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

2250 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Preparing Adolescents for Young Adulthood (PAYA) and Relationship Smarts programs for adolescent pregnancy prevention?

Research on relationship education programs shows that structured communication interventions can improve communication skills and relationship satisfaction, which are important for healthy relationships. Digital health interventions for adolescents have shown small positive effects on communication skills in romantic relationships, suggesting potential benefits for programs like PAYA and Relationship Smarts. ^{1 2 3 4 5}

Is the Adolescent Pregnancy Prevention Program safe for humans?

The research articles reviewed do not provide specific safety data for the Adolescent Pregnancy Prevention Programs or its related interventions. They focus on the effectiveness of relationship education and dating violence prevention, but do not mention any safety concerns. ^{2 6 7 8 9}

How is the treatment Relationship Smarts Plus unique in preventing adolescent pregnancy?

Relationship Smarts Plus is unique because it combines relationship education with lessons from Mind Matters, focusing on developing healthy romantic relationship skills and decision-making, rather than just emphasizing abstinence or contraceptive access. This approach aims to improve communication and interpersonal skills, which are crucial for adolescents' overall relationship health and decision-making. ^{2 10 11 12 13}

What is the purpose of this trial?

The goal of this randomized control trial (RCT) is to assess an innovative adolescent pregnancy prevention program among youth that are at the highest risk of adolescent pregnancy, to prevent pregnancy and Sexually Transmitted Infections (STIs), including HIV/AIDS in the greater Miami area in Florida. The primary research question it aims to answer is: (RQ1a): What is the effect of adding 4.5 hours of Mind Matters trauma-coping skills curriculum to the Relationship Smarts Plus curriculum, on rates of unprotected sex among 9th and 10th graders compared to the students receiving only the 14-hour-long Relationship Smarts Plus curriculum? (RQ1b): What is the effect of the 14-hour-long Relationship Smarts Plus curriculum on rates of unprotected sex among 9th and 10th graders compared to the control group receiving only financial literacy? Participants will complete program lessons and complete surveys for data collection. The RCT will assess behavioral health outcomes and other psychological outcomes at four-time points (baseline, post-program, 3 months, and 12 months)

Eligibility Criteria

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

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)

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Couple relationship education at home: does skill training enhance relationship assessment and feedback? [2015]

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

A Scoping Review of Digital Health Interventions to Promote Healthy Romantic Relationships in Adolescents. [2023]

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

Effects of relationship education on maintenance of couple relationship satisfaction. [2013]

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

Dismantling study of prevention and relationship education program: the effects of a structured communication intervention. [2013]

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

The effectiveness of PREP with lower-income racial/ethnic minority couples. [2022]

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

Advancing adolescent sexual and reproductive health by promoting healthy relationships. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Evaluation of a statewide youth-focused relationships education curriculum. [2009]

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

Dating Violence Prevention for Juvenile-Justice Involved Females: A Hybrid Trial. [2023]

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

Depressive Symptoms Moderate Dating Violence Prevention Outcomes Among Adolescent Girls. [2023]

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

Understanding the impact of effective teenage pregnancy prevention programs. [2022]

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

Using randomized designs to evaluate client-centered programs to prevent adolescent pregnancy. [2006]

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

Preventing adolescent pregnancy: a review of programs and practices. [2019]

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

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