Optimizing the Floreciendo Sexual and Reproductive Health Workshop for Latina Teens and Female Caregivers: A Pilot

Sexually Transmitted Infections Clinical Trial

— Floreciendo  

Official title:

Evidence-based Sexual and Reproductive Health Intervention Using a Multiphase Optimization Strategy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06223165
• Other study ID #: 2022-0207
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2024
• Est. completion date: August 2026

Study information

• Verified date: May 2024
• Source: University of Illinois at Chicago
• Contact: Kate Merrill, PhD
• Phone: 312-413-0386
• Email: kgm[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 and preliminary effectiveness of the intervention components of Floreciendo will be examined. This work will be conducted in partnership with community-based organizations in the Chicagoland area.

Description:

In the U.S., Latina teens face a disproportionate burden of HIV/AIDS/sexually-transmitted infections (STIs) and other adverse consequences of risky sexual behavior. Parents play a key role in shaping the sexual behavior of their teens as they transition into adulthood. Positive parenting practices-including monitoring, open parent-child communication, and parent-child bonding-have been shown to deter teens' engagement in high-risk behavior. Interventions which engage parents have shown positive effects on youths' sexual health, including among Latinos. Effective Latina mother-daughter sexual health programs are critically needed since Latina mothers are less likely to discuss sexual risk behaviors with their teens than White or Black mothers but are greatly respected as figures of authority in Latino tradition.

This study centers on Floreciendo, a sexual and reproductive health workshop for Latina teens and their female caregivers which was adapted from the evidence-based IMARA (Informed, Motivated, Aware, and Responsible Adolescents and Adults) intervention. Floreciendo is comprised of 4 two-hour sessions, during which teens and caregivers complete separate and joint activities. This study will draw on the multiphase optimization strategy (MOST) framework, an engineering-inspired methodological framework for optimizing an intervention by identifying an intervention package that produces the best expected outcome achievable within key constraints.

The goal of the study is to carry out a pilot optimization trial of Floreciendo using the MOST framework. In partnership with community-based organizations in the Chicagoland area, approximately 92 teen-caregiver dyads (184 participants) will be enrolled. All participants will receive the first workshop session (the constant). In a 2 x 2 x 2 factorial design, small groups of teen-caregiver dyads will be randomized to receive different combinations of the remaining three workshop sessions (the intervention components): 1) condoms & contraception; 2) family strengthening, and 3) gender and relationships. Primary outcomes are: 1) feasibility of using a factorial trial design, 2) acceptability of the intervention components, and 3) preliminary effectiveness of the intervention components on sexual risk behavior. Secondary outcomes are preliminary effectiveness of the intervention components on incidence of STIs (a biological measure of chlamydia, gonorrhea, and trichomonas) and unplanned pregnancy (self-reported) at 6 months. Primary and secondary effectiveness outcomes will be assessed among teens.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion criteria for teens:

1. Identify as Latina

2. Be 14-18 years old

3. Speak English and/or Spanish

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

5. Have a female caregiver who is available to participate in the workshop and research activities in person at one of the community partner organizations

6. Be living with or in daily contact with the female caregiver.

Inclusion criteria for female caregivers:

1. Be the mother or a female caregiver (e.g., aunt, sister, grandmother) of a Latina teen (aged 14-18 years old)

2. Be 19 years old or older

3. Speak English and/or Spanish

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

5. Be invited by a Latina teen (14-18 years old) who is available to participate in the workshop and research activities in person at one of the community partner organizations

6. Be living with or in daily contact with the Latina teen.

Latina teens and female caregivers must agree to participate as a dyad, and teens' refusal will supersede parental consent.

Exclusion Criteria:

Teens and caregivers will be excluded if they are unable to understand the consent/assent process and provide informed consent/assent. Teens may or may not be sexually active; this will not be an exclusion criterium. Information about teens' sexual activity will not be shared with caregivers to reduce consent/assent barriers. If there is more than one eligible adolescent in the family, we will randomly select one to maintain independent observations. Teens or caregivers who become pregnant during the study may continue to participate. Prisoners will be excluded.

Related Conditions & MeSH terms

• Sexual Risk Behavior
• Sexually Transmitted Diseases
• Sexually Transmitted Infections
• Unplanned Pregnancy

Intervention

Behavioral:
• Floreciendo (Foundations, Condoms & Contraception, Family Strengthening, and Gender & Relationships)
Foundations in sexual risk prevention: Covers key topics in sexual and reproductive health and helps participants develop an awareness of sexual behavior risks. Condoms and contraception: Teaches about different forms of condoms and contraception and offers experiential activities on how to use them. Family strengthening: Facilitates learning and practice in how teens and their female caregivers can communicate about sex and addresses family norms and expectations in Latino culture. Gender and relationships: Covers what a healthy relationship looks like and how to recognize intimate partner violence, while discussing how gender and cultural norms in Latino culture influence teens' sexual behavior.
• Floreciendo (Foundations, Condoms & Contraception, and Family Strengthening)
Foundations in sexual risk prevention: Covers key topics in sexual and reproductive health and helps participants develop an awareness of sexual behavior risks. Condoms and contraception: Teaches about different forms of condoms and contraception and offers experiential activities on how to use them. Family strengthening: Facilitates learning and practice in how teens and their female caregivers can communicate about sex and addresses family norms and expectations in Latino culture.
• Floreciendo (Foundations, Condoms & Contraception, Gender & Relationships)
Foundations in sexual risk prevention: Covers key topics in sexual and reproductive health and helps participants develop an awareness of sexual behavior risks. Condoms and contraception: Teaches about different forms of condoms and contraception and offers experiential activities on how to use them. Gender and relationships: Covers what a healthy relationship looks like and how to recognize intimate partner violence, while discussing how gender and cultural norms in Latino culture influence teens' sexual behavior.
• Floreciendo (Foundations, Family Strengthening, and Gender & Relationships)
Foundations in sexual risk prevention: Covers key topics in sexual and reproductive health and helps participants develop an awareness of sexual behavior risks. Family strengthening: Facilitates learning and practice in how teens and their female caregivers can communicate about sex and addresses family norms and expectations in Latino culture. Gender and relationships: Covers what a healthy relationship looks like and how to recognize intimate partner violence, while discussing how gender and cultural norms in Latino culture influence teens' sexual behavior.
• Floreciendo (Foundations and Condoms & Contraception)
Foundations in sexual risk prevention: Covers key topics in sexual and reproductive health and helps participants develop an awareness of sexual behavior risks. Condoms and contraception: Teaches about different forms of condoms and contraception and offers experiential activities on how to use them.
• Floreciendo (Foundations and Family Strengthening)
Foundations in sexual risk prevention: Covers key topics in sexual and reproductive health and helps participants develop an awareness of sexual behavior risks. Family strengthening: Facilitates learning and practice in how teens and their female caregivers can communicate about sex and addresses family norms and expectations in Latino culture.
• Floreciendo (Foundations and Gender & Partner Relationships)
Foundations in sexual risk prevention: Covers key topics in sexual and reproductive health and helps participants develop an awareness of sexual behavior risks. Gender and relationships: Covers what a healthy relationship looks like and how to recognize intimate partner violence, while discussing how gender and cultural norms in Latino culture influence teens' sexual behavior.
• Floreciendo (Foundations)
• Foundations in sexual risk prevention: Covers key topics in sexual and reproductive health and helps participants develop an awareness of sexual behavior risks.

Locations

Country	Name	City	State
United States	Centro Romero	Chicago	Illinois
United States	Expanded Mental Health Services of Chicago NFP	Chicago	Illinois
United States	Gads Hill Center	Chicago	Illinois
United States	Corazon Community Services	Cicero	Illinois

Sponsors (5)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Centro Romero, Corazon Community Services, Expanded Mental Health Services of Chicago, Gads Hill Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of factorial trial design	A combined measure of: Proportion of conditions implemented according to the randomization schedule (benchmark is at least 90%), proportion of teen-caregiver dyads who complete all sessions specified per their condition (benchmark is at least 80%), and proportion of teen-caregiver dyads who complete baseline assessments (benchmark is at least 80%) and follow-up assessments (benchmark is at least 70%).	Through study completion (anticipated 2.5 years)
Primary	Acceptability of intervention components	Degree of satisfaction with the components of the Floreciendo workshop based on a measure of acceptability adapted from the mental health implementation science tool (mHIST), supplemented with qualitative feedback	Immediately after completing the intervention
Primary	Preliminary effectiveness: Sexual risk behavior	Proportion of teens who report risky sexual behavior at baseline and follow-up (self-reported using AIDS Risk Behavior Assessment)	Baseline to 6 months
Secondary	Preliminary effectiveness: sexually transmitted infections	Proportion of teens with a sexually transmitted infection (STI) at baseline and follow-up	Baseline to 6 months
Secondary	Preliminary effectiveness: unplanned pregnancy	Proportion of teens with an unplanned pregnancy at baseline and follow-up (self-reported)	Baseline to 6 months