Sexually Transmitted Diseases Clinical Trial
Official title:
Testing a Latino Web-based Parent-adolescent Sexual Communication Intervention
Verified date | September 2019 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Latino adolescents are at high risk for HIV/AIDS, other sexually transmitted infections (STIs), and unintended pregnancies. Puerto Rican adolescents, in particular, experience disparities in these areas, yet few adolescent and even fewer parent interventions have been developed to address these important issues with this underserved population. Parent-adolescent programs are an effective approach to reduce adolescent sexual risk behavior and associated negative consequences. A web-based parent communication intervention provides an opportunity to strengthen and enhance programs that are designed for adolescents by providing additional support for safer sex decisions, and to increase parents' access to sexual health education programs by decreasing barriers that keep them from participating in these interventions (e.g., low cost, can be viewed privately, at parents convenience, minimizes competing time with work and family). The purpose of this proposed study is to evaluate a brief theoretically informed (i.e., Ecodevelopmental Theory, Theory of Reasoned Action/Planned Behavior, Social Cognitive Theory 1-6), culturally appropriate, and linguistically tailored web-based parental communication program, Cuídalos ("Take care of them"), designed to improve parent-adolescent sexual communication and reduce adolescent sexual risk behavior. Recent findings from an NIH funded R21 randomized control trial (RCT) testing a brief computer-based version of the Cuídalos program indicated that the program increased parent-adolescent general communication and sexual risk communication with English and Spanish speaking U.S. Latinos. Further, despite limited or no previous computer use, parents reported they liked and learned from the program, and that it was easy to use and accessible.
Status | Completed |
Enrollment | 660 |
Est. completion date | June 2017 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 13 Years to 17 Years |
Eligibility |
Inclusion Criteria: - one parent and one son or daughter between 13 and 17 years of age must agree to be in the study - in Puerto Rico Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania | National Institute of Nursing Research (NINR), University of Puerto Rico, Yale University |
Villarruel AM, Loveland-Cherry CJ, Ronis DL. Testing the Efficacy of a Computer-Based Parent-Adolescent Sexual Communication Intervention for Latino Parents. Fam Relat. 2010 Dec 1;59(5):533-543. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline to 3 Months in Parent - Adolescent Sexual Risk Communication (Parental Perspective) | Computer-based questionnaire reflecting parent-adolescent sexual risk communication. Data presented from the parental perspective. Questionnaire includes 7 items, each measured using a 5-point Likert scale, ranging from 1-5, where a higher score indicates more communication when talking about sexual topics. All primary outcome measures for this study were derived as the mean of the individual items, and was calculated for each participant when 75% or more of the items were completed. When less than 75% of the items were completed, the derived measure was considered incomplete and not included in the measurement. Change was calculated as parent-adolescent sexual risk communication at 3 months minus baseline. | Baseline - 3 months | |
Primary | Change From Baseline to 6 Months in Parent - Adolescent Sexual Risk Communication (Parental Perspective) | Computer-based questionnaire reflecting parent-adolescent sexual risk communication. Data presented from the parental perspective. Questionnaire includes 7 items, each measured using a 5-point Likert scale, ranging from 1-5, where a higher score indicates more communication when talking about sexual topics. All primary outcome measures for this study were derived as the mean of the individual items, and was calculated for each participant when 75% or more of the items were completed. When less than 75% of the items were completed, the derived measure was considered incomplete and not included in the measurement. Change was calculated as parent-adolescent sexual risk communication at 6 months minus baseline. | Baseline - 6 months | |
Primary | Change From Baseline to 12 Months in Parent - Adolescent Sexual Risk Communication (Parental Perspective) | Computer-based questionnaire reflecting parent-adolescent sexual risk communication. Data presented from the parental perspective. Questionnaire includes 7 items, each measured using a 5-point Likert scale, ranging from 1-5, where a higher score indicates more communication when talking about sexual topics. All primary outcome measures for this study were derived as the mean of the individual items, and was calculated for each participant when 75% or more of the items were completed. When less than 75% of the items were completed, the derived measure was considered incomplete and not included in the measurement. Change was calculated as parent-adolescent sexual risk communication at 12 months minus baseline. | Baseline - 12 months |
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