating the total number of correct responses. RQ+ ...

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dibbleinstitute.org

dibbleinstitute.org/our-programs/relationship-smarts-plus/?srsltid=AfmBOooei2TapbF9vwoPoxYekmFRyS0ztR7SSlj9Xa5Et5E7KiJ26BKO

Relationship Smarts PLUS

Relationship Smarts PLUS is a 13-lesson curriculum for teens that addresses healthy relationships, dating violence, and pregnancy prevention, empowering youth ...

4.

bgsu.edu

bgsu.edu/content/dam/BGSU/college-of-arts-and-sciences/NCFMR/documents/WP/WP-09-12.pdf

Relationship Smarts

The aim of this report is to evaluate how participation in the Relationship Smarts relationship education program leads to changes in teenagers' views of ...

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researchgate.net

researchgate.net/publication/260335310_An_Evaluation_of_the_Relationship_Smarts_Plus_Program_on_Adolescents_in_Georgia

(PDF) An Evaluation of the Relationship Smarts Plus ...

The present study examines the impact of Relationship Smarts Plus among 1,657 adolescents age 12-18 across 25 Georgia counties.

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dibbleinstitute.org

dibbleinstitute.org/our-programs/relationship-smarts-plus/?srsltid=AfmBOorQraXbYHyoCLWOvqfOn8W_lyf74DqHmfrrrvaihDRTTY1CYBcT

Relationship Smarts PLUS

Relationship Smarts PLUS is a 13-lesson curriculum for teens that addresses healthy relationships, dating violence, and pregnancy prevention, empowering youth ...

7.

dibbleinstitute.org

dibbleinstitute.org/our-programs/rsp-5-0/?srsltid=AfmBOoo1dF49VNgxQ1w_LLBHKxQthZc0gi74GSq3gCEVm0fACe6qzHat

Relationship Smarts PLUS 5.0

Relationship Smarts PLUS 5.0 is a 13-lesson program for teens (12-16) covering healthy relationships, dating, sex, and new topics like sex trafficking and ...

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fcs.uga.edu

fcs.uga.edu/docs/RS_State_Impact_Report_2014_Summary.pdf

Relationship Smarts Plus (RS+) 2008-2014 Impact ...

Outcomes: Participating youth report increased capacity to develop healthy relationships. Of the 3445 youth who participated in at least one RS+ class, data was ...