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Families With Pride ("Familias Con Orgullo").

Primary Purpose

Depression, Drug Use

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Families with Pride ("Familias con Orgullo")
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring randomized controlled trial, Hispanic sexual minority youth, parent-centered

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Families with Pride ("Familias con Orgullo")

Community Practice

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Change in unprotected sexual behavior
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
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
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
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
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
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.

Full Information

First Posted
July 14, 2023
Last Updated
September 26, 2023
Sponsor
University of Miami
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT06057337
Brief Title
Families With Pride ("Familias Con Orgullo").
Official Title
Promoting Health and Reducing Risk Among Hispanic Sexual Minority Youth and Their Families
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
December 31, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Drug Use
Keywords
randomized controlled trial, Hispanic sexual minority youth, parent-centered

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
306 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Families with Pride ("Familias con Orgullo")
Arm Type
Experimental
Arm Description
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.
Arm Title
Community Practice
Arm Type
No Intervention
Arm Description
In this condition, participants will not receive an intervention, only the standard of care services for up to 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Families with Pride ("Familias con Orgullo")
Intervention Description
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 Information:
Title
Change in depression symptoms
Description
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.
Time Frame
Baseline up to 30 months
Title
Change in frequency of drug use
Description
Change in drug use will be reported as the number of days of use over the previous 90 days at each timepoint.
Time Frame
Baseline up to 30 months
Title
Change in quantity of drug use
Description
Change in drug use will be reported as the amount of use over the previous 90 days at each timepoint.
Time Frame
Baseline up to 30 months
Secondary Outcome Measure Information:
Title
Change in unprotected sexual behavior
Description
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.
Time Frame
Baseline up to 30 months
Title
Change in Family Functioning as assessed by the Parenting Practices Questionnaire
Description
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.
Time Frame
Baseline up to 30 months
Title
Change in Family Functioning as assessed by the Parent-Adolescent Communication Scale
Description
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.
Time Frame
Baseline up to 30 months
Title
Changes in Adolescent Stress as assessed by the Perceived Stress Scale
Description
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.
Time Frame
Baseline up to 30 months
Title
Changes in Parent Acceptance of Adolescents Sexual Orientation as assessed by the Perceived Parental Reactions Scale
Description
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.
Time Frame
Baseline up to 30 months
Title
Changes in Sexual Minority Stress as assessed by the Sexual Minority Adolescent Stress Scale
Description
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.
Time Frame
Baseline up to 30 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Adolescent does not identify as transgender.
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillermo Prado, PhD
Phone
305-284-2002
Email
gprado@miami.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Yannine Estrada, PhD
Phone
305-284-6191
Email
yestrada@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillermo Prado, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillermo Prado, PhD
Phone
305-284-2002
Email
gprado@miami.edu
First Name & Middle Initial & Last Name & Degree
Guillermo Prado, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Families With Pride ("Familias Con Orgullo").

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