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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
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Guillermo Prado, University of Miami

Study Description
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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.

Condition or disease Intervention/treatment Phase
Depression Drug Use Behavioral: Families with Pride ("Familias con Orgullo") Not Applicable

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Guillermo Prado, PhD 305-284-2002 gprado@miami.edu
Contact: Yannine Estrada, PhD 305-284-6191 yestrada@miami.edu

Locations
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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         
Sponsors and Collaborators
University of Miami
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Guillermo Prado, PhD University of Miami
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guillermo Prado, University of Miami:
randomized controlled trial
Hispanic sexual minority youth
parent-centered
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms