Puerto Rico Cuidalos Parent-adolescent Program

Testing a Latino Web-based Parent-adolescent Sexual Communication Intervention

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.

Study Overview

• Status: Completed
• Conditions: Sexually Transmitted Diseases; Pregnancy Prevention; HIV/AIDS and Infections
• Intervention / Treatment: Behavioral: Parental Communication intervention; Behavioral: Health promotion control condition

Detailed Description

In this proposed RCT, and based on recommendations from parents who participated in the initial Cuídalos7 intervention trial, the investigators plan to modify the program by: 1) increasing the amount of content related to sexual communication (e.g., more case studies and interactive activities); 2) adding a module on stigma (towards HIV/AIDS); 3) increasing access by moving from a computer-based to a web-based platform; and 4) increasing the flexibility in how the program is used (e.g., ability to view the entire program or specific modules more than once). In order to examine the efficacy of the program, the investigators will recruit 680 parents and one of the participant's adolescents from schools, community-based and governmental organizations in Puerto Rico, and will randomly assign parents to receive: 1) the Cuídalos intervention; or 2) a web-based health promotion control intervention focused on the prevention of diabetes and cardiovascular disease. Parents and adolescents will complete measures at pre-intervention and at 3- (parents only), 6-, and 12 month follow-ups.

The investigators will address the five following specific aims:

1. Determine whether the Cuídalos intervention increases parents' comfort with, as well as the amount of, general and sexual risk-specific communication with adolescents and whether it decreases stigma (towards HIV/AIDS) at 3-,6-, and 12- month follow-ups as compared to the general health promotion control intervention.
2. Determine whether the Cuídalos intervention decreases self-reported adolescent intercourse and unprotected intercourse at 6-, and 12- month follow-ups as compared to the general health promotion control intervention.
3. Identify theory-based variables (e.g., attitudes, subjective norms, perceived behavioral control, and intentions) that mediate the intervention effects of Cuídalos on parents' self-reported comfort with and amount of communication with their adolescents.
4. Determine whether the effects of the Cuídalos intervention on adolescents sexual behavior and parent adolescent communication are moderated by individual (adolescents: sexual experience, gender, age, stigma; parents: gender, age, computer access and experience, frequency and time engaged in the program), and microsystem (adolescents: parent-adolescent communication) factors.
5. Examine the cost-effectiveness of the web-based Cuídalos intervention on adolescent sexual behavior.

Results from this study will inform the use and efficacy of a web-based Cuídalos program for Puerto Rican parents. This study is an innovative and timely effort given the existing disparities in sexual health outcomes among Latino youth, the lack of culturally and linguistically effective interventions for Latino parents and adolescents, and the absence of web-based interventions with Latinos. If the program is efficacious, the web-based format will accelerate the translation of this program into public health practice and will be an important contribution in supporting adolescent sexual health behaviors.

• Study Type: Interventional
• Enrollment (Actual): 660
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parental communication intervention; The parental experimental intervention consists of a 60-minute web-based intervention consisting of several modules.	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.
Active Comparator: Health promotion control condition.; The Health promotion control condition will be web-based and provide useful information for Puerto Rican parents and youth.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Yale University; National Institute of Nursing Research (NINR); University of Puerto Rico
• Investigators: Principal Investigator: Antonia M Villarruel, PhD, RN, University of Pennsylvania; Principal Investigator: Nelson Varas-Diaz, PhD, University of Puerto Rico

Publications and helpful links

General Publications

• 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. doi: 10.1111/j.1741-3729.2010.00621.x.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: December 14, 2016
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (Actual): February 24, 2017

Study Record Updates

• Last Update Posted (Actual): October 16, 2019
• Last Update Submitted That Met QC Criteria: September 25, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Adolescents; Randomized controlled trial; STD; Parents; Stigma; HIV/AIDS; Puerto Rico; Sexual behavior; Latino; Web-based; Sexual communication; Intercourse
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Sexually Transmitted Diseases
• Other Study ID Numbers: 820216; 7R01NR013505 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO