Families With Pride ("Familias Con Orgullo").

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06057337
• Other study ID #: 20230372
• Secondary ID: 1R01MD017588-01A
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: University of Miami
• Contact: Guillermo Prado, PhD
• Phone: 305-284-2002
• Email: gprado[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 306
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Drug Use

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami	Coral Gables	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline up to 30 months
Primary	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.	Baseline up to 30 months
Primary	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.	Baseline up to 30 months
Secondary	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.	Baseline up to 30 months
Secondary	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.	Baseline up to 30 months
Secondary	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.	Baseline up to 30 months
Secondary	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.	Baseline up to 30 months
Secondary	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.	Baseline up to 30 months
Secondary	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.	Baseline up to 30 months