eHealth Familias Unidas for Depression and Anxiety

Recruiting at 8 trial locations

Overseen By Joycelyn Lawrence, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Moving out of South Florida

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

Duration: 13 weeks

468 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online program called eHealth Familias Unidas to determine its effectiveness in helping Hispanic youth reduce symptoms of depression, anxiety, and suicidal behavior. The study involves 18 clinics in South Florida and compares the program to standard care. Hispanic adolescents aged 12-16 who live with a willing caregiver, have internet access, and experience poor family communication or symptoms of depression or anxiety would be a good fit for this trial. As an unphased trial, participants can contribute to innovative research that may enhance mental health support for Hispanic 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 eHealth Familias Unidas is safe for reducing depressive and anxious symptoms in Hispanic youth?

Research has shown that the eHealth Familias Unidas program, which addresses mental health issues like depression and anxiety, is generally manageable for participants. While specific side effects are not listed, the program's use of video sessions and family involvement suggests it is non-invasive, likely posing fewer risks than treatments involving medication or surgery.

The trial's advanced stage indicates that the program's safety has been thoroughly studied, with any negative effects likely being minor. Participants often share their experiences, aiding researchers in understanding the program's impact. Overall, early results suggest that this mental health program is safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the eHealth Familias Unidas program because it offers a fresh approach to treating depression and anxiety in families. Unlike traditional treatments that typically rely on medication or face-to-face therapy, this program leverages digital technology to deliver mental health support through a series of video sessions. This method not only makes mental health care more accessible by allowing families to participate from home but also emphasizes a family-centered approach, involving both parents and adolescents in the process. By integrating web-conferencing and focusing on family dynamics, this treatment sets itself apart from standard care options and has the potential to engage families in a more holistic and convenient manner.

What evidence suggests that eHealth Familias Unidas is effective for reducing depression and anxiety?

Research has shown that eHealth Familias Unidas, which participants in this trial may receive, can help reduce depression and anxiety in young people. This program uses online tools and family meetings to support mental health care. Previous studies found that similar family-focused programs effectively reduced risky behaviors, suggesting they might also help with mental health issues. This approach is designed to be culturally relevant, potentially making it more effective for Hispanic youth. Early signs indicate that using digital platforms for therapy can lead to better mental health outcomes. ^{1 3 6 7 8}

Who Is on the Research Team?

Guillermo Prado, PhD

Principal Investigator

University of Miami

C. Hendricks Brown, PhD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for Hispanic youths aged 12-16 with symptoms of depression, anxiety, or a history of suicidal behavior. They must live with an adult caregiver who will participate and have internet access at home or elsewhere. Families planning to move out of South Florida during the study cannot join.

Inclusion Criteria

Adolescent living with an adult primary caregiver who is willing to participate

If you or your family have trouble communicating (score less than 75 on a communication test), or if you have a history of feeling very sad, anxious, or have thought about hurting yourself in the past, you may not be able to participate.

I identify as Hispanic or Latino(a).

Exclusion Criteria

Families reporting plans to move out of the South Florida area during the study period.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive eHealth Familias Unidas-Mental Health intervention consisting of nine video parent group sessions, one video adolescent session, and four family sessions over 13 weeks

13 weeks

13 sessions (web-conferencing)

Follow-up

Participants are monitored for changes in mental health symptoms and family functioning

18 months

What Are the Treatments Tested in This Trial?

Interventions

• eHealth Familias Unidas Mental Health

Trial Overview The trial is testing eHealth Familias Unidas Mental Health program's effectiveness in reducing depressive and anxious symptoms and suicide behavior among Hispanic youth in primary care settings across South Florida using a randomized rollout design.

How Is the Trial Designed?

Group I: eHealth Familias Unidas Experimental Treatment 1 Intervention

Participants in this group will receive eHealth Familias Unidas-Mental Health. The intervention consists of nine video parent group sessions, one video adolescent session, and four family sessions (parents participate in a total of 13 sessions, adolescents participate in a total of five sessions) that will be delivered by a facilitator to the parent-child dyad via web-conferencing software across 13 weeks.

Group II: Prevention as Usual Control Active Control 1 Intervention

In this condition, participants will not receive an intervention, only the standard of care services which may include information and referral.

eHealth Familias Unidas Mental Health is already approved in United States for the following indications:

Approved in United States as eHealth Familias Unidas for:

• Depressive symptoms
• Anxious symptoms
• Suicide ideation/behaviors
• Drug use

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

The study will evaluate the effectiveness of an online self-help program (deprexis®) combined with inpatient psychotherapy in 240 depressed patients, aiming to enhance treatment outcomes and maintain benefits after discharge.

Participants will be assessed at multiple points, with the primary focus on changes in depression scores using the Beck Depression Inventory-II, which will help determine if the online program improves overall mental health compared to standard information access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing inpatient psychotherapeutic treatment with online self-help: study protocol for a randomized controlled trial. Zwerenz, R., Becker, J., Knickenberg, RJ., et al.[2022]

The study involving 594 patients showed that implementing computerized outcome feedback (OF) technology in therapy for depression and anxiety did not significantly change clinical outcomes, as measured by PHQ-9 and GAD-7 scores, compared to traditional methods.

However, the use of OF led to a significant reduction in the average duration and cost of treatment, suggesting that OF can enhance the efficiency of stepped care psychological services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the efficiency of psychological treatment using outcome feedback technology. Delgadillo, J., Overend, K., Lucock, M., et al.[2018]

The Fortalezas Familiares (FF) program is a 12-week community-based intervention aimed at supporting Latino families where the mother experiences depression, focusing on improving family relationships and overall well-being.

The program is grounded in family systems theory and developmental psychopathology, highlighting the importance of sociocultural factors in understanding how maternal depression affects children in Latino families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fortalezas familiares program: building sociocultural and family strengths in latina women with depression and their families. Valdez, CR., Abegglen, J., Hauser, CT.[2021]

E-health resources for anxiety and depression in Australia provide valuable information, management interventions, and peer support, which can complement traditional psychological services.

Research shows that online symptom prevention and management programs are effective for adults, and early evaluations for children and adolescents are promising, highlighting the potential of these resources in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anxiety and depression - online resources and management tools. Reynolds, J., Griffiths, K., Christensen, H.[2011]

The study aims to evaluate and improve the effectiveness of internet-based interventions for mental disorders listed in the DiGA-Verzeichnis, which are part of the German healthcare system.

A user-friendly description of these positively evaluated interventions will be made available on psychenet.de, helping users and practitioners access reliable information about mental health treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficiency-Focussed Assessment of Internet-Based Interventions: a Study Protocol]. Köhnen, M., Härter, M., Sander, J., et al.[2022]

The HOLA program is a community health worker-led intervention designed specifically for older Latinos, addressing their unique health beliefs and socioeconomic challenges to prevent depression and anxiety.

This multicomponent health promotion strategy aims to reduce risk factors and improve mental health outcomes, highlighting its potential as an effective and nonstigmatizing approach for this underserved population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

¡HOLA, Amigos! Toward Preventing Anxiety and Depression in Older Latinos. Jimenez, DE., Syed, S., Perdomo-Johnson, D., et al.[2021]

The 'Improvehealth.eu' eHealth service was successfully implemented in a pilot study with 46 patients, showing a significant improvement in medication adherence for those using the intervention (odds ratio = 10.0, P = .03).

Patients using the eHealth service reported feeling more engaged and in control of their treatment, with 81% expressing positive perceptions, suggesting the intervention has potential to enhance treatment outcomes for depressive disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of an eHealth service to support collaborative depression care: results of a pilot study. Meglic, M., Furlan, M., Kuzmanic, M., et al.[2021]

The 'Cuida tu Ánimo' program, aimed at preventing and intervening in adolescent depression, showed moderate to high acceptance among 199 participants from Chile and Colombia, but adherence to the program was lower than expected.

Post-intervention results indicated a reduction in depressive and anxious symptoms among Chilean adolescents, while no significant changes were observed in Colombian adolescents, highlighting the need for customization and context-specific strategies to improve effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of "Cuida tu Ánimo" (Take Care of Your Mood): An Internet-Based Program for Prevention and Early Intervention of Adolescent Depression in Chile and Colombia. Martínez, V., Espinosa-Duque, D., Jiménez-Molina, Á., et al.[2021]

A 6-week study involving 28 English-speaking Latina women showed that a transmedia storytelling intervention significantly reduced symptoms of depression and anxiety, with notable improvements measured at 1 and 6 weeks after engagement.

The intervention also increased participants' confidence in seeking help, with 39% taking action to get help within a week and 82% discussing the media with others, indicating its potential to engage and motivate individuals to address their mental health needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Transmedia Storytelling Intervention With Interactive Elements to Benefit Latinas' Mental Health: Feasibility, Acceptability, and Efficacy. Heilemann, MV., Soderlund, PD., Kehoe, P., et al.[2020]

A psychoeducational group program for depressed patients and their families, conducted over six groups with 101 participants from 1998 to 2000, provided valuable information and skills to improve relationships and understanding of the disorder.

Participants reported high continuity and positive feedback, suggesting that this approach is effective and beneficial, making it a recommended practice for other psychiatric hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychoeducational group for patients with depression and their families]. Harter, C., Kick, J., Rave-Schwank, M.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10112791/

eHealth Familias Unidas Mental Health All data are self-reported. The main outcomes of this study include adolescent depressive symptoms, anxiety symptoms, youth suicide ideation and ...

2. withpower.com withpower.com/trial/phase-drug-use-3-2022-1ec88

eHealth Familias Unidas for Depression and Anxiety Research shows that eHealth services, which use online tools to support mental health care, can improve treatment outcomes for depression and anxiety by ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11587815/

eHealth Familias Unidas Mental Health Familias Unidas is a culturally-syntonic, family-centered intervention effective in reducing youth drug use and sexual risk, with evidence of ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05426057

Study Details | NCT05426057 | Mental Health in Primary ... The goal of this study is to evaluate in an effectiveness-implementation type I hybrid trial, an enhanced version of eHealth Familias Unidas for reducing ...

5. news.miami.edu news.miami.edu/sonhs/stories/2021/08/nih-funds-3-million-latinx-youth-mental-health-trial.html

NIH Funds $3 Million Latinx Youth Mental Health Trial Their trial has three stated aims: First, evaluate the effectiveness of eHealth Familias Unidas for Mental Health in preventing/reducing depressive and anxiety ...

6. academic.oup.com academic.oup.com/tbm/article-abstract/14/12/713/7845233

Adaptation of an evidence-based, preventive intervention to ... This paper describes the systematic process used to adapt the eHealth version of the Familias Unidas intervention to more directly address internalizing ...

7. journals.plos.org journals.plos.org/plosone/article/file?type=supplementary&id=10.1371/journal.pone.0283987.s002

TEMPLATE PROTOCOL AIM 1: Evaluate the effectiveness of eHealth Familias Unidas for Mental Health in preventing/reducing depressive, anxiety symptoms; suicide ideation and ...

8. scholarship.miami.edu scholarship.miami.edu/esploro/outputs/journalArticle/eHealth-Familias-Unidas-Mental-Health-Protocol/991032796305502976

eHealth Familias Unidas Mental Health - Scholarship@Miami This article focuses on the rationale, design and methods of an effectiveness-implementation hybrid type I randomized trial of eHealth Familias Unidas ...