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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sexual Risk Behavior, Drug Use, Family Functioning

Intervention / Treatment
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* Behavioral: eHealth Familias Unidas Primary Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eHealth Familias Unidas Primary Care<br>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<br>* 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.<br>* Other names: eHealth Familias Unidas;|
| No Intervention: Treatment as Usual<br>Participants in this condition will not receive an intervention. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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