Families With Pride ("Familias Con Orgullo").
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-19
SponsorUniversity of Miami
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Adolescent identifies as transgender.
Trial design
Design model
Parallel
Treatments tested in this trial
Families with Pride ("Familias con Orgullo")
BehavioralFamilies 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.
Treatment groups
306 Participants
are divided into 2 treatment groupsGroup A: Families with Pride ("Familias con Orgullo")Experimental treatment 1 intervention
Group B: Community PracticeNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline up to 30 months2
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.
Time frame
Baseline up to 30 months3
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.
Time frame
Baseline up to 30 monthsSecondary outcomes
1
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.
Time frame
Baseline up to 30 months2
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.
Time frame
Baseline up to 30 months3
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.
Time frame
Baseline up to 30 months4
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.
Time frame
Baseline up to 30 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Miami
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov