Families With Pride ("Familias Con Orgullo").

Promoting Health and Reducing Risk Among Hispanic Sexual Minority Youth and Their Families

This study will evaluate the effects of a parenting intervention for Hispanic sexual minority youth in preventing/reducing drug use and depressive symptoms. It will also examine whether the intervention improves parent social support for the adolescent, parent acceptance, family functioning, and whether it reduces general stress and stress associated with being a Hispanic sexual minority.

Study Overview

• Status: Recruiting
• Conditions: Depression; Drug Use
• Intervention / Treatment: Behavioral: Families with Pride ("Familias con Orgullo")

• Study Type: Interventional
• Enrollment (Estimated): 306
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guillermo Prado, PhD; Phone Number: 305-284-2002; Email: gprado@miami.edu
• Study Contact Backup: Name: Yannine Estrada, PhD; Phone Number: 305-284-6191; Email: yestrada@miami.edu

Study Locations

• United States
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Recruiting
      • University of Miami
      • Contact: Guillermo Prado, PhD; Phone Number: 305-284-2002; Email: gprado@miami.edu
      • Principal Investigator: Guillermo Prado, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Youth, 13 - 19, who report at least one of the following: a) identify as gay, lesbian, or bisexual, b) reports same sex attraction, or c) reports same-sex sexual behavior.
• Adolescent has 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.

Exclusion Criteria:

• Adolescent identifies as transgender.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in depression symptoms	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.	Baseline up to 30 months
Change in frequency of drug use	Change in drug use will be reported as the number of days of use over the previous 90 days at each timepoint.	Baseline up to 30 months
Change in quantity of drug use	Change in drug use will be reported as the amount of use over the previous 90 days at each timepoint.	Baseline up to 30 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in unprotected sexual behavior	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.	Baseline up to 30 months
Change in Family Functioning as assessed by the Parenting Practices Questionnaire	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.	Baseline up to 30 months
Change in Family Functioning as assessed by the Parent-Adolescent Communication Scale	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.	Baseline up to 30 months
Changes in Adolescent Stress as assessed by the Perceived Stress Scale	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.	Baseline up to 30 months
Changes in Parent Acceptance of Adolescents Sexual Orientation as assessed by the Perceived Parental Reactions Scale	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.	Baseline up to 30 months
Changes in Sexual Minority Stress as assessed by the Sexual Minority Adolescent Stress Scale	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.	Baseline up to 30 months

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Guillermo Prado, PhD, University of Miami

Publications and helpful links

General Publications

• Lozano A, Estrada Y, Scott D, Tapia MI, Santos HP Jr, Carrico AW, Zolobczuk J, Manker A, Prado G. Familias con Orgullo: Study protocol for an efficacy study of a family-based intervention for Hispanic sexual minority youth. PLoS One. 2023 Dec 15;18(12):e0295683. doi: 10.1371/journal.pone.0295683. eCollection 2023.

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2024
• Primary Completion (Estimated): December 28, 2029
• Study Completion (Estimated): December 28, 2029

Study Registration Dates

• First Submitted: July 14, 2023
• First Submitted That Met QC Criteria: September 26, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trial; parent-centered; Hispanic sexual minority youth
• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression
• Other Study ID Numbers: 20230372; 1R01MD017588-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No