Sexually Transmitted Infections, Sexual Risk Behavior, Unplanned Pregnancy
Conditions
Keywords
Sexual and reproductive health, Latina teens, Mother-daughter intervention
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).
Interventions
BEHAVIORALFloreciendo (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.
BEHAVIORALFloreciendo (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.
BEHAVIORALFloreciendo (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.
BEHAVIORALFloreciendo (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.
BEHAVIORALFloreciendo (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.
BEHAVIORALFloreciendo (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.
BEHAVIORALFloreciendo (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.
BEHAVIORALFloreciendo (Foundations)
• Foundations in sexual risk prevention: Covers key topics in sexual and reproductive health and helps participants develop an awareness of sexual behavior risks.
Sponsors
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
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").
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of factorial trial design | Through study completion (anticipated 2.5 years) | 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%). |
| Acceptability of intervention components | 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 |
Countries
United States
Outcome results
None listed