Puerto Rico Cuidalos Parent-adolescent Program

NCT03063385 | Completed Results

• 2 other identifiers: 8202167R01NR013505
• Study Type: interventional
• Target: 660
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Adolescents; Parents; Web-based; Puerto Rico; Latino; Sexual communication; Stigma; Randomized controlled trial; STD; Intercourse; Sexual behavior; HIV/AIDS

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Parental communication intervention

EXPERIMENTAL

The parental experimental intervention consists of a 60-minute web-based intervention consisting of several modules.

Behavioral: Parental Communication intervention

Health promotion control condition.

ACTIVE COMPARATOR

The Health promotion control condition will be web-based and provide useful information for Puerto Rican parents and youth.

Behavioral: Health promotion control condition

Interventions

Parental Communication intervention BEHAVIORAL

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.

Parental communication intervention

Health promotion control condition BEHAVIORAL

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.

Health promotion control condition.

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• one parent and one son or daughter between 13 and 17 years of age must agree to be in the study
• in Puerto Rico

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Nursing Research (NINR): collaborator
• University of Puerto Rico: collaborator
• Yale University: collaborator

Related Publications (1)

• 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.

  PMID: 21116466 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Infections; Sexually Transmitted Diseases; Social Stigma; Coitus; Sexual Behavior

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Results Point of Contact

• Title: Dr. Antonia M. Villarruel
• Organization: University of Pennsylvania School of Nursing

amvillar@nursing.upenn.edu

2158988283

Study Officials

• Antonia M Villarruel, PhD, RN

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Nelson Varas-Diaz, PhD

  University of Puerto Rico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: February 24, 2017
• Study Start: September 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: June 1, 2017
• Last Updated: October 16, 2019
• Results First Posted: October 16, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share