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| Name | Class |
|---|---|
| Centro Romero | UNKNOWN |
| Expanded Mental Health Services of Chicago | UNKNOWN |
| Corazon Community Services | UNKNOWN |
| Gads Hill Center |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Floreciendo (Foundations, Condoms & Contraception, Family Strengthening, and Gender & Relationships) | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Exploratory primary effectiveness outcome: Sexual risk behavior | Proportion of teens who report risky sexual behavior at baseline and follow-up (self-reported using AIDS Risk Behavior Assessment) | Baseline to follow-up |
| Exploratory secondary effectiveness outcome: sexually transmitted infections |
Inclusion criteria for teens:
Inclusion criteria for female caregivers:
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.
Teens and caregivers must identify as female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kate Merrill, PhD | Contact | 312-413-0386 | kgm@uic.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gads Hill Center | Recruiting | Chicago | Illinois | 60608 | United States |
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| UNKNOWN |
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").
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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.
| Foundations and Condoms & Contraception | Experimental | This arm receives the constant session (Foundations in Sexual Risk Prevention) and one other workshop session: Condoms & Contraception. |
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| Foundations and Family Strengthening | Experimental | This arm receives the constant session (Foundations in Sexual Risk Prevention) and one other workshop session: Family Strengthening. |
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| Foundations and Gender & Partner Relationships | Experimental | This arm receives the constant session (Foundations in Sexual Risk Prevention) and one other workshop session: Gender & Relationships. |
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| Foundations | Experimental | This arm receives the constant session (Foundations in Sexual Risk Prevention) only. |
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| Floreciendo (Foundations, Condoms & Contraception, and Family Strengthening) | Behavioral |
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| Floreciendo (Foundations, Condoms & Contraception, Gender & Relationships) | Behavioral |
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| Floreciendo (Foundations, Family Strengthening, and Gender & Relationships) | Behavioral |
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| Floreciendo (Foundations and Condoms & Contraception) | Behavioral |
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| Floreciendo (Foundations and Family Strengthening) | Behavioral |
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| Floreciendo (Foundations and Gender & Partner Relationships) | Behavioral |
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| 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. |
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Proportion of teens with a sexually transmitted infection (STI) at baseline and follow-up. |
| Baseline to follow-up |
| Exploratory secondary effectiveness outcome: Unplanned pregnancy | Proportion of teens with an unplanned pregnancy at baseline and follow-up (self-reported) | Baseline to follow-up |
| Exploratory implementation outcomes | We will explore feasibility of implementing the Floreciendo intervention, appropriateness, adoption, sustainability, cost, and fidelity. | Through study completion (anticipated 2.5 years) |
| Expanded Mental Health Services of Chicago NFP | Recruiting | Chicago | Illinois | 60647 | United States |
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| Centro Romero | Recruiting | Chicago | Illinois | 60660 | United States |
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| Corazon Community Services | Recruiting | Cicero | Illinois | 60804 | United States |
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| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| D003075 | Coitus |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D005582 | Foundations |
| D017280 | Condoms |
| D003267 | Contraception |
| D012723 | Sex |
| D001244 | Association |
| ID | Term |
|---|---|
| D005378 | Financial Support |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D009939 | Organizations, Nonprofit |
| D009938 | Organizations |
| D003275 | Contraceptive Devices, Male |
| D003273 | Contraceptive Devices |
| D004864 | Equipment and Supplies |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
| D013811 | Psychotherapeutic Processes |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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