Optimizing the Floreciendo Sexual and Reproductive Health Workshop for Latina Teens and Female Caregivers: A Pilot
- Conditions
- Sexually Transmitted InfectionsSexual Risk BehaviorUnplanned Pregnancy
- Interventions
- Behavioral: Floreciendo (Foundations and Family Strengthening)Behavioral: Floreciendo (Foundations and Gender & Partner Relationships)Behavioral: Floreciendo (Foundations, Condoms & Contraception, and Family Strengthening)Behavioral: Floreciendo (Foundations, Condoms & Contraception, Gender & Relationships)Behavioral: Floreciendo (Foundations and Condoms & Contraception)Behavioral: Floreciendo (Foundations, Condoms & Contraception, Family Strengthening, and Gender & Relationships)Behavioral: Floreciendo (Foundations, Family Strengthening, and Gender & Relationships)Behavioral: Floreciendo (Foundations)
- Registration Number
- NCT06223165
- Lead Sponsor
- University of Illinois at Chicago
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 184
Not provided
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Foundations and Family Strengthening Floreciendo (Foundations and Family Strengthening) This arm receives the constant session (Foundations in Sexual Risk Prevention) and one other workshop session: Family Strengthening. Foundations and Gender & Partner Relationships Floreciendo (Foundations and Gender & Partner Relationships) This arm receives the constant session (Foundations in Sexual Risk Prevention) and one other workshop session: Gender \& Relationships. Foundations, Condoms & Contraception, and Family Strengthening Floreciendo (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. Foundations, Condoms & Contraception, Gender & Relationships Floreciendo (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. Foundations and Condoms & Contraception Floreciendo (Foundations and Condoms & Contraception) This arm receives the constant session (Foundations in Sexual Risk Prevention) and one other workshop session: Condoms \& Contraception. Foundations, Condoms & Contraception, Family Strengthening, and Gender & Relationships Floreciendo (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. Foundations, Family Strengthening, and Gender & Relationships Floreciendo (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. Foundations Floreciendo (Foundations) This arm receives the constant session (Foundations in Sexual Risk Prevention) only.
- Primary Outcome Measures
Name Time Method Feasibility of factorial trial design Through study completion (anticipated 2.5 years) Proportion of conditions implemented according to the randomization schedule (benchmark is at least 90%) (primary). We will also measure the 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 80%).
Acceptability of intervention components Immediately after completing the intervention 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Corazon Community Services
🇺🇸Cicero, Illinois, United States
Expanded Mental Health Services of Chicago NFP
🇺🇸Chicago, Illinois, United States
Gads Hill Center
🇺🇸Chicago, Illinois, United States
Centro Romero
🇺🇸Chicago, Illinois, United States