Families With Pride ("Familias Con Orgullo").
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ClinicalTrials.gov Identifier: NCT06057337 |
Recruitment Status :
Recruiting
First Posted : September 28, 2023
Last Update Posted : March 15, 2024
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Condition or disease | Intervention/treatment | Phase |
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Depression Drug Use | Behavioral: Families with Pride ("Familias con Orgullo") | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 306 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Promoting Health and Reducing Risk Among Hispanic Sexual Minority Youth and Their Families |
Actual Study Start Date : | March 11, 2024 |
Estimated Primary Completion Date : | December 31, 2027 |
Estimated Study Completion Date : | December 31, 2027 |
Arm | Intervention/treatment |
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Experimental: Families with Pride ("Familias con Orgullo")
Participants in this group will receive the Families with Pride (Familias con Orgullo) intervention. The intervention consists of seven multi parent group sessions, three multi adolescent group sessions, and four family sessions (parents participant in a total of 11 sessions, adolescents participate in a total of seven sessions) that will be delivered by a facilitator to the parent-child dyad across 12 weeks.
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Behavioral: Families with Pride ("Familias con Orgullo")
Families with Pride (Familias con Orgullo) aims to prevent the co-occurring epidemics of drug use and depression in Hispanic sexual minority youth. It focuses on improving parent support for the adolescent, parent acceptance of the adolescent, family functioning (e.g., communication), and decreasing stress and sexual minority stress. The program consists of 11 weekly, in-person sessions: 7 parent group sessions, 3 concurrent adolescent group sessions, both lasting two hours, 4 family sessions lasting 1 hour in either Spanish or English, depending on participant language preference. In the parent group sessions, parents come together to foster social support, family functioning, and increase parental support and acceptance for the adolescent. In the adolescent sessions, adolescents build skills in confronting and managing stressors related to being a sexual minority. |
No Intervention: Community Practice
In this condition, participants will not receive an intervention, only the standard of care services for up to 12 weeks.
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- Change in depression symptoms [ Time Frame: Baseline up to 30 months ]Change in depression symptoms will be assessed with the Center for Epidemiological Studies Depression Scale. Scores range from 0 to 60 with higher scores indicating the presence of more symptoms.
- Change in frequency of drug use [ Time Frame: Baseline up to 30 months ]Change in drug use will be reported as the number of days of use over the previous 90 days at each timepoint.
- Change in quantity of drug use [ Time Frame: Baseline up to 30 months ]Change in drug use will be reported as the amount of use over the previous 90 days at each timepoint.
- Change in unprotected sexual behavior [ Time Frame: Baseline up to 30 months ]Change in unprotected sexual behavior will be reported as number of days of sex without a condom as reported over the last 90 days at each timepoint.
- Change in Family Functioning as assessed by the Parenting Practices Questionnaire [ Time Frame: Baseline up to 30 months ]Change in family functioning will be reported using nine items from the Parenting Practices Questionnaire . Response range varies based on questions, but most response items range from 0 to 4 with higher values indicating better parenting. Scores range from 0 to 36.
- Change in Family Functioning as assessed by the Parent-Adolescent Communication Scale [ Time Frame: Baseline up to 30 months ]Change in family functioning will be reported using the Parent-Adolescent Communication Scale. The Parent-Adolescent Communication Scale is a 20-item questionnaire with a total score ranging from 20 to 100 with higher scores indicating better communication.
- Changes in Adolescent Stress as assessed by the Perceived Stress Scale [ Time Frame: Baseline up to 30 months ]Change in adolescent stress will be reported using the Perceived Stress Scale. The Perceived Stress Scale is a 10-item measure with response items ranging from 0 to 4. Higher scores indicate more stress. Scores range from 0 to 40.
- Changes in Parent Acceptance of Adolescents Sexual Orientation as assessed by the Perceived Parental Reactions Scale [ Time Frame: Baseline up to 30 months ]Changes in parent acceptance of adolescents sexual orientation will be reported using the Perceived Parental Reactions Scale. The Perceived Parental Reactions Scale is a 32-item measure with responses ranging from 1 to 5. Higher scores indicate more negative perceptions of their parents' reactions, with scores ranging from 32 to 160.
- Changes in Sexual Minority Stress as assessed by the Sexual Minority Adolescent Stress Scale [ Time Frame: Baseline up to 30 months ]Change in adolescent sexual minority stress will be reported using the Sexual Minority Adolescent Stress Scale. The Sexual Minority Adolescent Stress Scale is a 54-item measure with higher scores indicating more sexual minority stress. Scores range from 1 to 54.
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Ages Eligible for Study: | 13 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Adolescent does not identify as transgender. |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Youth, 13 - 17, who report at least one of the following: a) identify as gay, lesbian, or bisexual, or b) reports same-sex sexual behavior.
- Adolescent has their disclosed their sexual minority status to at least one parent.
- Adolescent is of Hispanic immigrant origin, defined by having at least one parent that self-identifies as Hispanic (English and Spanish speaking Hispanics can participate in the study).
- Adolescent lives with an adult parent who is willing to participate.
- Family lives in South Florida
Exclusion Criteria:
- Adolescent identifies as transgender.
- Family plans to move out of South Florida during the study period
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06057337
Contact: Guillermo Prado, PhD | 305-284-2002 | gprado@miami.edu | |
Contact: Yannine Estrada, PhD | 305-284-6191 | yestrada@miami.edu |
United States, Florida | |
University of Miami | Recruiting |
Coral Gables, Florida, United States, 33146 | |
Contact: Guillermo Prado, PhD 305-284-2002 gprado@miami.edu | |
Principal Investigator: Guillermo Prado, PhD |
Principal Investigator: | Guillermo Prado, PhD | University of Miami |
Responsible Party: | Guillermo Prado, Professor, University of Miami |
ClinicalTrials.gov Identifier: | NCT06057337 |
Other Study ID Numbers: |
20230372 1R01MD017588-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | September 28, 2023 Key Record Dates |
Last Update Posted: | March 15, 2024 |
Last Verified: | March 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
randomized controlled trial Hispanic sexual minority youth parent-centered |
Depression Behavioral Symptoms |