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

NCT ID: NCT06223165

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-09
• Study Completion Date: 2026-08-31

Brief 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 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.

Detailed 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 Latine 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, and 2) acceptability of the intervention components. We will also explore effectiveness outcomes and implementation outcomes. Data will be collected at baseline and follow-up (roughly 6 months post).

Conditions

Sexual Risk Behavior; Sexually Transmitted Infections; Unplanned Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Foundations, Condoms & Contraception, Family Strengthening, and Gender & Relationships

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 Type: EXPERIMENTAL

Floreciendo (Foundations, Condoms & Contraception, Family Strengthening, and Gender & Relationships)

Intervention Type: BEHAVIORAL

• 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.

Foundations, Condoms & Contraception, and Family Strengthening

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

Group Type: EXPERIMENTAL

Floreciendo (Foundations, Condoms & Contraception, and Family Strengthening)

Intervention Type: BEHAVIORAL

• 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.

Foundations, Condoms & Contraception, Gender & Relationships

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

Group Type: EXPERIMENTAL

Floreciendo (Foundations, Condoms & Contraception, Gender & Relationships)

Intervention Type: BEHAVIORAL

• 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.

Foundations, Family Strengthening, and Gender & Relationships

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

Group Type: EXPERIMENTAL

Floreciendo (Foundations, Family Strengthening, and Gender & Relationships)

Intervention Type: BEHAVIORAL

• 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.

Foundations and Condoms & Contraception

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

Group Type: EXPERIMENTAL

Floreciendo (Foundations and Condoms & Contraception)

Intervention Type: BEHAVIORAL

• 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.

Foundations and Family Strengthening

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

Group Type: EXPERIMENTAL

Floreciendo (Foundations and Family Strengthening)

Intervention Type: BEHAVIORAL

• 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.

Foundations and Gender & Partner Relationships

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

Group Type: EXPERIMENTAL

Floreciendo (Foundations and Gender & Partner Relationships)

Intervention Type: BEHAVIORAL

• 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.

Foundations

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

Group Type: EXPERIMENTAL

Floreciendo (Foundations)

Intervention Type: BEHAVIORAL

• Foundations in sexual risk prevention: Covers key topics in sexual and reproductive health and helps participants develop an awareness of sexual behavior risks.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Identify as Latina

2. Be 14-18 years old

3. Speak English and/or Spanish

4. Be available and have a female caregiver who is available for the workshop and research activities.

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

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 and have a teen who is available for the workshop and research activities.

5. 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 or if they already received the intervention in a previous phase of the research. 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.

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centro Romero

UNKNOWN

Sponsor Role: collaborator

Expanded Mental Health Services of Chicago

UNKNOWN

Sponsor Role: collaborator

Corazon Community Services

UNKNOWN

Sponsor Role: collaborator

Gads Hill Center

UNKNOWN

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gads Hill Center

Chicago, Illinois, United States

Site Status: RECRUITING

Expanded Mental Health Services of Chicago NFP

Chicago, Illinois, United States

Site Status: RECRUITING

Centro Romero

Chicago, Illinois, United States

Site Status: RECRUITING

Corazon Community Services

Cicero, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kate Merrill, PhD

Role: CONTACT

kgm@uic.edu

312-413-0386

Facility Contacts

Kate Merrill, PhD

Role: primary

kgm@uic.edu

312-413-0386

Kate Merrill, PhD

Role: primary

kgm@uic.edu

312-413-0386

Kate Merrill, PhD

Role: primary

kgm@uic.edu

312-413-0386

Kate Merrill, PhD

Role: primary

kgm@uic.edu

312-413-0386

Other Identifiers

2022-0207

Identifier Type: -

Identifier Source: org_study_id