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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01084421
Other study ID # HUM00020148
Secondary ID R21NR010457
Status Completed
Phase N/A
First received March 9, 2010
Last updated August 29, 2016
Start date September 2007
Est. completion date June 2010

Study information

Verified date August 2016
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 260
Est. completion date June 2010
Est. primary completion date September 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Latino parents who have adolescents 14 to 17 years of age

- Spanish dominant or bilingual

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Computer-based parent-adolescent HIV communication
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.

Locations

Country Name City State
United States Detroit Hispanic Development Corporation (DHDC) Detroit Michigan

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary general parent-adolescent communication, parent-adolescent sexual risk communication, comfort with communication pretest, 1 week, 3 months No
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