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 range12 Years – 16 Years

SexALL

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

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 range12 Years – 16 Years

SexALL

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