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OpenTrials
Completed

NCT Number: NCT03009539

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

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.

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Key information

Conditions

Sexual Risk Behavior Communicable Diseases Disease Attributes Drug Use Family Functioning Genital Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Urogenital Diseases

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PrimeCare Pediatrics, Hialeah, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eHealth Familias Unidas Primary Care

Behavioral

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.

Other names: eHealth Familias Unidas

Primary outcomes

  1. Change in Drug Use

    Time frame: 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

  2. Change in Unprotected Sexual Behavior

    Time frame: 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.

  3. Change in Incidence of Sexually Transmitted Infection

    Time frame: 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 outcomes

  1. Change in Family Functioning as Assessed by the Parenting Practices Questionnaire

    Time frame: 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.

  2. Change in Family Functioning as Assessed by the Parent Relationship With Peer Group

    Time frame: 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.

  3. Change in Family Functioning as Assessed by the Parent-Adolescent Communication Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jan 4, 2017
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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