Drug Use Clinical Trial
Official title:
Evaluating the Effectiveness of an eHealth EBI for Latino Youth in Primary Care
Verified date | May 2024 |
Source | University of Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 921 |
Est. completion date | December 18, 2022 |
Est. primary completion date | December 18, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 17 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | PrimeCare Pediatrics | Hialeah | Florida |
United States | Ambulatory Care Center West Pediatrics at Jackson Memorial Hospital | Miami | Florida |
United States | Belkys Bravo Clinic | Miami | Florida |
United States | Borinquean Medical Centers | Miami | Florida |
United States | Borinquen Medical Centers | Miami | Florida |
United States | Castro Pediatrics | Miami | Florida |
United States | Ileana Fuentes Clinic | Miami | Florida |
United States | Kidstown Pediatrics | Miami | Florida |
United States | S. Florida Pediatric Partners | Miami | Florida |
United States | UM Pediatric Mobile Clinic | Miami | Florida |
United States | UM UHealth Pediatrics at the Professional Arts Center | Miami | Florida |
United States | University of Miami UHealth Pediatrics at Kendall | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Miami | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Change in Family Functioning as Assessed by the Parenting Practices Questionnaire | 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. | Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months | |
Secondary | 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.The mean was used to create a sum score. | Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months | |
Secondary | 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.The mean was used to create a sum score. | Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months |
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