Families With Pride ("Familias Con Orgullo").

NCT06057337 | Recruiting

• 2 other identifiers: 202303721R01MD017588-01A1
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression; Drug Use

Keywords

randomized controlled trial; Hispanic sexual minority youth; parent-centered

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Change in unprotected sexual behavior

  Baseline up to 30 months

• Change in Family Functioning as assessed by the Parenting Practices Questionnaire

  Baseline up to 30 months

• Change in Family Functioning as assessed by the Parent-Adolescent Communication Scale

  Baseline up to 30 months

• Changes in Adolescent Stress as assessed by the Perceived Stress Scale

  Baseline up to 30 months

• Changes in Parent Acceptance of Adolescents Sexual Orientation as assessed by the Perceived Parental Reactions Scale

  Baseline up to 30 months

Study Arms (2)

Families with Pride ("Familias con Orgullo")

EXPERIMENTAL

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")

Community Practice

NO INTERVENTION

In this condition, participants will not receive an intervention, only the standard of care services for up to 12 weeks.

Interventions

Families with Pride ("Familias con Orgullo") BEHAVIORAL

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.

Families with Pride ("Familias con Orgullo")

Eligibility Criteria

• Age: 13 Years - 19 Years
• Gender Eligibility Details: Adolescent does not identify as transgender.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Youth, 13 - 19, 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

You may not qualify if:

• Adolescent identifies as transgender.
• Family plans to move out of South Florida during the study period

Sponsors & Collaborators

• University of Miami: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of Miami

Coral Gables, Florida, 33146, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 38100451 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Guillermo Prado, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillermo Prado, PhD

CONTACT

305-284-2002; gprado@miami.edu

Yannine Estrada, PhD

CONTACT

305-284-6191; yestrada@miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: September 28, 2023
• Study Start: March 11, 2024
• Primary Completion (Estimated): December 28, 2029
• Study Completion (Estimated): December 28, 2029
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)