Clinical trial NCT03009539: eHealth Evidence-based Intervention (EBI) for Latino Youth in Primary Care
Official title: Evaluating the Effectiveness of an eHealth EBI for Latino Youth in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-01-04
Enrollment: 921
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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 - 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

Primary outcomes:
measure: Change in Drug Use
timeFrame: Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months
measure: Change in Unprotected Sexual Behavior
timeFrame: Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months
measure: Change in Incidence of Sexually Transmitted Infection
timeFrame: Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months
Secondary outcomes:
measure: Change in Family Functioning as Assessed by the Parenting Practices Questionnaire
timeFrame: Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months
measure: Change in Family Functioning as Assessed by the Parent Relationship With Peer Group
timeFrame: Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months
measure: Change in Family Functioning as Assessed by the Parent-Adolescent Communication Scale
timeFrame: Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months
Other outcomes:
Locations:
city: Hialeah
country: United States
facility: PrimeCare Pediatrics
state: Florida
city: Miami
country: United States
facility: Ileana Fuentes Clinic
state: Florida
city: Miami
country: United States
facility: Ambulatory Care Center West Pediatrics at Jackson Memorial Hospital
state: Florida
city: Miami
country: United States
facility: UM Pediatric Mobile Clinic
state: Florida
city: Miami
country: United States
facility: UM UHealth Pediatrics at the Professional Arts Center
state: Florida
city: Miami
country: United States
facility: Borinquean Medical Centers
state: Florida
city: Miami
country: United States
facility: Borinquen Medical Centers
state: Florida
city: Miami
country: United States
facility: Kidstown Pediatrics
state: Florida
city: Miami
country: United States
facility: Belkys Bravo Clinic
state: Florida
city: Miami
country: United States
facility: Castro Pediatrics
state: Florida
city: Miami
country: United States
facility: University of Miami UHealth Pediatrics at Kendall
state: Florida
city: Miami
country: United States
facility: S. Florida Pediatric Partners
state: Florida
Study officials:
affiliation: University of Miami
name: Guillermo Prado, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: