Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03009539
Other study ID # 20160035
Secondary ID 1R01DA040756
Status Completed
Phase N/A
First received
Last updated
Start date April 18, 2017
Est. completion date December 18, 2022

Study information

Verified date May 2024
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
eHealth Familias Unidas Primary Care
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.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
University of Miami National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT05468879 - Bioequivalence Study of 3 mg Glimepiride Tablet in Indonesia Healthy Subjects N/A
Not yet recruiting NCT06395129 - Low Dead-space Injecting Equipment Distribution Program for People Who Inject Drugs in Low- and Middle-income Countries
Completed NCT02293057 - Gender-Responsive Drug Use Treatment for Juvenile Justice Girls N/A
Completed NCT01941108 - Technology-Enhanced Peer Navigation to Improve IDUs' Engagement in HIV Care N/A
Completed NCT01380613 - Neighborhoods, Networks, Depression, and HIV Risk Phase 2
Withdrawn NCT00914719 - Alcohol Use and Sexual Risk: An Intervention N/A
Recruiting NCT03671629 - Pharmacist Intervention to Reduce Drug-related Readmissions Among the Elderly N/A
Completed NCT03290391 - Linking Infectious and Narcology Care-Part II Phase 4
Completed NCT04008927 - A Community-based Intervention Among Active Drug Users in Montpellier N/A
Completed NCT03627546 - HCV Seek, Test and Rapid Treatment for Young PWID N/A
Not yet recruiting NCT03967262 - Secondary Prevention and Recidivism Reduction in Trauma Patients N/A
Completed NCT03079856 - Drug Use and Sexual Risk Behaviors Among Emerging Adults in the ER N/A
Completed NCT03855410 - Preventing Cigarette Use Among Urban Youth Via an M-Health Primary Care Preventive Intervention N/A
Terminated NCT02457949 - The Impact of Alternative Social Assistance Disbursement on Drug-related Harm N/A
Completed NCT06238154 - Flurbiprofen Tablet vs Spray In Oral Soft Tissue Wounds Phase 4
Terminated NCT04436055 - Intergenerational Effects of Paternal Periconceptional Cannabis and Other Drug Use (EPIC)
Recruiting NCT04717856 - Evaluation of the Use of the GenXpert to Detect Hepatitis C RNA N/A
Completed NCT00249496 - Employment-based Reinforcement to Motivate Drug Abstinence in the Treatment of Drug Addiction. - 1 N/A
Recruiting NCT05597865 - Assessing the Feasibility of Economic Approaches to Prevent Substance Abuse Among Adolescents N/A
Completed NCT05553054 - Drug Wastage : Observational Study in Intensive Care Units in France