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

Not Applicable

Completed

• Conditions: Sexual Risk Behavior; Drug Use; Family Functioning
• Interventions: Behavioral: eHealth Familias Unidas Primary Care

• Registration Number: NCT03009539
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-11-29
• Study First Submitted QC: 2016-12-30
• Study First Posted: 2017-01-04
• Study Start: 2017-04-18
• Primary Completion: 2022-12-18
• Study Completion: 2022-12-18
• Results First Submitted: 2023-12-18
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-17
• Last Update Submitted: 2024-05-17
• Results First Posted: 2024-06-13
• Last Update Posted: 2024-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 921

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.)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
eHealth Familias Unidas Primary Care	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.

Primary Outcome Measures

Name	Time	Method
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 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.
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 episodes of reported drug use for the previous 90 days with questions from Monitoring the Future
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

Name	Time	Method
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 Scale (Tolan et al., 1997). Subscales include positive parenting (9 items, alpha = .78 for adolescents; alpha = .77 for parents) parental involvement( 20 items, alpha = .86 for adolescents; alpha = .85 parents). Responses range from 0 to 4 with higher values indicating better parenting, higher scores indicate more positive outcomes. The mean for each subscale was used to create a sum score.
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.The mean was used to create a sum score.
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.The mean was used to create a sum score.

Trial Locations

Locations (12)

Ileana Fuentes Clinic; 🇺🇸 Miami, Florida, United States

UM Pediatric Mobile Clinic; 🇺🇸 Miami, Florida, United States

UM UHealth Pediatrics at the Professional Arts Center; 🇺🇸 Miami, Florida, United States

Borinquean Medical Centers; 🇺🇸 Miami, Florida, United States

Borinquen Medical Centers; 🇺🇸 Miami, Florida, United States

Kidstown Pediatrics; 🇺🇸 Miami, Florida, United States

Belkys Bravo Clinic; 🇺🇸 Miami, Florida, United States

University of Miami UHealth Pediatrics at Kendall; 🇺🇸 Miami, Florida, United States

S. Florida Pediatric Partners; 🇺🇸 Miami, Florida, United States

Ambulatory Care Center West Pediatrics at Jackson Memorial Hospital; 🇺🇸 Miami, Florida, United States

Castro Pediatrics; 🇺🇸 Miami, Florida, United States

PrimeCare Pediatrics; 🇺🇸 Hialeah, Florida, United States