~170 spots leftby Nov 2026

eHealth Familias Unidas for Depression and Anxiety

Recruiting in Palo Alto (17 mi)
+17 other locations
Overseen byGuillermo Prado, PhD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Miami
Disqualifiers: Moving out of South Florida
No Placebo Group
Approved in 2 Jurisdictions

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.

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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.

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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).
+2 more

Exclusion Criteria

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

Trial 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

Participant Groups

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.
2Treatment groups
Experimental Treatment
Active Control
Group I: eHealth Familias UnidasExperimental Treatment1 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 ControlActive Control1 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

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
South Florida Pediatric PartnersMiami, FL
Nicklaus Children HospitalMiami, FL
Medlife Clinical ResearchMiami, FL
UHealth Pediatrics at KendallMiami, FL
More Trial Locations
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Who Is Running the Clinical Trial?

University of MiamiLead Sponsor
National Institute of Mental Health (NIMH)Collaborator

References

Improving the efficiency of psychological treatment using outcome feedback technology. [2018]This study evaluated the impact of applying computerized outcome feedback (OF) technology in a stepped care psychological service offering low and high intensity therapies for depression and anxiety.
Anxiety and depression - online resources and management tools. [2011]There are significant unmet needs for psychological interventions for anxiety and depression in the population. e-health resources complement existing services by providing high quality information, symptom prevention, management interventions and peer support.
[Efficiency-Focussed Assessment of Internet-Based Interventions: a Study Protocol]. [2022]The availability of internet-based interventions for the treatment of mental disorder is steadily growing and is also included in the German health care system. However, there is still room for improvement in terms of the information available to users and practitioners, particularly with regard to the effectiveness of internet-based interventions.
Enhancing inpatient psychotherapeutic treatment with online self-help: study protocol for a randomized controlled trial. [2022]Depression is one of the most debilitating and costly mental disorders. There is increasing evidence for the efficacy of online self-help in alleviating depression. Knowledge regarding the options of combining online self-help with inpatient psychotherapy is still limited. Therefore, we plan to evaluate an evidence-based self-help program (deprexis®; Gaia AG, Hamburg, Germany) to improve the efficacy of inpatient psychotherapy and to maintain treatment effects in the aftercare period.
Feasibility of an eHealth service to support collaborative depression care: results of a pilot study. [2021]Treatments and organizational changes supported by eHealth are beginning to play an important role in improving disease treatment outcome and providing cost-efficient care management. "Improvehealth.eu" is a novel eHealth service to support the treatment of patients with depressive disorder. It offers active patient engagement and collaborative care management by combining Web- and mobile-based information and communication technology systems and access to care managers.
¡HOLA, Amigos! Toward Preventing Anxiety and Depression in Older Latinos. [2021]Given the prevalence and morbidity of depression and anxiety in later life, the inadequacies of current treatment approaches for averting years living with disability, the disparities in access to the mental healthcare delivery system, and the workforce shortages to meet the mental health needs of older Latinos, development and testing of innovative strategies to prevent depression and anxiety are of great public health significance and have the potential to change practice. Although impediments to good depression and anxiety outcomes exist for all older adults, they are even more pronounced for older Latinos, who tend to have fewer socioeconomic resources. These factors underscore the need for prevention-based interventions that are effective, scalable, relevant, respectful, and specific to this population. The Happy Older Latinos are Active (HOLA) program is a community health worker-led, multicomponent, health promotion intervention. The diverse needs and circumstances of older Latinos (highly sedentary, culture-specific health beliefs, service disparities) were incorporated into the design of HOLA to reduce risk factors and improve health-related outcomes associated with common mental disorders in this group. The authors describe HOLA (highlighted in this case example) and why health promotion interventions like HOLA may hold promise as effective, practical, and nonstigmatizing interventions for preventing common mental disorders in older Latinos who are at risk for developing these disorders.
A Transmedia Storytelling Intervention With Interactive Elements to Benefit Latinas' Mental Health: Feasibility, Acceptability, and Efficacy. [2020]Latinos report higher rates of depression and anxiety than US whites but are less likely to receive care. Transmedia storytelling interventions accessible on the Internet via smartphones, tablets, and computers hold promise for reducing reluctance to explore or get help for symptoms because they are private, convenient, and can reach large numbers of people, including Latinas with mental health needs.
Fortalezas familiares program: building sociocultural and family strengths in latina women with depression and their families. [2021]The purpose of this article is to describe Fortalezas Familiares (FF; Family Strengths), a community-based prevention program designed to address relational family processes and promote well-being among Latino families when a mother has depression. Although depression in Latina women is becoming increasingly recognized, risk and protective mechanisms associated with children's outcomes when a mother has depression are not well understood for Latino families. We begin by reviewing the literature on risk and protective psychosocial mechanisms by which maternal depression may affect Latino youth, using family systems theory and a developmental psychopathology framework with an emphasis on sociocultural factors shaping family processes. Next, we describe the theoretical basis and development of the FF program, a community-based 12-week intervention for Latina immigrant women with depression, other caregivers, and their children. Throughout this article, we use a case study to illustrate a Latina mother's vulnerability to depression and the family's response to the FF program. Recommendations for future research and practice include consideration of sociocultural processes in shaping both outcomes of Latino families and their response to interventions.
[Psychoeducational group for patients with depression and their families]. [2019]Psychoeducation is an important part in the therapy of mental diseases. Until now there is little experience with patients and their family members attending the same psychoeducational group. We work with a psychoeducational group for depressed patients and their families. The aims are support and relief for the family, information about the affective disorder and acquisition of skills to improve the relationship between patients and family members. Every three months we start a new group with three sessions. At the first session we give information about symptoms, the disease and prognosis. At the second meeting we discuss the causes and how to deal with the disorder. The contents of the last session are the treatment and recidive prophylaxis. In the time from winter 1998 to spring 2000 six different groups have taken place with 101 patients and family members as participants. There was a high continuity of participation and a positive feed-back of the members. We can recommend this kind of psychoeducational group for other psychiatric hospitals. Patients and their family members can come to terms with this illness and become experts on depression.
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]The rapid internet penetration in Latin American countries has made it possible to implement digital mental health interventions. "Cuida tu &#193;nimo" (Take Care of Your Mood) is an internet-based program for the prevention and early intervention of depression in adolescents. A pilot study was conducted in Chile and Colombia to study the feasibility and acceptability of the program and estimate its effects. There were 199 participants (53.3% women; mean age = 14.8 years, SD = 1.0) recruited from two schools in Chile and two schools in Colombia. Qualitative and quantitative methods were applied for data collection and analyses. Although the levels of acceptance were moderate to high across all variables, adherence was lower than expected. The participants deemed important for an intervention of this type offered a higher level of interaction with team members through internet-based and face-to-face activities. Post-intervention outcomes show a reduction in depressive and anxious symptoms in adolescents in Chile, while there were no significant changes in the level of symptomatology in adolescents in Colombia. The women used the program more than the men. Results show the need to improve the intervention by increasing its levels of customization and developing strategies to achieve better adherence. The contradictory results of the program in Chile and Colombia suggest the importance of other variables beyond the content of the intervention, such as the setting or context of the intervention.