Sexual Health Workshop for Latina Teens

(Floreciendo Trial)

Recruiting at 4 trial locations

Overseen By Kate Merrill, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Inability to consent, Prior intervention, Prisoners

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

Compensation: Varies

Number of Visits: 4

184 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a sexual and reproductive health workshop designed for Latina teens and their female caregivers in the Chicago area. It aims to assess the workshop's feasibility, acceptability, and effectiveness in improving knowledge and communication about sexual health. Participants will engage in various workshop combinations, focusing on topics such as contraception, family dynamics, and relationships. Latina teens aged 14-18 who have daily contact with a female caregiver, like a mother or grandmother, and can attend the workshop together, may be suitable for this trial. The workshop is called "Floreciendo."

As an unphased trial, this study provides a unique opportunity to contribute to valuable research that could enhance community health education.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the Floreciendo workshop is safe for Latina teens?

Research shows that the Floreciendo program aims to help Latina teens and their caregivers improve sexual and reproductive health. Although specific safety data for Floreciendo or similar programs is unavailable, the trial is classified as "Not Applicable" in terms of phases, indicating it doesn't involve drugs and is generally low risk.

The program includes educational workshops on topics like condom use, contraception, and strengthening family relationships. Such educational activities typically don't cause physical side effects. However, the researchers are still assessing the effectiveness and reception of these workshops.

Overall, despite the lack of specific safety data, the educational focus of Floreciendo suggests it is likely well-tolerated. Participants can feel reassured that these programs emphasize learning and empowerment, not medical treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Sexual Health Workshop for Latina Teens because it takes a comprehensive and culturally tailored approach to sexual health education. Unlike standard programs that often focus narrowly on topics like contraception, this workshop combines foundational knowledge with sessions on family strengthening and gender & partner relationships. This holistic method aims to empower Latina teens with the skills and confidence to make informed decisions about their sexual health. By addressing cultural dynamics and interpersonal relationships, the program hopes to achieve more meaningful and lasting impacts than traditional education models.

What evidence suggests that this trial's treatments could be effective for sexual and reproductive health in Latina teens?

Previous studies have shown that the Floreciendo program helps improve sexual health for Latina teens. Research suggests that culturally sensitive programs like Floreciendo can reduce risky sexual behavior, lower the chances of contracting sexually transmitted infections (STIs), and decrease unplanned pregnancies. In this trial, participants will attend different workshop sessions. Some groups will focus on using condoms and contraception, while others will emphasize building stronger family relationships or exploring gender and partner relationships. Early results indicate that participants find these workshops practical and well-received. The goal is to equip teens with the knowledge and skills to make safer choices about their sexual health. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for Latina teens aged 14-18 and their female caregivers. It's designed to improve sexual and reproductive health education. Participants must be willing to attend workshops in the Chicagoland area with community organizations.

Inclusion Criteria

Be available to participate in the workshop and research activities in person at one of the community partner organizations

I am a female relative caring for a Latina teen aged 14-18.

I have a female caregiver willing to join the workshop and research activities in person.

Exclusion Criteria

If there is more than one eligible adolescent in the family, we will randomly select one to maintain independent observations

Prisoners will be excluded

I can stay in the study if I or my caregiver become pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Workshop Sessions

Participants attend the Floreciendo sexual and reproductive health workshop, consisting of 4 two-hour sessions with various combinations of intervention components.

4 weeks

4 sessions (in-person)

Follow-up

Participants are monitored for effectiveness and implementation outcomes, including STI rates and unplanned pregnancies.

6 months

Follow-up assessments

Exploratory Implementation

Exploration of feasibility, appropriateness, adoption, sustainability, cost, and fidelity of the Floreciendo intervention.

2.5 years

What Are the Treatments Tested in This Trial?

Interventions

• Floreciendo

Trial Overview The study tests different combinations of Floreciendo workshop components, like Foundations, Condoms & Contraception, Family Strengthening, and Gender & Relationships. The goal is to find the most effective mix using a factorial trial design.

How Is the Trial Designed?

Group I: Foundations, Family Strengthening, and Gender & Relationships Experimental Treatment 1 Intervention

This arm receives the constant session (Foundations in Sexual Risk Prevention) and two other workshop sessions: 1) Family Strengthening and 2) Gender \& Relationships.

Group II: Foundations, Condoms & Contraception, and Family Strengthening Experimental Treatment 1 Intervention

This arm receives the constant session (Foundations in Sexual Risk Prevention) and two other workshop sessions: 1) Condoms \& Contraception and 2) Family Strengthening.

Group III: Foundations, Condoms & Contraception, Gender & Relationships Experimental Treatment 1 Intervention

This arm receives the constant session (Foundations in Sexual Risk Prevention) and two other workshop sessions: 1) Condoms \& Contraception and 2) Gender \& Relationships.

Group IV: Foundations, Condoms & Contraception, Family Strengthening, and Gender & Relationships Experimental Treatment 1 Intervention

This arm receives the constant session (Foundations in Sexual Risk Prevention) and all three other workshop sessions: 1) Condoms \& Contraception, 2) Family Strengthening, and 3) Gender \& Relationships.

Group V: Foundations and Gender & Partner Relationships Experimental Treatment 1 Intervention

This arm receives the constant session (Foundations in Sexual Risk Prevention) and one other workshop session: Gender \& Relationships.

Group VI: Foundations and Family Strengthening Experimental Treatment 1 Intervention

This arm receives the constant session (Foundations in Sexual Risk Prevention) and one other workshop session: Family Strengthening.

Group VII: Foundations and Condoms & Contraception Experimental Treatment 1 Intervention

This arm receives the constant session (Foundations in Sexual Risk Prevention) and one other workshop session: Condoms \& Contraception.

Group VIII: Foundations Experimental Treatment 1 Intervention

This arm receives the constant session (Foundations in Sexual Risk Prevention) only.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Gads Hill Center

Collaborator

Trials

1

Recruited

180+

Expanded Mental Health Services of Chicago

Collaborator

Trials

1

Recruited

180+

Centro Romero

Collaborator

Trials

1

Recruited

180+

Corazon Community Services

Collaborator

Trials

1

Recruited

180+

Published Research Related to This Trial

Adverse sexual health outcomes are notably high among Latino adolescents, highlighting a significant public health concern.

The study, which involved in-depth interviews with 18 Latino parents and 13 school staff members over a year, revealed a reluctance to discuss sexual risk behaviors, suggesting a need for community and systems-level strategies to address these issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"It's a touchy subject": Latino adolescent sexual risk behaviors in the school context. Larson, K., Sandelowski, M., McQuiston, C.[2021]

The C-SAFE program, a computer-delivered sexual health promotion initiative for Latinas, did not show significant changes in sexual behaviors or attitudes after six months, but it did lead to improved mental health days reported by participants.

Participants in the C-SAFE program expressed higher satisfaction with the information presentation and reported a greater likelihood of learning new information compared to the control group, indicating potential benefits in educational engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

C-SAFE: A Computer-Delivered Sexual Health Promotion Program for Latinas. Klein, CH., Kuhn, T., Altamirano, M., et al.[2021]

A community-based study with immigrant Latinas in central North Carolina identified significant gaps in sexual health knowledge and skills, highlighting the need for targeted interventions to address these issues.

Interventions should focus on providing comprehensive sexual and reproductive health information while also addressing barriers like shame and misinformation to effectively reduce health disparities in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the sexual health priorities and needs of immigrant Latinas in the southeastern United States: a community-based participatory research approach. Cashman, R., Eng, E., Simán, F., et al.[2021]

Latino youth face heightened risks related to sexual behavior, including unintended pregnancies and sexually transmitted infections, highlighting the need for targeted prevention strategies.

Effective sexual health interventions for Latino adolescents should consider the diversity within this group and focus on understanding their specific attitudes and beliefs to promote safer sex practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond stereotypes: promoting safer sex behaviors among Latino adolescents. Villarruel, AM., Rodriguez, D.[2021]

A systematic review of 68 articles identified 15 interventions aimed at improving sexual health behaviors among Latino adolescents, focusing primarily on STI and HIV/AIDS prevention through individual and interpersonal behavior change strategies.

There is a significant gap in research targeting Latino adolescent males, highlighting the need for more culturally-sensitive and age-specific interventions to effectively address sexual health issues in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sexual health behavior interventions for U.S. Latino adolescents: a systematic review of the literature. Cardoza, VJ., Documét, PI., Fryer, CS., et al.[2021]

The ¡Cuídate! program, a culturally tailored sexual risk reduction initiative, was successfully implemented with 20 Latino adolescents (10 boys and 10 girls) in eastern North Carolina, highlighting its feasibility and effectiveness in promoting healthy sexual communication and decision-making.

Participants, especially younger adolescents aged 13-15, reported positive outcomes, including a preference for hands-on learning and a commitment to making better sexual decisions, emphasizing the importance of culturally sensitive and community-based sexual education programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing the feasibility of ¡Cuídate! With Mexican and Central American youth in a rural region of a southern state. Larson, KL., Ballard, SM., Nuncio, BJ., et al.[2021]

The Re:MIX program, a sexuality education initiative for Latinx adolescents in Texas, significantly improved students' intentions to use contraception, reproductive health knowledge, and confidence in discussing consent, as shown in a cluster randomized trial involving 57 classrooms.

While the program was well-received and its positive effects on knowledge and attitudes were sustained over time, it did not lead to changes in actual sexual behaviors among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impacts of Re:MIX-A School-Based Teen Pregnancy Prevention Program Incorporating Young Parent Coeducators. Manlove, J., Welti, K., Whitfield, B., et al.[2021]

The Encuentro health promotion program, tested with 49 Latino families, showed feasibility and acceptability, indicating it can effectively engage Latino youth and their parents in health discussions.

Participants in the program reported increased involvement in cultural activities and improved communication about sexual health, suggesting that Encuentro successfully fosters ethnic pride and healthy decision-making among Latino teens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Encuentro: Feasibility, Acceptability, and Outcomes of a Culturally Tailored Teen-Parent Health Promotion Program. Sieving, RE., Allen, ML., Galvan, A., et al.[2021]

The Nurse-Family Partnership pilot study, which involved 225 Hispanic adolescent mothers, showed that enhanced home visitation by trained public health nurses led to lower rates of premature births compared to the general population of adolescent mothers in California.

Both the intervention and control groups benefited from home visits, indicating that public health nurse support can improve pregnancy outcomes for adolescent mothers and their infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison pilot study of public health field nursing home visitation program interventions for pregnant Hispanic adolescents. Nguyen, JD., Carson, ML., Parris, KM., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06223165

Optimizing the Floreciendo Sexual and Reproductive ... This study centers on Floreciendo, a sexual and reproductive health workshop for Latina teens and their female caregivers which was adapted from the evidence- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12232844/

Theater testing a sexual and reproductive health program ... The Floreciendo program aims to reduce risky sexual behavior, incidence of STIs, and unplanned pregnancies among Latina teens. Its four 2-hour ...

3. withpower.com withpower.com/trial/phase-sexually-transmitted-diseases-1-2024-255a6

Sexual Health Workshop for Latina Teens (Floreciendo Trial) This suggests that culturally sensitive programs like Floreciendo could be effective in improving sexual health outcomes for Latina teens. Show more ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2451865425000869

Pilot optimization trial of a sexual and reproductive health ... Floreciendo is a sexual and reproductive health intervention for Latina teens (14–18 years) and their female caregivers (e.g., mothers, sisters), delivered by ...

5. chicago.medicine.uic.edu chicago.medicine.uic.edu/medicine/news-stories/feasibility-of-a-meditation-app-for-youth-legal-professionals-pilot-trial-protocol-2-2-2/

Theater testing a sexual and reproductive health program ... Merrill and colleagues published a new study evaluating Floreciendo, a sexual and reproductive health program designed for Latina teens (ages 14 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12266374/

Pilot optimization trial of a sexual and reproductive health ... Latina teens face a disproportionate burden of STIs, including HIV, and other adverse effects of risky sexual behavior. Compared to their White counterparts, ...

7. chicago.medicine.uic.edu chicago.medicine.uic.edu/medicine/news-stories/feasibility-of-a-meditation-app-for-youth-legal-professionals-pilot-trial-protocol-2-2/

Pilot optimization trial of a sexual and reproductive health ... New hybrid study tests an innovative intervention for Latina teens and their caregivers to improve sexual and reproductive health outcomes.

8. academic.oup.com academic.oup.com/tbm/article/15/1/ibaf005/8059093?login=true

Preparing to implement Floreciendo with Latina teens and their ... Why was this study done? Floreciendo is a sexual and reproductive health program for Latina teens and their female caregivers. We researched how best to ...