The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Families With Pride ("Familias Con Orgullo").

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 14, 2023
First Posted Date  ICMJE September 28, 2023
Last Update Posted Date March 15, 2024
Actual Study Start Date  ICMJE March 11, 2024
Estimated Primary Completion Date December 31, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2023)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2023)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Families With Pride ("Familias Con Orgullo").
Official Title  ICMJE Promoting Health and Reducing Risk Among Hispanic Sexual Minority Youth and Their Families
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Depression
  • Drug Use
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Families with Pride ("Familias con Orgullo")
  • No Intervention: Community Practice
    In this condition, participants will not receive an intervention, only the standard of care services for up to 12 weeks.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 26, 2023)		 306
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2027
Estimated Primary Completion Date December 31, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: Adolescent does not identify as transgender.
Ages  ICMJE 13 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Guillermo Prado, PhD 305-284-2002 gprado@miami.edu
Contact: Yannine Estrada, PhD 305-284-6191 yestrada@miami.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06057337
Other Study ID Numbers  ICMJE 20230372
1R01MD017588-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Guillermo Prado, University of Miami
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Miami
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institute on Minority Health and Health Disparities (NIMHD)
Investigators  ICMJE
Principal Investigator: Guillermo Prado, PhD University of Miami
PRS Account University of Miami
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP