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Recruiting NCT06057337

Families With Pride ("Familias Con Orgullo").

No phase Interventional Depression Drug Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Families with Pride ("Familias con Orgullo").
Who it may be relevant to
Registry conditions: Depression, Drug Use. Basic parameters: 13 years — 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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 la

Primary outcome measures

  • 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]
Secondary outcome measures (6)
  • Change in unprotected sexual behavior [Time frame: Baseline up to 30 months]
  • Change in Family Functioning as assessed by the Parenting Practices Questionnaire [Time frame: Baseline up to 30 months]
  • Change in Family Functioning as assessed by the Parent-Adolescent Communication Scale [Time frame: Baseline up to 30 months]
  • Changes in Adolescent Stress as assessed by the Perceived Stress Scale [Time frame: Baseline up to 30 months]
  • 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 Sexual Minority Stress as assessed by the Sexual Minority Adolescent Stress Scale [Time frame: Baseline up to 30 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Miami — Coral Gables

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. PMID 38100451

Identifiers

NCT: NCT06057337 · 20230372 · 1R01MD017588-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗