Mental Health in Primary Care

University of Miami

Status: Enrolling

Conditions: Depression, Anxiety; Drug Use; Suicide

Treatments: Behavioral: eHealth Familias Unidas Mental Health

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05426057

20210286

1R01MH124718-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 468 estimated patients

Sex: All

Ages: 12 to 16 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Female and male adolescents, who self-identify as Hispanic (or Latino(a))
2. Adolescent between the ages of 12 - 16 years
3. Adolescent living with an adult primary caregiver who is willing to participate
4. 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.)
5. 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).

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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468 participants in 2 patient groups

eHealth Familias Unidas

Experimental group

Description:

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.

Treatment:

Behavioral: eHealth Familias Unidas Mental Health

Prevention as Usual Control

No Intervention group

Description:

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