Sexual Risk BehaviorFloreciendoNCT06223165
Optimizing the Floreciendo Sexual and Reproductive Health Workshop for Latina Teens and Female Caregivers: A Pilot
A study testing Floreciendo (Foundations, Condoms & Contraception, Family Strengthening, and Gender & Relationships), Floreciendo (Foundations, Condoms & Contraception, and Family Strengthening) and Floreciendo (Foundations, Condoms & Contraception, Gender & Relationships) in people with Sexual Risk Behavior and Sexually Transmitted Infections, run by University of Illinois Chicago at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sexual Risk Behavior, Sexually Transmitted Infections, Unplanned Pregnancy
- What is being tested?
- Floreciendo (Foundations, Condoms & Contraception, Family Strengthening, and Gender & Relationships), Floreciendo (Foundations, Condoms & Contraception, and Family Strengthening) and Floreciendo (Foundations, Condoms & Contraception, Gender & Relationships)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 4 sitesUnited States
- Study dates
- 9 Mar 2024to 6 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Gads Hill Center
Chicago, Illinois, 60608
Expanded Mental Health Services of Chicago NFP
Chicago, Illinois, 60647
Centro Romero
Chicago, Illinois, 60660
Corazon Community Services
Cicero, Illinois, 60804
About this study
Official title: Evidence-based Sexual and Reproductive Health Intervention Using a Multiphase Optimization Strategy
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.
Read the 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).
- Being tested
- Floreciendo (Foundations, Condoms & Contraception, Family Strengthening, and Gender & Relationships), Floreciendo (Foundations, Condoms & Contraception, and Family Strengthening), Floreciendo (Foundations, Condoms & Contraception, Gender & Relationships), Floreciendo (Foundations, Family Strengthening, and Gender & Relationships), Floreciendo (Foundations and Condoms & Contraception)
- Keywords
- Sexual and reproductive health, Latina teens, Mother-daughter intervention
- Medical subject headings
- Sexually Transmitted Diseases, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Floreciendo (Foundations, Condoms & Contraception, Family Strengthening, and Gender & Relationships)Behavioural
- 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)Behavioural
- 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)Behavioural
- 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)Behavioural
- 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)Behavioural
- 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)Behavioural
- 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)Behavioural
- 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)Behavioural
- Foundations in sexual risk prevention: Covers key topics in sexual and reproductive health and helps participants develop an awareness of sexual behavior risks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Floreciendo (Foundations and Gender & Partner Relationships) |
| Foundations | Experimental | This arm receives the constant session (Foundations in Sexual Risk Prevention) only. Receives: Behavioral: Floreciendo (Foundations) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: 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
Measured: Immediately after completing the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start9 Mar 2024
- Primary completion6 Jun 2026
- Study completion6 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Risk BehaviorStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- 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").
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223165
- Sponsor's protocol ID
- 2022-0207
- Acronym
- Floreciendo
- Status last verified
- Aug 2026
- First submitted
- 4 Jan 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence-based Sexual and Reproductive Health Intervention Using a Multiphase Optimization Strategy
- ClinicalTrials.gov ID
- NCT06223165
- Acronym / sponsor ID
- Floreciendo / 2022-0207
- Keywords
- Sexual and reproductive health, Latina teens, Mother-daughter intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 9 Mar 2024 (actual)
- Primary completion
- 6 Jun 2026 (actual)
- Study completion
- 6 Jun 2026 (actual)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
- 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").
| Arm | Type | Receives |
|---|---|---|
| Foundations, Condoms & Contraception, Family Strengthening, and Gender & Relationships | Experimental | Behavioral: Floreciendo (Foundations, Condoms & Contraception, Family Strengthening, and Gender & Relationships)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. |
| Foundations, Condoms & Contraception, and Family Strengthening | Experimental | Behavioral: Floreciendo (Foundations, Condoms & Contraception, and Family Strengthening)This arm receives the constant session (Foundations in Sexual Risk Prevention) and two other workshop sessions: 1) Condoms \& Contraception and 2) Family Strengthening. |
| Foundations, Condoms & Contraception, Gender & Relationships | Experimental | Behavioral: Floreciendo (Foundations, Condoms & Contraception, Gender & Relationships)This arm receives the constant session (Foundations in Sexual Risk Prevention) and two other workshop sessions: 1) Condoms \& Contraception and 2) Gender \& Relationships. |
| Foundations, Family Strengthening, and Gender & Relationships | Experimental | Behavioral: Floreciendo (Foundations, Family Strengthening, and Gender & Relationships)This arm receives the constant session (Foundations in Sexual Risk Prevention) and two other workshop sessions: 1) Family Strengthening and 2) Gender \& Relationships. |
| Foundations and Condoms & Contraception | Experimental | Behavioral: Floreciendo (Foundations and Condoms & Contraception)This arm receives the constant session (Foundations in Sexual Risk Prevention) and one other workshop session: Condoms \& Contraception. |
| Foundations and Family Strengthening | Experimental | Behavioral: Floreciendo (Foundations and Family Strengthening)This arm receives the constant session (Foundations in Sexual Risk Prevention) and one other workshop session: Family Strengthening. |
| Foundations and Gender & Partner Relationships | Experimental | Behavioral: Floreciendo (Foundations and Gender & Partner Relationships)This arm receives the constant session (Foundations in Sexual Risk Prevention) and one other workshop session: Gender \& Relationships. |
| Foundations | Experimental | Behavioral: Floreciendo (Foundations)This arm receives the constant session (Foundations in Sexual Risk Prevention) only. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Floreciendo (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. | Behavioural | Foundations, Condoms & Contraception, Family Strengthening, and Gender & Relationships |
| Floreciendo (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. | Behavioural | Foundations, Condoms & Contraception, and Family Strengthening |
| Floreciendo (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. | Behavioural | Foundations, Condoms & Contraception, Gender & Relationships |
| Floreciendo (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. | Behavioural | Foundations, Family Strengthening, and Gender & Relationships |
| Floreciendo (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. | Behavioural | Foundations and Condoms & Contraception |
| Floreciendo (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. | Behavioural | Foundations and Family Strengthening |
| Floreciendo (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. | Behavioural | Foundations and Gender & Partner Relationships |
| Floreciendo (Foundations)• Foundations in sexual risk prevention: Covers key topics in sexual and reproductive health and helps participants develop an awareness of sexual behavior risks. | Behavioural | Foundations |
Primary outcome
Feasibility of factorial trial design
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Sexual Risk Behavior
Enrolling by invitationObservational study
Clinical Time and Temporal Dynamics Study (CLIN-TIME)
Longitudinal Studies, Prospective Studies
RecruitingPhase 2
Integrating PrEP Decision Making Into Counseling in Sexual and Reproductive Health Clinics
Sexual Risk Behavior for HIV-infection, Reproductive Health
Recruiting
CARRII Native Intervention Optimization Trial
Fetal Alcohol Spectrum Disorders, Pregnancy
Recruiting
WORTH Paths Intervention
Substance Use Disorder (SUD), Sexual and Reproductive Health
Active, not recruiting
Evaluation of an Adolescent Pregnancy Prevention Program; Relationship Smarts+ With Lessons From Mind Matters
Teen Pregnancy, Contraception Behavior
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Floreciendo (Foundations, Condoms & Contraception, Family Strengthening, and Gender & Relationships), Floreciendo (Foundations, Condoms & Contraception, and Family Strengthening) and Floreciendo (Foundations, Condoms & Contraception, Gender & Relationships) in people with Sexual Risk Behavior and Sexually Transmitted Infections, run by University of Illinois Chicago at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of factorial trial design (time frame: Through study completion (anticipated 2.5 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.