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

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.

What data supports the effectiveness of the treatment Floreciendo in the Sexual Health Workshop for Latina Teens?

The ¡Cuídate! program, which is culturally tailored for Latino youth, showed that participants gained valuable sexual health knowledge and skills, leading to better decision-making about sex. This suggests that culturally sensitive programs like Floreciendo could be effective in improving sexual health outcomes for Latina teens. ^{1 2 3 4 5}

Is the Sexual Health Workshop for Latina Teens safe for participants?

The research articles do not provide specific safety data for the Sexual Health Workshop for Latina Teens or similar programs like Floreciendo. However, they emphasize the importance of creating a safe environment for discussing sexual health, which suggests a focus on participant safety and comfort. ^{1 2 5 6 7}

How is the treatment Floreciendo unique for Latina teens' sexual health?

Floreciendo is unique because it is a culturally tailored program specifically designed to address the sexual health needs of Latina teens, focusing on creating a safe environment for open communication and skill-building, which is not commonly found in standard treatments. ^{1 2 7 8 9}

What is the purpose of this trial?

Floreciendo is a sexual and reproductive health workshop for Latina teens (ages 14-18 years) and their female caregivers (e.g., mothers, sisters, grandmothers). This study involves conducting a pilot optimization trial of Floreciendo using the multiphase optimization strategy (MOST) framework. The feasibility of using a 2 x 2 x 2 factorial trial design and the acceptability of the intervention components of Floreciendo will be examined. Effectiveness and implementation outcomes will be explored. This work will be conducted in partnership with community-based organizations in the Chicagoland area.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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 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]

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]

References

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

Testing the feasibility of ¡Cuídate! With Mexican and Central American youth in a rural region of a southern state. [2021]

2. United States 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. [2021]

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

Impacts of Re:MIX-A School-Based Teen Pregnancy Prevention Program Incorporating Young Parent Coeducators. [2021]

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

A comparison pilot study of public health field nursing home visitation program interventions for pregnant Hispanic adolescents. [2021]

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

C-SAFE: A Computer-Delivered Sexual Health Promotion Program for Latinas. [2021]

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

Beyond stereotypes: promoting safer sex behaviors among Latino adolescents. [2021]

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

"It's a touchy subject": Latino adolescent sexual risk behaviors in the school context. [2021]

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

Encuentro: Feasibility, Acceptability, and Outcomes of a Culturally Tailored Teen-Parent Health Promotion Program. [2021]

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

Sexual health behavior interventions for U.S. Latino adolescents: a systematic review of the literature. [2021]