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

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ClinicalTrials.gov Identifier: NCT03009539
Recruitment Status : Recruiting
First Posted : January 4, 2017
Last Update Posted : December 5, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Guillermo Prado, University of Miami

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sexual Risk Behavior Drug Use Family Functioning Behavioral: eHealth Familias Unidas Primary Care Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 456 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluating the Effectiveness of an eHealth EBI for Latino Youth in Primary Care
Actual Study Start Date : April 26, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.
Other Name: eHealth Familias Unidas

No Intervention: Treatment as Usual
Participants in this condition will not receive an intervention.



Primary Outcome Measures :
  1. Change from baseline in past 90 day drug use as measured at 6, 12, 24 and 36 months post baseline with items from Monitoring the Future Survey [ Time Frame: baseline and 6, 12, 24, and 36 months post baseline ]
  2. Change from baseline in unprotected sexual behavior with the Sexual Behavior Instrument [ Time Frame: baseline and 6, 12, 24, and 36 months post baseline ]
  3. Change from baseline in sexually transmitted infection incidence (i.e., gonorrhea and chlamydia) with a real-time PCR assay using urine specimens collected from adolescent participants [ Time Frame: baseline and 6, 12, 24, and 36 months post baseline ]

Secondary Outcome Measures :
  1. Change from baseline in family functioning utilizing the Parenting Practices Questionnaire [ Time Frame: baseline and 6 months post baseline ]
  2. Change from baseline in family functioning utilizing the Parent-Relation with Peer Group [ Time Frame: baseline and 6 months post baseline ]
  3. Change from baseline in family functioning utilizing the Parent-Adolescent Communication Scale [ Time Frame: baseline and 6 months post baseline ]


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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 - 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03009539


Contacts
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Contact: Guillermo Prado, Ph.D. 305-243-2748 gprado@miami.edu
Contact: Yannine Estrada, Ph.D. 305-243-6614 yestrada@miami.edu

Locations
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United States, Florida
PrimeCare Pediatrics Recruiting
Hialeah, Florida, United States, 33016
Contact: Pilar Delgado, MD         
Ileana Fuentes Clinic Recruiting
Miami, Florida, United States, 33134
Contact: Ileana Fuentes         
Ambulatory Care Center West Pediatrics at Jackson Memorial Hospital Recruiting
Miami, Florida, United States, 33136
Contact: Audrey Ofir, MD         
UM Pediatric Mobile Clinic Recruiting
Miami, Florida, United States, 33136
Contact: Lisa Gwynn, MD         
UM UHealth Pediatrics at the Professional Arts Center Recruiting
Miami, Florida, United States, 33136
Contact: Lourdes Q Forster, MD         
Borinquean Medical Centers Recruiting
Miami, Florida, United States, 33137
Contact: Diego Shmuels         
Borinquen Medical Centers Recruiting
Miami, Florida, United States, 33137
Contact: Diego Shmuels, MD         
Kidstown Pediatrics Suspended
Miami, Florida, United States, 33137
Belkys Bravo Clinic Recruiting
Miami, Florida, United States, 33145
Contact: Belkys Bravo         
Castro Pediatrics Recruiting
Miami, Florida, United States, 33173
Contact: Adriana Castro         
University of Miami UHealth Pediatrics at Kendall Recruiting
Miami, Florida, United States, 33176
Contact: Nicole Torres, MD         
S. Florida Pediatric Partners Recruiting
Miami, Florida, United States, 33196
Contact: Carol Da Costa, MD         
Sponsors and Collaborators
University of Miami
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Guillermo Prado, Ph.D. University of Miami
  Study Documents (Full-Text)

Documents provided by Guillermo Prado, University of Miami:
Informed Consent Form  [PDF] April 23, 2017


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Responsible Party: Guillermo Prado, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03009539     History of Changes
Other Study ID Numbers: 20160035
1R01DA040756 ( U.S. NIH Grant/Contract )
First Posted: January 4, 2017    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Guillermo Prado, University of Miami:
Prevention with Hispanic youth
eHealth preventive intervention in primary care
Hispanic adolescent
Familias Unidas
eHealth Familias Unidas
effectiveness trial
sexually transmitted disease
parent-centered
Hispanic
sexual risk behavior