eHealth Evidence-based Intervention (EBI) for Latino Youth in Primary Care

NCT ID: NCT03009539

Last Updated: 2024-06-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

921 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-18

Study Completion Date

2022-12-18

Brief Summary

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The purpose of this study is to test the relative effectiveness of a Hispanic-specific eHealth intervention, "e-Health Familias Unidas," in preventing and reducing drug use, sexual risk behaviors, and STIs among Hispanic youth in primary care. Families will be recruited through four pediatric primary care settings. Pediatric staff and research team members, including nurse assistants and mental health professionals, will implement eHealth Familias Unidas.

Detailed Description

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Conditions

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Sexual Risk Behavior Drug Use Family Functioning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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eHealth Familias Unidas Primary Care

eHealth Familias Unidas consists of 12 sessions: eight (12 - 15 minute) "mock" parent sessions in Spanish and four (30 - 45 minute) online family sessions delivered in either Spanish and/or English.

Group Type EXPERIMENTAL

eHealth Familias Unidas Primary Care

Intervention Type BEHAVIORAL

The experimental condition will consist of "eHealth Familias Unidas Primary Care." eHealth Familias Unidas Primary Care is an adaptation of the face-to-face version of Familias Unidas. As with face-to-face Familias Unidas, eHealth Familias Unidas Primary Care aims to prevent drug use, sexual risk behaviors, and STIs by improving family functioning. Similar to face-to-face Familias Unidas, eHealth Familias Unidas is a multi-level intervention that targets risk and protective factors at the multiple systems affecting the youth and youths' family.

Treatment as Usual

Participants in this condition will not receive an intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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eHealth Familias Unidas Primary Care

The experimental condition will consist of "eHealth Familias Unidas Primary Care." eHealth Familias Unidas Primary Care is an adaptation of the face-to-face version of Familias Unidas. As with face-to-face Familias Unidas, eHealth Familias Unidas Primary Care aims to prevent drug use, sexual risk behaviors, and STIs by improving family functioning. Similar to face-to-face Familias Unidas, eHealth Familias Unidas is a multi-level intervention that targets risk and protective factors at the multiple systems affecting the youth and youths' family.

Intervention Type BEHAVIORAL

Other Intervention Names

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eHealth Familias Unidas

Eligibility Criteria

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Inclusion Criteria

* Female and male adolescents of Hispanic immigrant origin, defined by at least one parent born in a Spanish speaking country of the Americas. Parent must understand Spanish given that parent sessions are delivered in Spanish.
* Adolescent between the ages of 12 - 17 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 smart phone, iPad, tablet, a home computer or a computer at another location (e.g., school, library, etc.)

Exclusion Criteria

* Families reporting plans to move out of the South Florida area during the study period
* Families reporting that adolescent has been diagnosed with a developmental delay
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Guillermo Prado

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guillermo Prado, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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PrimeCare Pediatrics

Hialeah, Florida, United States

Site Status

Ileana Fuentes Clinic

Miami, Florida, United States

Site Status

Ambulatory Care Center West Pediatrics at Jackson Memorial Hospital

Miami, Florida, United States

Site Status

UM Pediatric Mobile Clinic

Miami, Florida, United States

Site Status

UM UHealth Pediatrics at the Professional Arts Center

Miami, Florida, United States

Site Status

Borinquean Medical Centers

Miami, Florida, United States

Site Status

Borinquen Medical Centers

Miami, Florida, United States

Site Status

Kidstown Pediatrics

Miami, Florida, United States

Site Status

Belkys Bravo Clinic

Miami, Florida, United States

Site Status

Castro Pediatrics

Miami, Florida, United States

Site Status

University of Miami UHealth Pediatrics at Kendall

Miami, Florida, United States

Site Status

S. Florida Pediatric Partners

Miami, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1R01DA040756

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20160035

Identifier Type: -

Identifier Source: org_study_id

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