Trial Outcomes & Findings for Puerto Rico Cuidalos Parent-adolescent Program (NCT NCT03063385)

Last Updated: 2019-10-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

660 participants

Primary outcome timeframe

Baseline - 3 months

Results posted on

2019-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	330	330
Overall Study 3-month Follow-up	257	259
Overall Study 6-month Follow-up	265	259
Overall Study 12-month Follow-up	243	254
Overall Study COMPLETED	243	254
Overall Study NOT COMPLETED	87	76

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Puerto Rico Cuidalos Parent-adolescent Program

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Parental Communication Intervention n=330 Participants 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.	Health Promotion Control Condition. n=330 Participants 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.	Total n=660 Participants Total of all reporting groups
Age, Continuous Adults	42.41 Years STANDARD_DEVIATION 8.17 • n=99 Participants	42.62 Years STANDARD_DEVIATION 8.34 • n=107 Participants	42.52 Years STANDARD_DEVIATION 8.25 • n=206 Participants
Age, Continuous Adolescents	14.52 Years STANDARD_DEVIATION 1.26 • n=99 Participants	14.57 Years STANDARD_DEVIATION 1.33 • n=107 Participants	14.55 Years STANDARD_DEVIATION 1.29 • n=206 Participants
Sex/Gender, Customized Female	296 Participants n=99 Participants	295 Participants n=107 Participants	591 Participants n=206 Participants
Sex/Gender, Customized Male	32 Participants n=99 Participants	35 Participants n=107 Participants	67 Participants n=206 Participants
Sex/Gender, Customized Missing	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	179 Participants n=99 Participants	184 Participants n=107 Participants	363 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=99 Participants	5 Participants n=107 Participants	11 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	145 Participants n=99 Participants	141 Participants n=107 Participants	286 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	9 Participants n=99 Participants	7 Participants n=107 Participants	16 Participants n=206 Participants
Race (NIH/OMB) Asian	3 Participants n=99 Participants	2 Participants n=107 Participants	5 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	35 Participants n=99 Participants	42 Participants n=107 Participants	77 Participants n=206 Participants
Race (NIH/OMB) White	89 Participants n=99 Participants	85 Participants n=107 Participants	174 Participants n=206 Participants
Race (NIH/OMB) More than one race	24 Participants n=99 Participants	24 Participants n=107 Participants	48 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	170 Participants n=99 Participants	170 Participants n=107 Participants	340 Participants n=206 Participants
Region of Enrollment Puerto Rico	330 Participants n=99 Participants	330 Participants n=107 Participants	660 Participants n=206 Participants
Child's Sex Female	174 Participants n=99 Participants	168 Participants n=107 Participants	342 Participants n=206 Participants
Child's Sex Male	154 Participants n=99 Participants	162 Participants n=107 Participants	316 Participants n=206 Participants
Child's Sex Missing	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Marital Status Single	98 Participants n=99 Participants	89 Participants n=107 Participants	187 Participants n=206 Participants
Marital Status Married	127 Participants n=99 Participants	142 Participants n=107 Participants	269 Participants n=206 Participants
Marital Status Separated	9 Participants n=99 Participants	13 Participants n=107 Participants	22 Participants n=206 Participants
Marital Status Divorced	51 Participants n=99 Participants	42 Participants n=107 Participants	93 Participants n=206 Participants
Marital Status Widowed	5 Participants n=99 Participants	10 Participants n=107 Participants	15 Participants n=206 Participants
Marital Status Live in Partner	38 Participants n=99 Participants	34 Participants n=107 Participants	72 Participants n=206 Participants
Marital Status Missing	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Partner Yes	198 Participants n=99 Participants	214 Participants n=107 Participants	412 Participants n=206 Participants
Partner No	129 Participants n=99 Participants	116 Participants n=107 Participants	245 Participants n=206 Participants
Partner Missing	3 Participants n=99 Participants	0 Participants n=107 Participants	3 Participants n=206 Participants
Education Did not complete high school	32 Participants n=99 Participants	40 Participants n=107 Participants	72 Participants n=206 Participants
Education Completed high school	95 Participants n=99 Participants	95 Participants n=107 Participants	190 Participants n=206 Participants
Education Did not complete college	50 Participants n=99 Participants	52 Participants n=107 Participants	102 Participants n=206 Participants
Education Completed college	151 Participants n=99 Participants	141 Participants n=107 Participants	292 Participants n=206 Participants
Education Missing	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Employment Outside of Home Yes	128 Participants n=99 Participants	129 Participants n=107 Participants	257 Participants n=206 Participants
Employment Outside of Home No	200 Participants n=99 Participants	201 Participants n=107 Participants	401 Participants n=206 Participants
Employment Outside of Home Missing	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Number of Work Hours per week	33.41 Hours STANDARD_DEVIATION 13.35 • n=99 Participants	31.62 Hours STANDARD_DEVIATION 13.35 • n=107 Participants	32.50 Hours STANDARD_DEVIATION 13.35 • n=206 Participants
Average Monthly Income <$300	22 Participants n=99 Participants	29 Participants n=107 Participants	51 Participants n=206 Participants
Average Monthly Income $300-$799	22 Participants n=99 Participants	24 Participants n=107 Participants	46 Participants n=206 Participants
Average Monthly Income $800-$1699	24 Participants n=99 Participants	40 Participants n=107 Participants	64 Participants n=206 Participants
Average Monthly Income ≥$1700	36 Participants n=99 Participants	18 Participants n=107 Participants	54 Participants n=206 Participants
Average Monthly Income Unknown	226 Participants n=99 Participants	219 Participants n=107 Participants	445 Participants n=206 Participants
Government Assistance Yes	210 Participants n=99 Participants	202 Participants n=107 Participants	412 Participants n=206 Participants
Government Assistance No	118 Participants n=99 Participants	128 Participants n=107 Participants	246 Participants n=206 Participants
Government Assistance Missing	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Monthly Government Assistance Income	568.78 Currency, US dollars STANDARD_DEVIATION 854.96 • n=99 Participants	537.16 Currency, US dollars STANDARD_DEVIATION 650.46 • n=107 Participants	553.32 Currency, US dollars STANDARD_DEVIATION 761.09 • n=206 Participants
Number of Children in House	1.53 Child STANDARD_DEVIATION 0.76 • n=99 Participants	1.56 Child STANDARD_DEVIATION 0.72 • n=107 Participants	1.54 Child STANDARD_DEVIATION 0.74 • n=206 Participants
Program Location Community Agency	62 Participants n=99 Participants	58 Participants n=107 Participants	120 Participants n=206 Participants
Program Location School	172 Participants n=99 Participants	165 Participants n=107 Participants	337 Participants n=206 Participants
Program Location Home	46 Participants n=99 Participants	58 Participants n=107 Participants	104 Participants n=206 Participants
Program Location Other Location	46 Participants n=99 Participants	46 Participants n=107 Participants	92 Participants n=206 Participants
Program Location Missing	4 Participants n=99 Participants	3 Participants n=107 Participants	7 Participants n=206 Participants
Parents' Computer Comfort Very comfortable	226 Participants n=99 Participants	233 Participants n=107 Participants	459 Participants n=206 Participants
Parents' Computer Comfort Somewhat comfortable	78 Participants n=99 Participants	73 Participants n=107 Participants	151 Participants n=206 Participants
Parents' Computer Comfort Somewhat uncomfortable	20 Participants n=99 Participants	15 Participants n=107 Participants	35 Participants n=206 Participants
Parents' Computer Comfort Very uncomfortable	4 Participants n=99 Participants	7 Participants n=107 Participants	11 Participants n=206 Participants
Parents' Computer Comfort Missing	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Parents' Ease/Difficulty Finding a Computer Very easy	140 Participants n=99 Participants	131 Participants n=107 Participants	271 Participants n=206 Participants
Parents' Ease/Difficulty Finding a Computer Easy	115 Participants n=99 Participants	125 Participants n=107 Participants	240 Participants n=206 Participants
Parents' Ease/Difficulty Finding a Computer Difficult	52 Participants n=99 Participants	57 Participants n=107 Participants	109 Participants n=206 Participants
Parents' Ease/Difficulty Finding a Computer Very difficult	20 Participants n=99 Participants	15 Participants n=107 Participants	35 Participants n=206 Participants
Parents' Ease/Difficulty Finding a Computer Missing	3 Participants n=99 Participants	2 Participants n=107 Participants	5 Participants n=206 Participants
General Communication between parent and adolescent	3.84 Units on a scale STANDARD_DEVIATION 0.62 • n=99 Participants	3.88 Units on a scale STANDARD_DEVIATION 0.59 • n=107 Participants	3.86 Units on a scale STANDARD_DEVIATION 0.60 • n=206 Participants
Sexual Risk Communication between parent and adolescent	3.12 Units on a scale STANDARD_DEVIATION 1.12 • n=99 Participants	3.31 Units on a scale STANDARD_DEVIATION 1.16 • n=107 Participants	3.22 Units on a scale STANDARD_DEVIATION 1.14 • n=206 Participants
Sexual Prevention Communication between parent and adolescent	3.07 Units on a scale STANDARD_DEVIATION 1.31 • n=99 Participants	3.25 Units on a scale STANDARD_DEVIATION 1.35 • n=107 Participants	3.16 Units on a scale STANDARD_DEVIATION 1.33 • n=206 Participants
Sexual Protection Communication between parents and adolescents	2.74 Units on a scale STANDARD_DEVIATION 1.36 • n=99 Participants	2.93 Units on a scale STANDARD_DEVIATION 1.36 • n=107 Participants	2.83 Units on a scale STANDARD_DEVIATION 1.36 • n=206 Participants
Sexual Peer Pressure between parent and adolescent	3.52 Units on a scale STANDARD_DEVIATION 1.21 • n=99 Participants	3.71 Units on a scale STANDARD_DEVIATION 1.29 • n=107 Participants	3.62 Units on a scale STANDARD_DEVIATION 1.25 • n=206 Participants
Comfort with Communication between parent and adolescent	3.50 Units on a scale STANDARD_DEVIATION 0.61 • n=99 Participants	3.51 Units on a scale STANDARD_DEVIATION 0.60 • n=107 Participants	3.5 Units on a scale STANDARD_DEVIATION 0.60 • n=206 Participants
Sexual Communication Attitudes by adolescents	3.71 Units on a scale STANDARD_DEVIATION 0.51 • n=99 Participants	3.77 Units on a scale STANDARD_DEVIATION 0.46 • n=107 Participants	3.74 Units on a scale STANDARD_DEVIATION 0.49 • n=206 Participants
Subjective Norms by adolescents	4.12 Units on a scale STANDARD_DEVIATION 0.79 • n=99 Participants	4.19 Units on a scale STANDARD_DEVIATION 0.75 • n=107 Participants	4.16 Units on a scale STANDARD_DEVIATION 0.77 • n=206 Participants
Self-Efficacy by adolescents	3.77 Units on a scale STANDARD_DEVIATION 0.90 • n=99 Participants	3.89 Units on a scale STANDARD_DEVIATION 0.91 • n=107 Participants	3.83 Units on a scale STANDARD_DEVIATION 0.91 • n=206 Participants
Sexual Communication Intentions by adolescents	4.02 Units on a scale STANDARD_DEVIATION 0.94 • n=99 Participants	4.00 Units on a scale STANDARD_DEVIATION 0.96 • n=107 Participants	4.01 Units on a scale STANDARD_DEVIATION 0.95 • n=206 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Parental Communication Intervention n=255 Participants 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.	Health Promotion Control Condition. n=258 Participants 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.
Change From Baseline to 3 Months in Parent - Adolescent Sexual Risk Communication (Parental Perspective)	0.54 units on a scale Standard Deviation .96	0.28 units on a scale Standard Deviation 0.81

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Parental Communication Intervention n=265 Participants 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.	Health Promotion Control Condition. n=258 Participants 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.
Change From Baseline to 6 Months in Parent - Adolescent Sexual Risk Communication (Parental Perspective)	.49 units on a scale Standard Deviation .95	.21 units on a scale Standard Deviation .96

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Parental Communication Intervention n=243 Participants 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.	Health Promotion Control Condition. n=253 Participants 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.
Change From Baseline to 12 Months in Parent - Adolescent Sexual Risk Communication (Parental Perspective)	.52 units on a scale Standard Deviation 1.02	.27 units on a scale Standard Deviation .97

Adverse Events

Parental Communication Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Health Promotion Control Condition.

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Antonia M. Villarruel

University of Pennsylvania School of Nursing

Phone: 2158988283

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place