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

Sponsor
University of Miami (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03009539
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
456
12
2
68.2
38
0.6

Study Details

Study Description

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
  • Behavioral: eHealth Familias Unidas Primary Care
N/A

Study Design

Study Type:
Interventional
Actual 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 :
Apr 26, 2017
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Change in drug use [Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months]

      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

    2. Change in unprotected sexual behavior [Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months]

      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

    3. Change in incidence of sexually transmitted infection [Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months]

      Sexually transmitted infection incidence (i.e., gonorrhea and chlamydia) will be analyzed via a Polymerase Chain Reaction (PCR) from urine specimens

    Secondary Outcome Measures

    1. Change in family functioning as assessed by the Parenting Practices Questionnaire [Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months]

      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.

    2. Change in family functioning as assessed by the Parent Relationship with Peer Group [Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months]

      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.

    3. Change in family functioning as assessed by the Parent-Adolescent Communication Scale [Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 PrimeCare Pediatrics Hialeah Florida United States 33016
    2 Ileana Fuentes Clinic Miami Florida United States 33134
    3 Ambulatory Care Center West Pediatrics at Jackson Memorial Hospital Miami Florida United States 33136
    4 UM Pediatric Mobile Clinic Miami Florida United States 33136
    5 UM UHealth Pediatrics at the Professional Arts Center Miami Florida United States 33136
    6 Borinquean Medical Centers Miami Florida United States 33137
    7 Borinquen Medical Centers Miami Florida United States 33137
    8 Kidstown Pediatrics Miami Florida United States 33137
    9 Belkys Bravo Clinic Miami Florida United States 33145
    10 Castro Pediatrics Miami Florida United States 33173
    11 University of Miami UHealth Pediatrics at Kendall Miami Florida United States 33176
    12 S. Florida Pediatric Partners Miami Florida United States 33196

    Sponsors and Collaborators

    • University of Miami
    • National Institute on Drug Abuse (NIDA)

    Investigators

    • Principal Investigator: Guillermo Prado, Ph.D., University of Miami

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Guillermo Prado, Professor, University of Miami
    ClinicalTrials.gov Identifier:
    NCT03009539
    Other Study ID Numbers:
    • 20160035
    • 1R01DA040756
    First Posted:
    Jan 4, 2017
    Last Update Posted:
    Jun 29, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Guillermo Prado, Professor, University of Miami

    Study Results

    No Results Posted as of Jun 29, 2022