HIV/AIDS and Infections, Pregnancy Prevention, Sexually Transmitted Diseases
Conditions
Keywords
Adolescents, Parents, Web-based, Puerto Rico, Latino, Sexual communication, Stigma, Randomized controlled trial, STD, Intercourse, Sexual behavior, HIV/AIDS
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.
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.
Interventions
BEHAVIORALParental 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.
BEHAVIORALHealth 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
National Institute of Nursing Research (NINR)
University of Puerto Rico
Yale University
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to 3 Months in Parent - Adolescent Sexual Risk Communication (Parental Perspective) | Baseline - 3 months | 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. |
| Change From Baseline to 6 Months in Parent - Adolescent Sexual Risk Communication (Parental Perspective) | Baseline - 6 months | 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. |
| Change From Baseline to 12 Months in Parent - Adolescent Sexual Risk Communication (Parental Perspective) | Baseline - 12 months | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Parental Communication Intervention The parental experimental intervention consists of a 60-minute web-based intervention consisting of several modules.
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. | 330 |
| Health Promotion Control Condition. The Health promotion control condition will be web-based and provide useful information for Puerto Rican parents and youth.
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. | 330 |
| Total | 660 |
Baseline characteristics
| Characteristic | Parental Communication Intervention | Health Promotion Control Condition. | Total |
|---|---|---|---|
| Age, Continuous Adolescents | 14.52 Years STANDARD_DEVIATION 1.26 | 14.57 Years STANDARD_DEVIATION 1.33 | 14.55 Years STANDARD_DEVIATION 1.29 |
| Age, Continuous Adults | 42.41 Years STANDARD_DEVIATION 8.17 | 42.62 Years STANDARD_DEVIATION 8.34 | 42.52 Years STANDARD_DEVIATION 8.25 |
| Average Monthly Income ≥$1700 | 36 Participants | 18 Participants | 54 Participants |
| Average Monthly Income <$300 | 22 Participants | 29 Participants | 51 Participants |
| Average Monthly Income $300-$799 | 22 Participants | 24 Participants | 46 Participants |
| Average Monthly Income $800-$1699 | 24 Participants | 40 Participants | 64 Participants |
| Average Monthly Income Unknown | 226 Participants | 219 Participants | 445 Participants |
| Child's Sex Female | 174 Participants | 168 Participants | 342 Participants |
| Child's Sex Male | 154 Participants | 162 Participants | 316 Participants |
| Child's Sex Missing | 2 Participants | 0 Participants | 2 Participants |
| Comfort with Communication between parent and adolescent | 3.50 Units on a scale STANDARD_DEVIATION 0.61 | 3.51 Units on a scale STANDARD_DEVIATION 0.6 | 3.5 Units on a scale STANDARD_DEVIATION 0.6 |
| Education Completed college | 151 Participants | 141 Participants | 292 Participants |
| Education Completed high school | 95 Participants | 95 Participants | 190 Participants |
| Education Did not complete college | 50 Participants | 52 Participants | 102 Participants |
| Education Did not complete high school | 32 Participants | 40 Participants | 72 Participants |
| Education Missing | 2 Participants | 2 Participants | 4 Participants |
| Employment Outside of Home Missing | 2 Participants | 0 Participants | 2 Participants |
| Employment Outside of Home No | 200 Participants | 201 Participants | 401 Participants |
| Employment Outside of Home Yes | 128 Participants | 129 Participants | 257 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 179 Participants | 184 Participants | 363 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 5 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 145 Participants | 141 Participants | 286 Participants |
| General Communication between parent and adolescent | 3.84 Units on a scale STANDARD_DEVIATION 0.62 | 3.88 Units on a scale STANDARD_DEVIATION 0.59 | 3.86 Units on a scale STANDARD_DEVIATION 0.6 |
| Government Assistance Missing | 2 Participants | 0 Participants | 2 Participants |
| Government Assistance No | 118 Participants | 128 Participants | 246 Participants |
| Government Assistance Yes | 210 Participants | 202 Participants | 412 Participants |
| Marital Status Divorced | 51 Participants | 42 Participants | 93 Participants |
| Marital Status Live in Partner | 38 Participants | 34 Participants | 72 Participants |
| Marital Status Married | 127 Participants | 142 Participants | 269 Participants |
| Marital Status Missing | 2 Participants | 0 Participants | 2 Participants |
| Marital Status Separated | 9 Participants | 13 Participants | 22 Participants |
| Marital Status Single | 98 Participants | 89 Participants | 187 Participants |
| Marital Status Widowed | 5 Participants | 10 Participants | 15 Participants |
| Monthly Government Assistance Income | 568.78 Currency, US dollars STANDARD_DEVIATION 854.96 | 537.16 Currency, US dollars STANDARD_DEVIATION 650.46 | 553.32 Currency, US dollars STANDARD_DEVIATION 761.09 |
| Number of Children in House | 1.53 Child STANDARD_DEVIATION 0.76 | 1.56 Child STANDARD_DEVIATION 0.72 | 1.54 Child STANDARD_DEVIATION 0.74 |
| Number of Work Hours per week | 33.41 Hours STANDARD_DEVIATION 13.35 | 31.62 Hours STANDARD_DEVIATION 13.35 | 32.50 Hours STANDARD_DEVIATION 13.35 |
| Parents' Computer Comfort Missing | 2 Participants | 2 Participants | 4 Participants |
| Parents' Computer Comfort Somewhat comfortable | 78 Participants | 73 Participants | 151 Participants |
| Parents' Computer Comfort Somewhat uncomfortable | 20 Participants | 15 Participants | 35 Participants |
| Parents' Computer Comfort Very comfortable | 226 Participants | 233 Participants | 459 Participants |
| Parents' Computer Comfort Very uncomfortable | 4 Participants | 7 Participants | 11 Participants |
| Parents' Ease/Difficulty Finding a Computer Difficult | 52 Participants | 57 Participants | 109 Participants |
| Parents' Ease/Difficulty Finding a Computer Easy | 115 Participants | 125 Participants | 240 Participants |
| Parents' Ease/Difficulty Finding a Computer Missing | 3 Participants | 2 Participants | 5 Participants |
| Parents' Ease/Difficulty Finding a Computer Very difficult | 20 Participants | 15 Participants | 35 Participants |
| Parents' Ease/Difficulty Finding a Computer Very easy | 140 Participants | 131 Participants | 271 Participants |
| Partner Missing | 3 Participants | 0 Participants | 3 Participants |
| Partner No | 129 Participants | 116 Participants | 245 Participants |
| Partner Yes | 198 Participants | 214 Participants | 412 Participants |
| Program Location Community Agency | 62 Participants | 58 Participants | 120 Participants |
| Program Location Home | 46 Participants | 58 Participants | 104 Participants |
| Program Location Missing | 4 Participants | 3 Participants | 7 Participants |
| Program Location Other Location | 46 Participants | 46 Participants | 92 Participants |
| Program Location School | 172 Participants | 165 Participants | 337 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 9 Participants | 7 Participants | 16 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 35 Participants | 42 Participants | 77 Participants |
| Race (NIH/OMB) More than one race | 24 Participants | 24 Participants | 48 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 170 Participants | 170 Participants | 340 Participants |
| Race (NIH/OMB) White | 89 Participants | 85 Participants | 174 Participants |
| Region of Enrollment Puerto Rico | 330 Participants | 330 Participants | 660 Participants |
| Self-Efficacy by adolescents | 3.77 Units on a scale STANDARD_DEVIATION 0.9 | 3.89 Units on a scale STANDARD_DEVIATION 0.91 | 3.83 Units on a scale STANDARD_DEVIATION 0.91 |
| Sex/Gender, Customized Female | 296 Participants | 295 Participants | 591 Participants |
| Sex/Gender, Customized Male | 32 Participants | 35 Participants | 67 Participants |
| Sex/Gender, Customized Missing | 2 Participants | 0 Participants | 2 Participants |
| Sexual Communication Attitudes by adolescents | 3.71 Units on a scale STANDARD_DEVIATION 0.51 | 3.77 Units on a scale STANDARD_DEVIATION 0.46 | 3.74 Units on a scale STANDARD_DEVIATION 0.49 |
| Sexual Communication Intentions by adolescents | 4.02 Units on a scale STANDARD_DEVIATION 0.94 | 4.00 Units on a scale STANDARD_DEVIATION 0.96 | 4.01 Units on a scale STANDARD_DEVIATION 0.95 |
| Sexual Peer Pressure between parent and adolescent | 3.52 Units on a scale STANDARD_DEVIATION 1.21 | 3.71 Units on a scale STANDARD_DEVIATION 1.29 | 3.62 Units on a scale STANDARD_DEVIATION 1.25 |
| Sexual Prevention Communication between parent and adolescent | 3.07 Units on a scale STANDARD_DEVIATION 1.31 | 3.25 Units on a scale STANDARD_DEVIATION 1.35 | 3.16 Units on a scale STANDARD_DEVIATION 1.33 |
| Sexual Protection Communication between parents and adolescents | 2.74 Units on a scale STANDARD_DEVIATION 1.36 | 2.93 Units on a scale STANDARD_DEVIATION 1.36 | 2.83 Units on a scale STANDARD_DEVIATION 1.36 |
| Sexual Risk Communication between parent and adolescent | 3.12 Units on a scale STANDARD_DEVIATION 1.12 | 3.31 Units on a scale STANDARD_DEVIATION 1.16 | 3.22 Units on a scale STANDARD_DEVIATION 1.14 |
| Subjective Norms by adolescents | 4.12 Units on a scale STANDARD_DEVIATION 0.79 | 4.19 Units on a scale STANDARD_DEVIATION 0.75 | 4.16 Units on a scale STANDARD_DEVIATION 0.77 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 330 | 0 / 330 |
| serious Total, serious adverse events | 0 / 330 | 0 / 330 |
Outcome results
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.
Time frame: Baseline - 12 months
Population: All participants for whom parent-adolescent sexual risk communication (parental perspective) were recorded at baseline and 12 months.~Note: for health promotion arm - 1 missing data at baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parental Communication Intervention | Change From Baseline to 12 Months in Parent - Adolescent Sexual Risk Communication (Parental Perspective) | .52 units on a scale | Standard Deviation 1.02 |
| Health Promotion Control Condition. | Change From Baseline to 12 Months in Parent - Adolescent Sexual Risk Communication (Parental Perspective) | .27 units on a scale | Standard Deviation 0.97 |
Comparison: The intervention effect of sexual risk communication (primary outcome in parents) controlling for self-efficacy as a mediator from baseline through 12 months was examined using longitudinal general estimating equations (GEE) modeling, with the Health promotion control condition as the reference category and adjusting for baseline sexual risk communication and average monthly income.p-value: 0.022995% CI: [0.0022, 0.0285]GEE modeling
Comparison: The intervention effect of sexual risk communication (primary outcome in parents) controlling for sexual communication attitudes as a mediator from baseline through 12 months was examined using longitudinal general estimating equations (GEE) modeling, with the Health promotion control condition as the reference category and adjusting for baseline sexual risk communication and average monthly income.p-value: 0.024995% CI: [0.0019, 0.0282]GEE modeling
Comparison: The intervention effect of sexual risk communication (primary outcome in parents) controlling for subjective norms as a mediator from baseline through 12 months was examined using longitudinal general estimating equations (GEE) modeling, with the Health promotion control condition as the reference category and adjusting for baseline sexual risk communication and average monthly income.p-value: 0.020495% CI: [0.0025, 0.0292]GEE modeling
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.
Time frame: Baseline - 3 months
Population: All participants for whom parent-adolescent sexual risk communication (parental perspective) were recorded at baseline and 3 months.~Note: for Parental communication intervention arm - 2 missing data points at 3 months); for health promotion arm - 1 missing data at baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parental Communication Intervention | Change From Baseline to 3 Months in Parent - Adolescent Sexual Risk Communication (Parental Perspective) | 0.54 units on a scale | Standard Deviation 0.96 |
| Health Promotion Control Condition. | Change From Baseline to 3 Months in Parent - Adolescent Sexual Risk Communication (Parental Perspective) | 0.28 units on a scale | Standard Deviation 0.81 |
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.
Time frame: Baseline - 6 months
Population: All participants for whom parent-adolescent sexual risk communication (parental perspective) were recorded at baseline and 6 months.~Note: for health promotion arm - 1 missing data at baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parental Communication Intervention | Change From Baseline to 6 Months in Parent - Adolescent Sexual Risk Communication (Parental Perspective) | .49 units on a scale | Standard Deviation 0.95 |
| Health Promotion Control Condition. | Change From Baseline to 6 Months in Parent - Adolescent Sexual Risk Communication (Parental Perspective) | .21 units on a scale | Standard Deviation 0.96 |