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

NCT06223165 | Recruiting DMC

• 1 other identifier: 2022-0207
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 4

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.

Conditions

Sexual Risk Behavior; Sexually Transmitted Infections; Unplanned Pregnancy

Keywords

Sexual and reproductive health; Latina teens; Mother-daughter intervention

Outcome Measures

Primary Outcomes (2)

• 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%).

  Through study completion (anticipated 2.5 years)

• 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

  Immediately after completing the intervention

Other Outcomes (4)

• Exploratory primary effectiveness outcome: Sexual risk behavior

  Baseline to follow-up

• Exploratory secondary effectiveness outcome: sexually transmitted infections

  Baseline to follow-up

• Exploratory secondary effectiveness outcome: Unplanned pregnancy

  Baseline to follow-up

Study Arms (8)

Foundations, Condoms & Contraception, Family Strengthening, and Gender & Relationships

EXPERIMENTAL

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, Condoms & Contraception, and Family Strengthening

EXPERIMENTAL

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, Condoms & Contraception, Gender & Relationships

EXPERIMENTAL

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, Family Strengthening, and Gender & Relationships

EXPERIMENTAL

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 and Condoms & Contraception

EXPERIMENTAL

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 and Family Strengthening

EXPERIMENTAL

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 and Gender & Partner Relationships

EXPERIMENTAL

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

EXPERIMENTAL

This arm receives the constant session (Foundations in Sexual Risk Prevention) only.

Behavioral: Floreciendo (Foundations)

Interventions

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.

Foundations, Condoms & Contraception, Family Strengthening, and Gender & Relationships

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.

Foundations, Condoms & Contraception, and Family Strengthening

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.

Foundations, Condoms & Contraception, Gender & Relationships

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.

Foundations, Family Strengthening, and Gender & Relationships

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.

Foundations and Condoms & Contraception

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.

Foundations and Family Strengthening

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.

Foundations and Gender & Partner Relationships

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.

Foundations

Eligibility Criteria

• Age: 14 Years+
• Gender Eligibility Details: Teens and caregivers must identify as female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Centro Romero: collaborator
• Expanded Mental Health Services of Chicago: collaborator
• Corazon Community Services: collaborator
• Gads Hill Center: collaborator

Study Sites (4)

Gads Hill Center

Chicago, Illinois, 60608, United States

RECRUITING

Expanded Mental Health Services of Chicago NFP

Chicago, Illinois, 60647, United States

RECRUITING

Centro Romero

Chicago, Illinois, 60660, United States

RECRUITING

Corazon Community Services

Cicero, Illinois, 60804, United States

RECRUITING

MeSH Terms

Conditions

Sexually Transmitted Diseases; Coitus

Interventions

Foundations; Condoms; Contraception; Sex; Association

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Financial Support; Economics; Health Care Economics and Organizations; Organizations, Nonprofit; Organizations; Contraceptive Devices, Male; Contraceptive Devices; Equipment and Supplies; Reproductive Techniques; Therapeutics; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Psychotherapeutic Processes; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Kate Merrill, PhD

CONTACT

312-413-0386; kgm@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Recruiters and data collectors will be blind to the intervention condition. Teen-caregiver dyads will not know what intervention condition they are randomized into until they arrive on site for the first workshop session. Key study staff and intervention facilitators will be made aware of the intervention conditions for the purposes of delivering the workshop.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will run a 2 x 2 x 2 pilot factorial experiment. Small groups of Latina teen-female caregiver dyads will be randomized to one of eight conditions. All groups of dyads will receive the constant (i.e., the intervention session focused on foundations in sexual risk prevention). The remaining three intervention components are either delivered (i.e., "on") or not delivered (i.e., "off").

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 25, 2024
• Study Start: March 9, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)