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| ID | Type | Description | Link |
|---|---|---|---|
| 7R01NR013505 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
| University of Puerto Rico | OTHER |
| Yale University | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parental communication intervention | Experimental | The parental experimental intervention consists of a 60-minute web-based intervention consisting of several modules. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonia M Villarruel, PhD, RN | University of Pennsylvania | Principal Investigator |
| Nelson Varas-Diaz, PhD | University of Puerto Rico | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21116466 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A total of 660 parent/adolescent dyads (N=1,320) were randomized and met the following criteria: 1) agreed to engage in the study as a dyad, and 2) adolescent was between 13 and 17 years of age. We did not exclude parents or adolescents based on their literacy or computer literacy.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Between 18 and 65 years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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) | Posted | Mean | Standard Deviation | units on a scale | Baseline - 3 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Antonia M. Villarruel | University of Pennsylvania School of Nursing | 2158988283 | amvillar@nursing.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 3, 2015 | Apr 23, 2019 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D007239 | Infections |
| D012749 | Sexually Transmitted Diseases |
| D057545 | Social Stigma |
| D003075 | Coitus |
| D012725 | Sexual Behavior |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
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|
| 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. |
|
| Baseline - 12 months |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| Years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Child's Sex | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Partner | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Employment Outside of Home | Count of Participants | Participants |
|
| Number of Work Hours per week | Mean | Standard Deviation | Hours |
|
| Average Monthly Income | Count of Participants | Participants |
|
| Government Assistance | Count of Participants | Participants |
|
| Monthly Government Assistance Income | Mean | Standard Deviation | Currency, US dollars |
|
| Number of Children in House | Mean | Standard Deviation | Child |
|
| Program Location | Count of Participants | Participants |
|
| Parents' Computer Comfort | Survey measure to assess parents' comfort with using the computer. Scale used was: very comfortable, somewhat comfortable, somewhat uncomfortable, very uncomfortable. | Count of Participants | Participants |
|
| Parents' Ease/Difficulty Finding a Computer | Survey question to measure parents' ease or difficulty in finding a computer to use. Scale was very easy, easy, difficult, very difficult. | Count of Participants | Participants |
|
| General Communication between parent and adolescent | All items are based on parental self-report and measured with 5-point Likert scales (range 1-5), where a higher score indicates more communication when talking about general topics. This measure was 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. | Mean | Standard Deviation | Units on a scale |
|
| Sexual Risk Communication between parent and adolescent | All items are based on parental self-report and measured with 5-point Likert scales (range 1-5), where a higher score indicates more communication when talking about sexual risk. This measure was 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. | Mean | Standard Deviation | Units on a scale |
|
| Sexual Prevention Communication between parent and adolescent | All items are based on parental self-report and measured with 5-point Likert scales (range 1-5), where a higher score indicates more communication when talking about sexual prevention. This measure was 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. | Mean | Standard Deviation | Units on a scale |
|
| Sexual Protection Communication between parents and adolescents | All items are based on parental self-report and measured with 5-point Likert scales (range 1-5), where a higher score indicates more communication when talking about sexual protection. This measure was 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. | Mean | Standard Deviation | Units on a scale |
|
| Sexual Peer Pressure between parent and adolescent | All items are based on parental self-report and measured with 5-point Likert scales (range 1-5), where a higher score indicates more communication when talking about sexual peer pressure. This measure was 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. | Mean | Standard Deviation | Units on a scale |
|
| Comfort with Communication between parent and adolescent | All items are based on parental self-report and measured with 5-point Likert scales (range 1-5), where a higher score indicates more comfort with communication. This measure was 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. | Mean | Standard Deviation | Units on a scale |
|
| Sexual Communication Attitudes by adolescents | All items are based on adolescent self-report and measured with 5-point Likert scales (range 1-5), where a higher score indicates more communication when talking about sexual communication attitudes. This measure was 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. | Mean | Standard Deviation | Units on a scale |
|
| Subjective Norms by adolescents | All items are based on adolescent self-report and measured with 5-point Likert scales (range 1-5), where a higher score indicates more communication when talking about subjective norms. This measure was 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. | Mean | Standard Deviation | Units on a scale |
|
| Self-Efficacy by adolescents | All items are based on adolescent self-report and measured with 5-point Likert scales (range 1-5), where a higher score indicates more communication when talking about self-efficacy. This measure was 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. | Mean | Standard Deviation | Units on a scale |
|
| Sexual Communication Intentions by adolescents | All items are based on adolescent self-report and measured with 5-point Likert scales (range 1-5), where a higher score indicates more communication when talking about sexual communication intentions. This measure was 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. | Mean | Standard Deviation | Units on a scale |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | 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. |
| OG001 | 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. |
|
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| 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. | 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) | Posted | Mean | Standard Deviation | units on a scale | Baseline - 6 months |
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| 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. | 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) | Posted | Mean | Standard Deviation | units on a scale | Baseline - 12 months |
|
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|
| 0 |
| 330 |
| 0 |
| 330 |
| EG001 | 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. | 0 | 330 | 0 | 330 |
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| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012919 | Social Behavior |
| D001519 | Behavior |
[Not specified]
| Other |
[Not specified] |
| 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. | GEE modeling | P-value and estimate rely on group x time interaction effect on primary outcome when controlling for sexual communication attitudes. Same method B&K | 0.0249 | Statistical significance taken at the 0.05 level | Slope | 0.0151 | Standard Error of the Mean | 0.0067 | 2-Sided | 95 | 0.0019 | 0.0282 | [Not specified] | Other | [Not specified] |
| 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. | GEE modeling | Reported P-value and estimate rely on the group x time interaction effect on primary outcome when controlling for subjective norms. Same method B&K | 0.0204 | Statistical significance taken at the 0.05 level | Slope | 0.0158 | Standard Error of the Mean | 0.0068 | 2-Sided | 95 | 0.0025 | 0.0292 | [Not specified] | Other | [Not specified] |