Families with Pride Program for Substance Use and Depression

Overseen By Yannine Estrada, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Transgender, Moving out of South Florida

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

306 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special program, Families with Pride ("Familias con Orgullo"), can help Hispanic sexual minority youth reduce drug use and ease depression. The program includes group sessions for parents and adolescents to enhance family support and reduce stress. It targets families in South Florida with Hispanic teens, aged 13-19, who identify as gay, lesbian, or bisexual and have shared this with at least one parent.

As an unphased trial, participants contribute to valuable research that may enhance support for Hispanic sexual minority youth.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this parenting intervention is safe for Hispanic sexual minority youth?

Research has shown that the Families with Pride program, also known as Familias con Orgullo, may help reduce drug use and feelings of depression among Latinx youth who identify as sexual minorities. An earlier study found that this family-focused program improved family cooperation.

Regarding safety, the program includes group sessions and family meetings, which do not carry the same risks as a medication trial. No reports of negative effects from the sessions themselves have emerged. Participants generally handle the program well without any problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Families with Pride program is unique because it combines group sessions for both parents and adolescents, along with family sessions, to address substance use and depression. Unlike traditional individual therapy or medication, this program emphasizes family dynamics and the role of supportive relationships in recovery. Researchers are excited about this approach because it seeks to foster a more holistic and inclusive environment for change, which could lead to more sustainable outcomes for both parents and adolescents dealing with these challenges.

What evidence suggests that the Families with Pride program is effective for reducing substance use and depression?

Research has shown that the "Families with Pride" (Familias con Orgullo) program, which participants in this trial may receive, may benefit Hispanic LGBTQ+ youth. A small study found that it could lower drug use and reduce feelings of depression in these young people. The program also aims to enhance family cooperation, fostering a more supportive home environment. Early results suggest it can increase parental support and make families more accepting. These positive changes likely reduce stress for both parents and teens. Overall, initial studies highlight the program's potential to improve well-being in the community. ^{1 4 6 7 8}

Who Is on the Research Team?

Guillermo Prado, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for Hispanic sexual minority youth aged 13-17 living in South Florida who have disclosed their status to a parent. It's open to families where at least one parent identifies as Hispanic and agrees to participate. Families planning to move from South Florida or transgender adolescents are excluded.

Inclusion Criteria

I am a teen, 13-17, and identify as gay, lesbian, bisexual, or have had same-sex experiences.

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)

Exclusion Criteria

Family plans to move out of South Florida during the study period

I identify as transgender.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Families with Pride (Familias con Orgullo) intervention, consisting of seven multi parent group sessions, three multi adolescent group sessions, and four family sessions over 12 weeks

12 weeks

11 sessions for parents, 7 sessions for adolescents

Community Practice

Participants receive standard of care services for up to 12 weeks

12 weeks

Follow-up

Participants are monitored for changes in drug use, depression symptoms, and family functioning

30 months

What Are the Treatments Tested in This Trial?

Interventions

• Families with Pride ("Familias con Orgullo")

Trial Overview The 'Families With Pride' intervention aims to prevent/reduce drug use and depression among Hispanic sexual minority youth. It will test if the program enhances family support, acceptance, functioning, and reduces stress related to being a Hispanic sexual minority.

How Is the Trial Designed?

Group I: Families with Pride ("Familias con Orgullo") Experimental Treatment 1 Intervention

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.

Group II: Community Practice Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

A qualitative study involving 101 participants revealed that affected family members (AFMs) of individuals with substance use disorder (SUD) often feel isolated and unsupported, highlighting a critical gap in social support networks.

The study identified three main themes reflecting the AFMs' experiences: feelings of loneliness, a lack of understanding from others, and social withdrawal, emphasizing the need for targeted support programs to enhance the well-being of AFMs and improve family-centered care in nursing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Affected family members social support experiences when assisting an individual with substance use disorder. Kane, EM., Snethen, JA., Gwon, SH., et al.[2023]

A family-centered empowerment program significantly improved health-promoting lifestyles and health-related quality of life (QoL) among methamphetamine users and their families, as shown in a randomized clinical trial with 285 participants.

The intervention led to notable increases in self-efficacy, perceived social support, and other health promotion constructs, indicating that involving family members in the recovery process can enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Educational Intervention on Health-Promoting Lifestyle and Health-Related Life quality of Methamphetamine Users and Their Families: a Randomized Clinical Trial. Ghasemi, A., Estebsari, F., Bastaminia, A., et al.[2020]

School-based prevention programs that utilize interactive methods, such as peer discussions and role-playing, have been shown to effectively reduce stimulant use among students.

Family-based programs, mass media campaigns, and community interventions are promising strategies for prevention, but require further research before they can be widely implemented.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effects of preventative interventions targeting the use of stimulants]. Cuijpers, P.[2017]

The <<Familias que Funcionan>> program, implemented in four secondary schools with 380 students in Asturias, effectively reduced adolescent drug use over a two-year follow-up period, showing significant decreases in drug use rates.

Consistent attendance in the program also positively impacted certain family risk factors associated with drug use, indicating that family involvement is crucial in prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Family-based drug use prevention: the "Familias que Funcionan" ["Families that Work"] program]. Errasti Pérez, JM., Al-Halabí Díaz, S., Secades Villa, R., et al.[2019]

Familias Unidas is a parent-centered intervention specifically designed for Hispanic youth to help reduce substance use and HIV-related health disparities.

The program is grounded in a strong theoretical framework and supported by empirical research, demonstrating its effectiveness in addressing these critical health issues within the Hispanic community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Substance Use and HIV Health Disparities among Hispanic Youth in the U.S.A.: The Familias Unidas Program of Research. Prado, G., Pantin, H.[2021]

In a study of 57 opiate misusers undergoing inpatient detoxification, poorer family functioning in problem solving and roles increased the likelihood of patients leaving the treatment against medical advice.

Conversely, better family communication and behavioral control were linked to a lower likelihood of premature discharge, suggesting that family dynamics play a crucial role in the treatment process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opiate withdrawal outcome: the predictive ability of admission measures from the family assessment device (F.A.D.) Murphy, PN., Bentall, RP.[2019]

The shortened 6-week version of Familias Unidas effectively reduced sexual initiation rates among Latino adolescents, with only 34% initiating sex compared to 55% in the control group after 24 months.

The intervention was particularly effective in decreasing substance use initiation among girls (30.4% vs. 64.0%) and reducing unsafe sex among younger adolescents (15 years or younger), indicating that targeted approaches can enhance intervention efficacy for specific subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Brief Intervention to Reduce Substance Use and Human Immunodeficiency Virus Infection Risk Among Latino Youth. Estrada, Y., Rosen, A., Huang, S., et al.[2021]

Family involvement in addiction treatment can significantly improve outcomes, including treatment entry and completion, yet current services often focus on individuals rather than families.

This scoping review aims to identify the extent and nature of existing evidence on family interventions in addiction treatment, highlighting gaps to inform future research and best practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-focused practices in addictions: a scoping review protocol. Kourgiantakis, T., Ashcroft, R.[2018]

A randomized controlled trial compared a comprehensive family intervention for clients with dual disorders to a shorter psychoeducational program, showing that family engagement is crucial for treatment success, with initial engagement rates of 88% and 84% respectively.

Long-term retention in these programs was lower (61% for the comprehensive program and 55% for the psychoeducational program), indicating that addressing family dynamics and the impact of substance abuse on relationships could enhance participation and effectiveness of family interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family intervention for co-occurring substance use and severe psychiatric disorders: participant characteristics and correlates of initial engagement and more extended exposure in a randomized controlled trial. Mueser, KT., Glynn, SM., Cather, C., et al.[2021]

A study involving 32 family members of drug users found that both community reinforcement training and a 12-step self-help group led to similar improvements in the mood and social functioning of the family members over 10 weeks.

However, the community reinforcement training was more effective in keeping family members engaged in treatment and encouraging drug users to seek treatment, highlighting its potential as a more supportive intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community reinforcement training for family and significant others of drug abusers: a unilateral intervention to increase treatment entry of drug users. Kirby, KC., Marlowe, DB., Festinger, DS., et al.[2019]

Familias con Orgullo is a newly developed family-based intervention aimed at reducing substance use, risky sexual behavior, and depressive symptoms among Latinx sexual minority youth (LSMY), based on qualitative feedback from 24 participants (12 parents and 12 LSMY).

The intervention emphasizes the importance of a safe communication space, parental acceptance, and culturally relevant content, leading to positive feedback from families regarding improved relationships and increased LGBTQ knowledge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a family-based preventive intervention for Latinx sexual minority youth and their parents. Lozano, A., Estrada, Y., Tapia, MI., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38100451/

Familias con Orgullo: Study protocol for an efficacy ... - PubMed Outcomes will be measured at baseline and 6-, 18-, and 30-months post-baseline. The goals of this study are to evaluate whether the Familias con ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11519147/

Familias con Orgullo: Pilot Study of a Family Intervention for ... FcO holds promise for reducing drug use and depressive symptoms and improving family functioning among Latinx SMY.

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0295683

Familias con Orgullo: Study protocol for an efficacy study of a ... Outcomes will be measured at baseline and 6-, 18-, and 30-months post-baseline. The goals of this study are to evaluate whether the Familias con ...

4. researchgate.net researchgate.net/publication/376572257_Familias_con_Orgullo_Study_protocol_for_an_efficacy_study_of_a_family-based_intervention_for_Hispanic_sexual_minority_youth

(PDF) Familias con Orgullo: Study protocol for an efficacy ... Outcomes will be measured at baseline and 6-, 18-, and 30-months post-baseline. The goals of this study are to evaluate whether the Familias con ...

5. ctv.veeva.com ctv.veeva.com/study/families-with-pride-familias-con-orgullo

Families With Pride ("Familias Con Orgullo"). This study will evaluate the effects of a parenting intervention for Hispanic sexual minority youth in preventing/reducing drug use and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10723681/

Familias con Orgullo: Study protocol for an efficacy study of a ... We hypothesize that Familias con Orgullo will be efficacious, compared to community practice, in decreasing past 90-day drug use frequency and ...

7. withpower.com withpower.com/trial/phase-depression-2024-f2e94

Families with Pride Program for Substance Use and Depression This study will evaluate the effects of a parenting intervention for Hispanic sexual minority youth in preventing/reducing drug use and depressive symptoms.

8. awspntest.apa.org awspntest.apa.org/fulltext/2022-00102-001.pdf?sr=1

Development of a Family-Based Preventive Intervention for ... This qualitative study describes the development of Familias con Orgullo (Families with Pride), a family-based intervention to prevent/reduce substance use, ...