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Behavioral Intervention

eHealth Familias Unidas for Depression and Anxiety

N/A

Recruiting

Led By Guillermo Prado, PhD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adolescent between the ages of 12 - 16 years

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 3 months, baseline to 6 months, baseline to 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate an enhanced version of eHealth Familias Unidas, which is designed to help reduce depressive and anxious symptoms, as well as suicide behavior, in Hispanic youth. The study will be conducted in 18 pediatric primary care clinics in South Florida.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves an eHealth program rather than medication, traditional physical side effects are not expected; however, participants may experience emotional discomfort when discussing mental health issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 12 and 16 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 3 months, baseline to 6 months, baseline to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 3 months, baseline to 6 months, baseline to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 3 months, baseline to 6 months, baseline to 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Anxiety symptoms

Center for Epidemiologic Studies Depression Scale (CESD)

Change in drug use

+2 more

Secondary study objectives

Change in Family Functioning as assessed by the Parent Relationship with Peer Group

Change in Family Functioning as assessed by the Parent-Adolescent Communication Scale

Change in Family Functioning as assessed by the Parenting Practices Questionnaire

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 1Eligibility criteria met