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

May 8, 2024 updated by: University of Illinois at Chicago

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Estimated)

184

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kate Merrill, PhD
  • Phone Number: 312-413-0386
  • Email: kgm@uic.edu

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60608
        • Recruiting
        • Gads Hill Center
        • Contact:
          • Kate Merrill, PhD
          • Phone Number: 312-413-0386
          • Email: kgm@uic.edu
      • Chicago, Illinois, United States, 60647
        • Recruiting
        • Expanded Mental Health Services of Chicago NFP
        • Contact:
          • Kate Merrill, PhD
          • Phone Number: 312-413-0386
          • Email: kgm@uic.edu
      • Chicago, Illinois, United States, 60660
        • Recruiting
        • Centro Romero
        • Contact:
          • Kate Merrill, PhD
          • Phone Number: 312-413-0386
          • Email: kgm@uic.edu
      • Cicero, Illinois, United States, 60804
        • Recruiting
        • Corazon Community Services
        • Contact:
          • Kate Merrill, PhD
          • Phone Number: 312-413-0386
          • Email: kgm@uic.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Experimental: 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.
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.
Experimental: 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.
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.
Experimental: 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.
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.
Experimental: Foundations and Condoms & Contraception
This arm receives the constant session (Foundations in Sexual Risk Prevention) and one other workshop session: Condoms & Contraception.
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.
Experimental: Foundations and Family Strengthening
This arm receives the constant session (Foundations in Sexual Risk Prevention) and one other workshop session: Family Strengthening.
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.
Experimental: Foundations and Gender & Partner Relationships
This arm receives the constant session (Foundations in Sexual Risk Prevention) and one other workshop session: Gender & Relationships.
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.
Experimental: Foundations
This arm receives the constant session (Foundations in Sexual Risk Prevention) only.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of factorial trial design
Time Frame: Through study completion (anticipated 2.5 years)
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)
Acceptability of intervention components
Time Frame: 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
Immediately after completing the intervention
Preliminary effectiveness: Sexual risk behavior
Time Frame: Baseline to 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preliminary effectiveness: sexually transmitted infections
Time Frame: Baseline to 6 months
Proportion of teens with a sexually transmitted infection (STI) at baseline and follow-up
Baseline to 6 months
Preliminary effectiveness: unplanned pregnancy
Time Frame: Baseline to 6 months
Proportion of teens with an unplanned pregnancy at baseline and follow-up (self-reported)
Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Collaborators

Centro Romero
Expanded Mental Health Services of Chicago
Corazon Community Services
Gads Hill Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

January 4, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 25, 2024

Study Record Updates

Last Update Posted (Actual)

May 10, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-0207

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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