DepressionNCT06057337
Families With Pride ("Familias Con Orgullo").
A study testing Families with Pride ("Familias con Orgullo") in people with Depression and Drug Use, run by University of Miami at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Depression, Drug Use
- What is being tested?
- Families with Pride ("Familias con Orgullo")
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2024to 28 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Adolescent identifies as transgender.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Coral Gables, Florida, 33146
Guillermo Prado, PhD, 305-284-2002, gprado@miami.edu
Guillermo Prado, PhD
About this study
Official title: Promoting Health and Reducing Risk Among Hispanic Sexual Minority Youth and Their Families
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.
- Conditions
- Depression, Drug Use
- Being tested
- Families with Pride ("Familias con Orgullo")
- Keywords
- randomized controlled trial, Hispanic sexual minority youth, parent-centered
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Families with Pride ("Familias con Orgullo")Behavioural
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 group | Role | What they receive |
|---|---|---|
| Families with Pride ("Familias con Orgullo") | Experimental | 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. Receives: Behavioral: Families with Pride ("Familias con Orgullo") |
| Community Practice | No intervention | In this condition, participants will not receive an intervention, only the standard of care services for up to 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to 30 months
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.
Measured: Baseline up to 30 months
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.
Measured: Baseline up to 30 months
Secondary outcomes (6)
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.
Measured: Baseline up to 30 months
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.
Measured: Baseline up to 30 months
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.
Measured: Baseline up to 30 months
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.
Measured: Baseline up to 30 months
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.
Measured: Baseline up to 30 months
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.
Measured: Baseline up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start11 Mar 2024
- Primary completion28 Dec 2029 (estimated)
- Study completion28 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Guillermo Prado, University of Miami
- Investigators
- Guillermo Prado, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057337
- Sponsor's protocol ID
- 20230372
- Other IDs
- 1R01MD017588-01A1
- Status last verified
- May 2026
- First submitted
- 14 Jul 2023
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lozano A, Estrada Y, Scott D, Tapia MI, Santos HP Jr, Carrico AW, Zolobczuk J, Manker A, Prado G. Familias con Orgullo: Study protocol for an efficacy study of a family-based intervention for Hispanic sexual minority youth. PLoS One. 2023 Dec 15;18(12):e0295683. doi: 10.1371/journal.pone.0295683. eCollection 2023.
PubMed 38100451
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Health and Reducing Risk Among Hispanic Sexual Minority Youth and Their Families
- ClinicalTrials.gov ID
- NCT06057337
- Acronym / sponsor ID
- 20230372
- Conditions
- Depression, Drug Use
- Keywords
- randomized controlled trial, Hispanic sexual minority youth, parent-centered
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 28 Dec 2029 (estimated)
- Study completion
- 28 Dec 2029 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Families with Pride ("Familias con Orgullo") | Experimental | Behavioral: 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. |
| Community Practice | No intervention | –In this condition, participants will not receive an intervention, only the standard of care services for up to 12 weeks. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Adolescent identifies as transgender.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Families with Pride ("Familias con Orgullo") |
Primary outcome
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.
6 secondary outcomes
Change in unprotected sexual behavior
Time frame: Baseline up to 30 months
Change in Family Functioning as assessed by the Parenting Practices Questionnaire
Time frame: Baseline up to 30 months
Change in Family Functioning as assessed by the Parent-Adolescent Communication Scale
Time frame: Baseline up to 30 months
Changes in Adolescent Stress as assessed by the Perceived Stress Scale
Time frame: Baseline up to 30 months
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 Sexual Minority Stress as assessed by the Sexual Minority Adolescent Stress Scale
Time frame: Baseline up to 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Derived from this study: PubMed 38100451Lozano A, Estrada Y, Scott D, Tapia MI, Santos HP Jr, Carrico AW, Zolobczuk J, Manker A, Prado G. Familias con Orgullo: Study protocol for an efficacy study of a family-based intervention for Hispanic sexual minority youth. PLoS One. 2023 Dec 15;18(12):e0295683. doi: 10.1371/journal.pone.0295683. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillermo Prado, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Families with Pride ("Familias con Orgullo") in people with Depression and Drug Use, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillermo Prado, PhD (305-284-2002, gprado@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression symptoms (time frame: Baseline up to 30 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06057337, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.