About 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 accepts healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Factorial
Treatments tested in this trial
Floreciendo (Foundations, Condoms & Contraception, Family Strengthening, and Gender & Relationships)
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.
Floreciendo (Foundations, Condoms & Contraception, and Family Strengthening)
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.
Floreciendo (Foundations, Condoms & Contraception, Gender & Relationships)
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.
Floreciendo (Foundations, Family Strengthening, and Gender & Relationships)
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.
Floreciendo (Foundations and Condoms & Contraception)
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.
Floreciendo (Foundations and Family Strengthening)
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.
Floreciendo (Foundations and Gender & Partner Relationships)
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.
Floreciendo (Foundations)
Behavioral• Foundations in sexual risk prevention: Covers key topics in sexual and reproductive health and helps participants develop an awareness of sexual behavior risks.
Treatment groups
8
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
Feasibility of factorial trial design
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
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
Other outcomes
Exploratory primary effectiveness outcome: Sexual risk behavior
Proportion of teens who report risky sexual behavior at baseline and follow-up (self-reported using AIDS Risk Behavior Assessment)
Exploratory secondary effectiveness outcome: sexually transmitted infections
Proportion of teens with a sexually transmitted infection (STI) at baseline and follow-up.
Exploratory secondary effectiveness outcome: Unplanned pregnancy
Proportion of teens with an unplanned pregnancy at baseline and follow-up (self-reported)
Exploratory implementation outcomes
We will explore feasibility of implementing the Floreciendo intervention, appropriateness, adoption, sustainability, cost, and fidelity.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Illinois at Chicago
Lead sponsor
Centro Romero
Collaborator
Expanded Mental Health Services of Chicago
Collaborator
Corazon Community Services
Collaborator
Gads Hill Center
Collaborator