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

Evaluating the Effectiveness of an eHealth EBI for Latino Youth in Primary Care

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.

Study Overview

• Status: Completed
• Conditions: Drug Use; Sexual Risk Behavior; Family Functioning
• Intervention / Treatment: Behavioral: eHealth Familias Unidas Primary Care

• Study Type: Interventional
• Enrollment (Actual): 456
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Hialeah, Florida, United States, 33016
      • PrimeCare Pediatrics
    • Miami, Florida, United States, 33134
      • Ileana Fuentes Clinic
    • Miami, Florida, United States, 33136
      • Ambulatory Care Center West Pediatrics at Jackson Memorial Hospital
    • Miami, Florida, United States, 33136
      • UM Pediatric Mobile Clinic
    • Miami, Florida, United States, 33136
      • UM UHealth Pediatrics at the Professional Arts Center
    • Miami, Florida, United States, 33137
      • Borinquean Medical Centers
    • Miami, Florida, United States, 33137
      • Borinquen Medical Centers
    • Miami, Florida, United States, 33137
      • Kidstown Pediatrics
    • Miami, Florida, United States, 33145
      • Belkys Bravo Clinic
    • Miami, Florida, United States, 33173
      • Castro Pediatrics
    • Miami, Florida, United States, 33176
      • University of Miami UHealth Pediatrics at Kendall
    • Miami, Florida, United States, 33196
      • S. Florida Pediatric Partners

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: eHealth Familias Unidas
No Intervention: Treatment as Usual; Participants in this condition will not receive an intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in drug use	Change in drug use will be reported as the number of days of reported drug use for the previous 90 days with questions from Monitoring the Future	Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months
Change in unprotected sexual behavior	Change in unprotected sexual behavior will be reported as endorsement of having had sex without a condom during the previous 90 days using the Sexual Behavior Instrument	Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months
Change in incidence of sexually transmitted infection	Sexually transmitted infection incidence (i.e., gonorrhea and chlamydia) will be analyzed via a Polymerase Chain Reaction (PCR) from urine specimens	Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in family functioning as assessed by the Parenting Practices Questionnaire	Change in family functioning will be reported using the Parenting Practices Questionnaire . Response range varies based on questions, but most response items range from 0 to 4 with higher values indicating better parenting.	Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months
Change in family functioning as assessed by the Parent Relationship with Peer Group	Change in family functioning will be reported using the Parent Relationship with Peer Group. The Parent Relationship with Peer Group is a six item measure with response items ranging from 0 to 24. Higher scores indicate better outcomes.	Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months
Change in family functioning as assessed by the Parent-Adolescent Communication Scale	Change in family functioning will be reported using the Parent-Adolescent Communication Scale. The Parent-Adolescent Communication Scale is a twenty-item questionnaire with a total score ranging from 20 to 100 with higher scores indicating better communication.	Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Guillermo Prado, Ph.D., University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2017
• Primary Completion (Actual): December 18, 2022
• Study Completion (Actual): December 18, 2022

Study Registration Dates

• First Submitted: November 29, 2016
• First Submitted That Met QC Criteria: December 30, 2016
• First Posted (Estimate): January 4, 2017

Study Record Updates

• Last Update Posted (Estimate): January 9, 2023
• Last Update Submitted That Met QC Criteria: January 5, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: 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
• Other Study ID Numbers: 20160035; 1R01DA040756 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No