- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01084421
A Computer-Based Parent/Adolescent HIV Communication Intervention for Latinos
August 29, 2016 updated by: Antonia M. Villarruel, University of Michigan
The purpose of this study is to examine the efficacy of a brief culturally appropriate and theory-based parental communication intervention designed to improve parent-adolescent sexual communication and reduce adolescent sexual risk behavior.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Latino adolescents are at high risk for contracting HIV/AIDS.
Few individual and even fewer parent interventions have been developed to address this persistent problem.
Parent communication interventions provide an opportunity to enhance individual adolescent based approaches.
However, there is a need for theory and culture based interventions focused on Latino parents.
The program implemented in this study was designed for parents, to indirectly help reduce the health risks of their adolescents, including unintended pregnancy and STDs, including HIV/AIDS.
The study has three aims regarding the examination of whether the computer based parental communication intervention is 1) associated with a greater increase in parents' comfort with, and quantity of communication; 2) associated with a greater increase in adolescents' intentions to abstain from sex and/or avoid unprotected intercourse and decreased self-reported intercourse and unprotected intercourse; and 3) feasible and acceptable to Spanish dominant Latino parents and their adolescent children.
Study Type
Interventional
Enrollment (Actual)
260
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48216
- Detroit Hispanic Development Corporation (DHDC)
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Latino parents who have adolescents 14 to 17 years of age
- Spanish dominant or bilingual
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Computer based intervention
Participants receive content about adolescent sexual risk and HIV prevention, strategies to support sexual specific communication and parent-adolescent communication in general.
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The parental intervention consists of a 60 minute computer-based program delivered in two sessions (one per week).
The DVD ROM provides information about adolescent sexual risk and HIV prevention, strategies to support sexual specific communication and parent-adolescent communication in general.
The computer based education program is provided in Spanish.
Other Names:
|
No Intervention: Wait list control group
Participants will receive the computer based intervention at 3 months follow-up
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
general parent-adolescent communication, parent-adolescent sexual risk communication, comfort with communication
Time Frame: pretest, 1 week, 3 months
|
pretest, 1 week, 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Antonia M Villarruel, PhD,RN,FAAN, University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
March 9, 2010
First Submitted That Met QC Criteria
March 9, 2010
First Posted (Estimate)
March 10, 2010
Study Record Updates
Last Update Posted (Estimate)
August 31, 2016
Last Update Submitted That Met QC Criteria
August 29, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- HUM00020148
- R21NR010457 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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