Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06223165 |
| Other study ID # |
2022-0207 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 9, 2024 |
| Est. completion date |
August 2026 |
Study information
| Verified date |
May 2024 |
| Source |
University of Illinois at Chicago |
| Contact |
Kate Merrill, PhD |
| Phone |
312-413-0386 |
| Email |
kgm[@]uic.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 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.
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.
