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

Official title

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

Overview

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).

Interventions

• 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. * Gend
• 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.
• 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 influen
• 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
• 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.
• 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.
• 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.
• 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.

Primary outcome measures

• Feasibility of factorial trial design [Time frame: Through study completion (anticipated 2.5 years)]
• Acceptability of intervention components [Time frame: Immediately after completing the intervention]

Eligibility criteria

Inclusion criteria for teens:

• Identify as Latina
• Be 14-18 years old
• Speak English and/or Spanish
• Be available and have a female caregiver who is available for the workshop and research activities.
• Be living with or in daily contact with the female caregiver.

Inclusion criteria for female caregivers:

• Be the mother or a female caregiver (e.g., aunt, sister, grandmother) of a Latina teen (aged 14-18 years old)
• Be 19 years old or older
• Speak English and/or Spanish
• Be available and have a teen who is available for the workshop and research activities.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Factorial

Masking

Single blind

Primary purpose

Prevention

Study locations

United States · 4 centers

• Gads Hill Center — Chicago
• Expanded Mental Health Services of Chicago NFP — Chicago
• Centro Romero — Chicago
• Corazon Community Services — Cicero

Identifiers

NCT: NCT06223165 · 2022-0207

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗