Puerto Rico Cuidalos Parent-adolescent Program

NCT03063385 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 660

Last updated 2019-10-16

Study results available
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Summary

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.

Conditions

  • HIV/AIDS and Infections
  • Sexually Transmitted Diseases
  • Pregnancy Prevention

Interventions

BEHAVIORAL

Parental Communication intervention

In this intervention, we focus on providing parents with basic knowledge about pregnancy, HIV/AIDS, and STDs as a basis for effectively communicating with their adolescents. We work to support attitudes and develop skills to facilitate communication in general and specifically sexual communication. Based on our prior work we focus on prevention beliefs, reaction beliefs, and communication efficacy. Importantly, we include a component on HIV/AIDS stigma as we conceptualize this to impact attitudes and communication about sex. We will program the intervention in such a way so that parents will have to view the Cuídalos program sequentially and in its totality before being able to review any content.

BEHAVIORAL

Health promotion control condition

In this intervention, we provide a web-based program relying on existing Spanish language web-sites to provide participants with helpful information to prevent significant health problems affecting Puerto Rican adolescents that are related, not to sexual behavior, but to other behaviors. Similar to the experimental condition, we will develop a set of "homework" related to diet and exercise that we will ask parents to complete with their adolescents.

Sponsors & Collaborators

  • National Institute of Nursing Research (NINR)

    collaborator NIH
  • University of Puerto Rico

    collaborator OTHER
  • Yale University

    collaborator OTHER
  • University of Pennsylvania

    lead OTHER

Principal Investigators

  • Antonia M Villarruel, PhD, RN · University of Pennsylvania

  • Nelson Varas-Diaz, PhD · University of Puerto Rico

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2016-08-31
Completion
2017-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03063385 on ClinicalTrials.gov