Clinical trial NCT06223165: Optimizing the Floreciendo Sexual and Reproductive Health Workshop for Latina Teens and Female Caregivers: A Pilot
Official title: Evidence-based Sexual and Reproductive Health Intervention Using a Multiphase Optimization Strategy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sexual Risk Behavior
Sexually Transmitted Infections
Unplanned Pregnancy
Keywords: Sexual and reproductive health
Latina teens
Mother-daughter intervention
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Centro Romero
name: Expanded Mental Health Services of Chicago
name: Corazon Community Services
name: Gads Hill Center
First posted: 2024-01-25
Enrollment: 184
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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").
Primary purpose: PREVENTION

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).

Eligibility criteria: Inclusion criteria for teens:

1. Identify as Latina
2. Be 14-18 years old
3. Speak English and/or Spanish
4. Be available and have a female caregiver who is available for the workshop and research activities.
5. 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 and have a teen who is available for the workshop and research activities.
5. 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 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.

Primary outcomes:
measure: Feasibility of factorial trial design
timeFrame: Through study completion (anticipated 2.5 years)
measure: Acceptability of intervention components
timeFrame: Immediately after completing the intervention
Secondary outcomes:
Other outcomes:
measure: Exploratory primary effectiveness outcome: Sexual risk behavior
timeFrame: Baseline to follow-up
measure: Exploratory secondary effectiveness outcome: sexually transmitted infections
timeFrame: Baseline to follow-up
measure: Exploratory secondary effectiveness outcome: Unplanned pregnancy
timeFrame: Baseline to follow-up
measure: Exploratory implementation outcomes
timeFrame: Through study completion (anticipated 2.5 years)
Locations:
city: Chicago
country: United States
facility: Gads Hill Center
state: Illinois
city: Chicago
country: United States
facility: Expanded Mental Health Services of Chicago NFP
state: Illinois
city: Chicago
country: United States
facility: Centro Romero
state: Illinois
city: Cicero
country: United States
facility: Corazon Community Services
state: Illinois
Study officials:
References: