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

Drug Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03009539
• Other study ID #: 20160035
• Secondary ID: 1R01DA040756
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Drug Use
• Family Functioning
• Sexual Risk Behavior

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