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

NCT03009539 | Completed Results DMC

• 2 other identifiers: 201600351R01DA040756
• Study Type: interventional
• Target: 921
• Locations: 1 country
• Sites: 12

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.

Conditions

Sexual Risk Behavior; Drug Use; Family Functioning

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

Outcome Measures

Primary Outcomes (3)

• Change in Drug Use

  Change in drug use will be reported as the episodes 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 was reported as endorsement incidence of having had sex without a condom during the previous 90 days using the Sexual Behavior Instrument. Higher values indicate worst outcomes.

  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 Outcomes (3)

• 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 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 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

Study Arms (2)

eHealth Familias Unidas Primary Care

EXPERIMENTAL

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

Treatment as Usual

NO INTERVENTION

Participants in this condition will not receive an intervention.

Interventions

eHealth Familias Unidas Primary Care 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.

Also known as: eHealth Familias Unidas

eHealth Familias Unidas Primary Care

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (12)

PrimeCare Pediatrics

Hialeah, Florida, 33016, United States

Location

Ileana Fuentes Clinic

Miami, Florida, 33134, United States

Location

Ambulatory Care Center West Pediatrics at Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

UM Pediatric Mobile Clinic

Miami, Florida, 33136, United States

Location

UM UHealth Pediatrics at the Professional Arts Center

Miami, Florida, 33136, United States

Location

Borinquean Medical Centers

Miami, Florida, 33137, United States

Location

Borinquen Medical Centers

Miami, Florida, 33137, United States

Location

Kidstown Pediatrics

Miami, Florida, 33137, United States

Location

Belkys Bravo Clinic

Miami, Florida, 33145, United States

Location

Castro Pediatrics

Miami, Florida, 33173, United States

Location

University of Miami UHealth Pediatrics at Kendall

Miami, Florida, 33176, United States

Location

S. Florida Pediatric Partners

Miami, Florida, 33196, United States

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Guillermo Prado
• Organization: University of Miami

gprado@miami.edu

305-284-2002

Study Officials

• Guillermo Prado, Ph.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: January 4, 2017
• Study Start: April 18, 2017
• Primary Completion: December 18, 2022
• Study Completion: December 18, 2022
• Last Updated: June 13, 2024
• Results First Posted: June 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)