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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14+
SponsorUniversity of Illinois at Chicago

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 volunteers

Qualifiers

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

Design model

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

184 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Foundations, Condoms & Contraception, Family Strengthening, and Gender & RelationshipsExperimental treatment 1 intervention
Group B: Foundations, Condoms & Contraception, and Family StrengtheningExperimental treatment 1 intervention
Group C: Foundations, Condoms & Contraception, Gender & RelationshipsExperimental treatment 1 intervention
Group D: Foundations, Family Strengthening, and Gender & RelationshipsExperimental treatment 1 intervention
Group E: Foundations and Condoms & ContraceptionExperimental treatment 1 intervention
Group F: Foundations and Family StrengtheningExperimental treatment 1 intervention
Group G: Foundations and Gender & Partner RelationshipsExperimental treatment 1 intervention
Group H: FoundationsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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%).

Time frame
Through study completion (anticipated 2.5 years)
2

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

Time frame
Immediately after completing the intervention

Secondary outcomes

Other outcomes

1

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)

Time frame
Baseline to follow-up
2

Exploratory secondary effectiveness outcome: sexually transmitted infections

Proportion of teens with a sexually transmitted infection (STI) at baseline and follow-up.

Time frame
Baseline to follow-up
3

Exploratory secondary effectiveness outcome: Unplanned pregnancy

Proportion of teens with an unplanned pregnancy at baseline and follow-up (self-reported)

Time frame
Baseline to follow-up
4

Exploratory implementation outcomes

We will explore feasibility of implementing the Floreciendo intervention, appropriateness, adoption, sustainability, cost, and fidelity.

Time frame
Through study completion (anticipated 2.5 years)

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