Recruiting

Observational Study

Sponsor:

University of Miami

Code:

NCT06057337

Conditions

Depression

Drug Use

Eligibility Criteria

Sex: All

Age: 13 - 19

Healthy Volunteers: Not accepted

Interventions

Families with Pride ("Familias con Orgullo")

Study Details

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

Study ID

NCT06057337

Start date

Mar 11, 2024

Status verified date

May, 2026

Completion date

Dec 28, 2029

Anticipated

Primary completion date

Dec 28, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 19

Healthy Volunteers: Not accepted

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 Design

Enrollment

306 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

no intervention: Community Practice

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")

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.

Primary outcome measure

  • Change in depression symptoms [ Time Frame: Baseline up to 30 months ]
  • Change in frequency of drug use [ Time Frame: Baseline up to 30 months ]
  • Change in quantity of drug use [ Time Frame: Baseline up to 30 months ]

Central Contacts and Locations

Central contacts

Guillermo Prado, PhD

305-284-2002gprado@miami.edu

Yannine Estrada, PhD

305-284-6191yestrada@miami.edu

Locations

University of Miami

Recruiting

Coral Gables, Florida, United States, 33146

Contacts

Guillermo Prado, PhD

305-284-2002gprado@miami.edu

Principal Investigator:

Guillermo Prado, PhD

More Information

Sponsor

University of Miami

Last update posted

May 13, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-05-13.