RecruitingNot Applicable

Mental Health in Primary Care

United States468 participantsStarted 2022-04-26

Plain-language summary

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.

Who can participate

Age range

12 Years – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Female and male adolescents, who self-identify as Hispanic (or Latino(a))
. Adolescent between the ages of 12 - 16 years
. Adolescent living with an adult primary caregiver who is willing to participate
. Families must have broadband internet access on a device, including (but not limited to) a smartphone, iPad, tablet, computer at their home or other location (e.g., school, library, etc.)
. Families screening positive on poor family communication (a score of less than 75 on the communication measure; see measures) or youth reporting elevated depressive or anxiety symptom scores (defined as 70 to 90 on the K-CAT) or a history of suicide behavior (ideation or attempts).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Depression symptoms

Timeframe: Baseline to 3 months, baseline to 6 months, baseline to 18 months

Anxiety symptoms

Timeframe: Baseline to 3 months, baseline to 6 months, baseline to 18 months

Suicidality

Timeframe: Baseline to 3 months, baseline to 6 months, baseline to 18 months

Change in drug use

Timeframe: Baseline to 3 months, baseline to 6 months, baseline to 18 months

Center for Epidemiologic Studies Depression Scale (CESD)

Timeframe: Baseline to 3 months, baseline to 6 months, baseline to 18 months

Trial details

NCT IDNCT05426057

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-30

Contact for this trial

Guillermo Prado, PhD

305-284-2002 gprado@miami.edu

View on ClinicalTrials.gov More Depression, Anxiety trials

Plain-language summary

Who can participate

Age range

12 Years – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Female and male adolescents, who self-identify as Hispanic (or Latino(a))
. Adolescent between the ages of 12 - 16 years
. Adolescent living with an adult primary caregiver who is willing to participate
. Families must have broadband internet access on a device, including (but not limited to) a smartphone, iPad, tablet, computer at their home or other location (e.g., school, library, etc.)
. Families screening positive on poor family communication (a score of less than 75 on the communication measure; see measures) or youth reporting elevated depressive or anxiety symptom scores (defined as 70 to 90 on the K-CAT) or a history of suicide behavior (ideation or attempts).

What they're measuring

Depression symptoms

Timeframe: Baseline to 3 months, baseline to 6 months, baseline to 18 months

Anxiety symptoms

Timeframe: Baseline to 3 months, baseline to 6 months, baseline to 18 months

Suicidality

Timeframe: Baseline to 3 months, baseline to 6 months, baseline to 18 months

Change in drug use

Timeframe: Baseline to 3 months, baseline to 6 months, baseline to 18 months

Center for Epidemiologic Studies Depression Scale (CESD)

Timeframe: Baseline to 3 months, baseline to 6 months, baseline to 18 months