eHealth Familias Unidas for Depression and Anxiety

Recruiting at 17 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

Trial Summary

What is the purpose of this trial?

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 depressive, anxious symptoms and suicide behavior in Hispanic youth. The study will use a randomized rollout design with 18 pediatric primary care clinics in the South Florida area.

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 data supports the effectiveness of the treatment 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 providing information, symptom management, and peer support. ^{1 2 3 4 5}

What makes the eHealth Familias Unidas treatment unique for depression and anxiety?

The eHealth Familias Unidas treatment is unique because it uses a digital platform to deliver culturally tailored mental health support to Latino families, making it accessible and convenient for those who may face barriers to traditional mental health care. This approach leverages technology to reach a wider audience and addresses specific cultural needs, which can be particularly beneficial for Latino communities who experience higher rates of depression and anxiety but often have less access to care. ^{6 7 8 9 10}

Research Team

Guillermo Prado, PhD

Principal Investigator

University of Miami

C. Hendricks Brown, PhD

Principal Investigator

Northwestern University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 '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 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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Improving the efficiency of psychological treatment using outcome feedback technology. [2018]

2. Australia pubmed.ncbi.nlm.nih.gov

Anxiety and depression - online resources and management tools. [2011]

3. Germany pubmed.ncbi.nlm.nih.gov

[Efficiency-Focussed Assessment of Internet-Based Interventions: a Study Protocol]. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Enhancing inpatient psychotherapeutic treatment with online self-help: study protocol for a randomized controlled trial. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

Feasibility of an eHealth service to support collaborative depression care: results of a pilot study. [2021]

6. England pubmed.ncbi.nlm.nih.gov

¡HOLA, Amigos! Toward Preventing Anxiety and Depression in Older Latinos. [2021]

7. Canada pubmed.ncbi.nlm.nih.gov

A Transmedia Storytelling Intervention With Interactive Elements to Benefit Latinas' Mental Health: Feasibility, Acceptability, and Efficacy. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Fortalezas familiares program: building sociocultural and family strengths in latina women with depression and their families. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

[Psychoeducational group for patients with depression and their families]. [2019]

10. Switzerland 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. [2021]