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Family Based Prevention of Alcohol and Risky Sex for Older Teens

Web-based Family Prevention of Alcohol and Risky Sex for Older Teens

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03521115
Enrollment
411
Registered
2018-05-11
Start date
2013-04-01
Completion date
2017-05-28
Last updated
2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Abstinence, Alcohol Drinking, Alcohol; Harmful Use, Alcohol Impairment, Alcohol Intoxication, Alcohol Poison, Alcohol-Related Disorders, Alcohol Withdrawal, Relation, Interpersonal, Sex Behavior, Sexual Aggression, Sexual Harassment

Brief summary

An online, interactive web-based program for older teens and their parents is designed to address teen alcohol use and teen relationships. The parent-teen dyad both participate in the web-based program and engage in off-line discussion activities. This intervention promotes communication skills, refusal skills, and helps teens consider how to make healthy choices. A total of 411 family dyads (one parent, one teen) were recruited.

Detailed description

This purpose of this study is to develop an interactive, web-based prevention program for parents and older teens that focuses on teen use of alcohol and teen relationships. The study is designed as a randomized controlled trial. Specific Aim 1: To adapt two parent-based prevention strategies (Family Matters and Parent Handbook) to provide a family-based approach for addressing older teen alcohol related risk behaviors and sexual risk behaviors and sex in combination with alcohol use (hereafter called alcohol and/or sexual risk behaviors) using the web as the program delivery mode. Specific Aim 2: To test whether exposure to the program leads to expected changes in targeted teen beliefs and behaviors, including reductions in alcohol and/or sexual risk behaviors. Specific Aim 3: To examine whether program effects on teen alcohol and/or sexual risk behaviors are mediated through changes in intermediate program targeted beliefs (parents and teen) and behaviors (e.g., parent-teen--communication). Program fidelity and process measures may also mediate these outcomes. Phase I integrates and adapts the two parent-based approaches and creates a web-based interactive delivery of materials. Expert panels, focus groups, and usability assessments will inform the process. Phase II is an RCT with 400 families with the web-based intervention. Surveys will be conducted at baseline, and for three follow-up periods (6, 12, & 18 months). Analyses will examine teen outcomes related to alcohol and/or sexual risk behaviors. Changes in mediators directly impacted by the program for both teens and parents will be examined. Process and fidelity information will be collected and assessed. A web-based prevention strategy supporting parents and teens, is significant and timely. Parents and teens will use the internet to make health decisions. This program is uniquely different from other programs be-cause it addresses teens at high risk for alcohol and/or sexual risk behaviors. Further, the strategy involves both parents and teens through an interactive framework. The approach utilizes the strengths of Family Matters which promotes specific exercises and activities between parents and teens and the strengths of the Parent Handbook which addresses issues of importance to this age range.

Interventions

BEHAVIORALSmart Choices 4 Teens

This is a web-based prevention program designed to convey information about alcohol and relationships and the types of choices that they are making regarding these topics. General communications was another core element of the program that provided parents and teens with some key elements of talking to each other.

Sponsors

Klein Buendel, Inc.
CollaboratorINDUSTRY
University of New Mexico
CollaboratorOTHER
Pacific Institute for Research and Evaluation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

Parents and Teens were either assigned to the full intervention or provided with didactic materials available on the internet. Family is considered the level of participant

Intervention model description

Randomized Controlled Trial

Eligibility

Sex/Gender
ALL
Age
16 Years to 17 Years
Healthy volunteers
Yes

Inclusion criteria

* One parent and the teen both had to enroll in the study.

Exclusion criteria

* Non-English speaking

Design outcomes

Primary

MeasureTime frameDescription
Number of Teens Using Any Alcohol During Past 6 MonthsMeasured at baseline, 6, 12, & 18 monthsHave you had a drink of alcohol in the past 6 months? (A drink is a glass of wine, a can of beer, a wine cooler, a shot glass of liquor, or a mixed drink). (Response category yes=1/no=0). Range is 0-1. More frequent drinking is a worse outcome.
Frequency of Teen Alcohol Use Over Most Recent 30 Days Within Past 6 MonthsMeasured at 6, 12, & 18 monthsOver the past 30 days, how many times have you had a drink of alcohol? (response categories: 0=none, 1=once, 2=2-3 times, 3= once a week, 4=2-3 times a week. Range is 0-4.Higher score is more frequent drinking and a worse outcome.
Quantity of Alcohol Consumed by Teens on Drinking Days for the Most Recent 30 Days Within the Past Six MonthsMeasured at baseline, 6, 12, & 18 monthsOver the past 30 days, how many drinks did you usually have on days you drank? (response categories: 0= less than one, 1, 2, 3, 4, 5, 6, 7= more than six). Range is 0-7. Higher scores represent more drinking and worse outcome.
Count of Teens Who Were Drunk or Very, Very High During the Past 6 MonthsMeasured at 6, 12, & 18 monthsOver the past 6 months, how many times have you gotten drunk or very, very high on alcohol? (Response categories: 0=none, 1=once a month, 2=2-3 times a month, 3=once a week, 4= 2-3 times a week, 5=daily or almost daily). Range is 0-5. Higher score represents more drunkenness and a worse outcome.
Frequency of Parental Approval for Teen Drinking (in Moderation)Measured at baseline, 6, 12, & 18 monthsHow often have you and your parent talked about drinking in moderation is okay (Response categories 1=Never, 2=Occasionally, 3=Sometimes, 4= Often, 5 = Very often). Range is 1-5 and higher scores means more parental approval of teen drinking and is a worse outcome.
Frequency of Teen- Parent Communications Regarding SexMeasured at baseline, 6, 12, & 18 monthsOverall, how often you have talked to your parent about sex? (1=Never, 2=Occasionally, 3=Sometimes, 4=Often, 5= Very often). Range 1-5. Higher scores represent a better outcome.
Frequency of Teen-parent Communications About Specific Sexual TopicsMeasured at baseline, 6, 12, & 18 monthsAverage frequency created across 4 different sex topics (i. how being in a relationship might divert me from achieving my goals at school, ii. how embarrassing it would be if I caught an STI -sexually transmitted infection, iii. sexual relationships can impact health, iv. how pregnancy would be embarassing) with responses being never=1, occasionally=2, sometimes=3, often=4, very often=5 for a full range of 1-5. Across the 4 different sex topics the sums ranged from 4-20 and average was created by dividing the score by 4, with higher scores indicating more both topics and higher frequency of discussions taking place for a final full range of 1-5.
Count of Teen-parent Communications Regarding Delaying Sexual ActivityMeasured at baseline, 6, 12, & 18 monthsCommunications regarding delaying sex based upon three questions with yes=1/no=0 responses summed: Have your parents told you that (i)you should not have sex, (ii)you should not be in a serious relationship while still in high school, (iii)you should not have sex because your religion or values forbid sex outside of marriage. Higher scores indicate more communications about delaying sex. Range is 0-3. Higher scores represent a better outcome.
Count of Teen-parent Communications Regarding Health Risks Associated With SexPast 6, 12, & 18 monthsParent-teen communications score regarding health risks with sex were based upon two items: discussion that sex can result in pregnancy (y=1/n=0) and sex can result in sexually transmitted infections (y=1/n=0). Range is 0-2. Higher scores represent a better outcome.
Count of Parental Dating RulesMeasured at baseline, 6, 12, & 18 monthsParental rules regarding dating were based upon summing the yes (=1) response to 15 possible rules: parents must meet date, check in/call during date, parents must know destination, parents must know change of plans, address and phone number needed for parties, no dates on school nights, no sex, no sigle dates, curfew, only agreed upon locations, use good judgment, be gentleman/lady, leave if uncomfortable (y=1/n=0). Range is 0-15. Higher scores represent better outcomes.
Count of Teens Who Have Ever Had Sex Over Their LifetimeMeasured at baseline, 6, 12, & 18 monthsHave you ever had sex (vaginal, oral, or anal)? (responses were yes=1/no=0). Range was 0-1. Higher score is worse outcome risk.

Countries

United States

Participant flow

Recruitment details

November 2014-November 2015 Recruited national sample from two panel vendors

Pre-assignment details

To be eligible, one teen and one parent had to be willing to participate. Enrollment was considered complete after the participants completed consent and baseline surveys. A total of 559 families were eligible and 148 of eligible families declined to participate, leaving a total of 411 families.

Participants by arm

ArmCount
Smart Choices 4 Teens
A web-based intervention consisting of 3 main components (Communication, Alcohol, Relationships) provided to both parents and teens was completed by parents and teens individually. At the end of each component, discussion guidelines were given to promote communications and to offer skill building practices between parent and teen regarding the component topic. Both the parent and teen were required to complete the component and discussion before moving to the next component. Smart Choices 4 Teens: This is a web-based prevention program designed to convey information about alcohol and relationships and the types of choices that they are making regarding these topics. General communications was another core element of the program that provided parents and teens with some key elements of talking to each other.
206
Control Condition
This group was provided with websites where information was available regarding the same topics.
205
Total411

Withdrawals & dropouts

PeriodReasonFG000FG001
Time 1 Survey (6 Months Post Baseline)Lost to Follow-up5640
Time 2 Survey (12 Months Post Baseline)Lost to Follow-up31

Baseline characteristics

CharacteristicControl ConditionSmart Choices 4 TeensTotal
Age, Continuous
parent age
43.75 years
STANDARD_DEVIATION 6.385
43.73 years
STANDARD_DEVIATION 7.039
43.74 years
STANDARD_DEVIATION 6.711
Age, Continuous
teen age
16.34 years
STANDARD_DEVIATION 0.474
16.40 years
STANDARD_DEVIATION 0.492
16.37 years
STANDARD_DEVIATION 0.483
Any Alcohol Use26 Participants21 Participants47 Participants
Communication regarding health risks1.81 units on a scale
STANDARD_DEVIATION 0.53
1.85 units on a scale
STANDARD_DEVIATION 0.46
1.83 units on a scale
STANDARD_DEVIATION 0.5
Communications regarding delaying sex1.33 units on a scale
STANDARD_DEVIATION 1.1
1.23 units on a scale
STANDARD_DEVIATION 1.03
1.28 units on a scale
STANDARD_DEVIATION 1.07
Ethnicity (NIH/OMB)
Parent Ethnicity
Hispanic or Latino
14 Participants16 Participants30 Participants
Ethnicity (NIH/OMB)
Parent Ethnicity
Not Hispanic or Latino
190 Participants190 Participants380 Participants
Ethnicity (NIH/OMB)
Parent Ethnicity
Unknown or Not Reported
1 Participants0 Participants1 Participants
Ethnicity (NIH/OMB)
Teen Ethnicity
Hispanic or Latino
14 Participants21 Participants35 Participants
Ethnicity (NIH/OMB)
Teen Ethnicity
Not Hispanic or Latino
190 Participants179 Participants369 Participants
Ethnicity (NIH/OMB)
Teen Ethnicity
Unknown or Not Reported
1 Participants6 Participants7 Participants
Ever had sex48 Participants55 Participants103 Participants
Frequency for Topic Specific sexual activity2.62 units on a scale
STANDARD_DEVIATION 1.09
2.68 units on a scale
STANDARD_DEVIATION 1.06
2.62 units on a scale
STANDARD_DEVIATION 1.09
Frequency of Alcohol Use.17 units on a scale
STANDARD_DEVIATION 0.54
.21 units on a scale
STANDARD_DEVIATION 0.59
.19 units on a scale
STANDARD_DEVIATION 0.57
Number of Dating rules11.32 units on a scale
STANDARD_DEVIATION 3.1
11.19 units on a scale
STANDARD_DEVIATION 3.16
11.26 units on a scale
STANDARD_DEVIATION 3.12
Number of times drunk or very, very high.24 units on a scale
STANDARD_DEVIATION 0.74
.29 units on a scale
STANDARD_DEVIATION 0.89
.26 units on a scale
STANDARD_DEVIATION 0.82
Overall communication about sex2.55 units on a scale
STANDARD_DEVIATION 1.11
2.65 units on a scale
STANDARD_DEVIATION 1.05
2.60 units on a scale
STANDARD_DEVIATION 1.08
Parental approval of teen drinking (in moderation)2.08 units on a scale
STANDARD_DEVIATION 1.3
2.05 units on a scale
STANDARD_DEVIATION 1.36
2.07 units on a scale
STANDARD_DEVIATION 1.33
Quantity of alcohol consumed on drinking days.26 units on a scale
STANDARD_DEVIATION 1.05
.27 units on a scale
STANDARD_DEVIATION 0.93
.27 units on a scale
STANDARD_DEVIATION 0.99
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants2 Participants3 Participants
Race (NIH/OMB)
Asian
4 Participants4 Participants8 Participants
Race (NIH/OMB)
Black or African American
24 Participants24 Participants48 Participants
Race (NIH/OMB)
More than one race
11 Participants13 Participants24 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
7 Participants2 Participants9 Participants
Race (NIH/OMB)
White
157 Participants161 Participants318 Participants
Region of Enrollment
United States
205 participants206 participants411 participants
Sex: Female, Male
Parent Gender
Female
175 Participants173 Participants348 Participants
Sex: Female, Male
Parent Gender
Male
30 Participants33 Participants63 Participants
Sex: Female, Male
Teen Gender
Female
117 Participants109 Participants226 Participants
Sex: Female, Male
Teen Gender
Male
87 Participants96 Participants183 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2060 / 205
other
Total, other adverse events
0 / 2060 / 205
serious
Total, serious adverse events
0 / 2060 / 205

Outcome results

Primary

Count of Parental Dating Rules

Parental rules regarding dating were based upon summing the yes (=1) response to 15 possible rules: parents must meet date, check in/call during date, parents must know destination, parents must know change of plans, address and phone number needed for parties, no dates on school nights, no sex, no sigle dates, curfew, only agreed upon locations, use good judgment, be gentleman/lady, leave if uncomfortable (y=1/n=0). Range is 0-15. Higher scores represent better outcomes.

Time frame: Measured at baseline, 6, 12, & 18 months

Population: There are 3 follow-up periods and the numbers analyzed vary across these follow-up periods

ArmMeasureGroupValue (MEAN)Dispersion
Smart Choices 4 TeensCount of Parental Dating RulesDating rules, teen report, 12 month follow-up11.04 score on a scaleStandard Deviation 3.47
Smart Choices 4 TeensCount of Parental Dating RulesDating Rules-Teen report 6 month follow-up11.48 score on a scaleStandard Deviation 2.97
Smart Choices 4 TeensCount of Parental Dating RulesDating rules, teen report, 18 month follow-up11.01 score on a scaleStandard Deviation 3.29
Assigned Intervention, no ExposuresCount of Parental Dating RulesDating rules, teen report, 12 month follow-up10.42 score on a scaleStandard Deviation 3.57
Assigned Intervention, no ExposuresCount of Parental Dating RulesDating Rules-Teen report 6 month follow-up10.18 score on a scaleStandard Deviation 3.91
Assigned Intervention, no ExposuresCount of Parental Dating RulesDating rules, teen report, 18 month follow-up9.53 score on a scaleStandard Deviation 3.59
Control ConditionCount of Parental Dating RulesDating Rules-Teen report 6 month follow-up10.77 score on a scaleStandard Deviation 3.57
Control ConditionCount of Parental Dating RulesDating rules, teen report, 18 month follow-up10.08 score on a scaleStandard Deviation 4.09
Control ConditionCount of Parental Dating RulesDating rules, teen report, 12 month follow-up10.72 score on a scaleStandard Deviation 3.44
Comparison: Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.p-value: <0.05generalized estimating equations
Primary

Count of Teen-parent Communications Regarding Delaying Sexual Activity

Communications regarding delaying sex based upon three questions with yes=1/no=0 responses summed: Have your parents told you that (i)you should not have sex, (ii)you should not be in a serious relationship while still in high school, (iii)you should not have sex because your religion or values forbid sex outside of marriage. Higher scores indicate more communications about delaying sex. Range is 0-3. Higher scores represent a better outcome.

Time frame: Measured at baseline, 6, 12, & 18 months

Population: The three rows represent different follow-up periods and there are different response rates across follow-up periods.

ArmMeasureGroupValue (MEAN)Dispersion
Smart Choices 4 TeensCount of Teen-parent Communications Regarding Delaying Sexual ActivityCommunication regarding delay sex at 12 month follow-up1.09 score on a scaleStandard Deviation 1.11
Smart Choices 4 TeensCount of Teen-parent Communications Regarding Delaying Sexual ActivityCommunication regarding delay sex at 6 month follow-up1.13 score on a scaleStandard Deviation 1.09
Smart Choices 4 TeensCount of Teen-parent Communications Regarding Delaying Sexual ActivityCommunication regarding delay sex at 18 month follow-up0.98 score on a scaleStandard Deviation 1.04
Assigned Intervention, no ExposuresCount of Teen-parent Communications Regarding Delaying Sexual ActivityCommunication regarding delay sex at 12 month follow-up1.02 score on a scaleStandard Deviation 1.08
Assigned Intervention, no ExposuresCount of Teen-parent Communications Regarding Delaying Sexual ActivityCommunication regarding delay sex at 6 month follow-up0.85 score on a scaleStandard Deviation 0.98
Assigned Intervention, no ExposuresCount of Teen-parent Communications Regarding Delaying Sexual ActivityCommunication regarding delay sex at 18 month follow-up0.75 score on a scaleStandard Deviation 1
Control ConditionCount of Teen-parent Communications Regarding Delaying Sexual ActivityCommunication regarding delay sex at 6 month follow-up0.98 score on a scaleStandard Deviation 1.04
Control ConditionCount of Teen-parent Communications Regarding Delaying Sexual ActivityCommunication regarding delay sex at 18 month follow-up0.95 score on a scaleStandard Deviation 1.11
Control ConditionCount of Teen-parent Communications Regarding Delaying Sexual ActivityCommunication regarding delay sex at 12 month follow-up1.07 score on a scaleStandard Deviation 1.1
Comparison: Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.p-value: >0.1generalized estimating equations
Primary

Count of Teen-parent Communications Regarding Health Risks Associated With Sex

Parent-teen communications score regarding health risks with sex were based upon two items: discussion that sex can result in pregnancy (y=1/n=0) and sex can result in sexually transmitted infections (y=1/n=0). Range is 0-2. Higher scores represent a better outcome.

Time frame: Past 6, 12, & 18 months

Population: Each row represents a different follow-up time period and the number of respondents varied across the time periods.

ArmMeasureGroupValue (MEAN)Dispersion
Smart Choices 4 TeensCount of Teen-parent Communications Regarding Health Risks Associated With SexCommunications on Health Risks at 12 month Follow-up1.53 score on a scaleStandard Deviation 0.77
Smart Choices 4 TeensCount of Teen-parent Communications Regarding Health Risks Associated With SexCommunications on Health Risks at 6 month follow-up1.63 score on a scaleStandard Deviation 0.71
Smart Choices 4 TeensCount of Teen-parent Communications Regarding Health Risks Associated With SexCommunications on Health Risk at 18 month follow-up1.49 score on a scaleStandard Deviation 0.83
Assigned Intervention, no ExposuresCount of Teen-parent Communications Regarding Health Risks Associated With SexCommunications on Health Risks at 12 month Follow-up1.40 score on a scaleStandard Deviation 0.86
Assigned Intervention, no ExposuresCount of Teen-parent Communications Regarding Health Risks Associated With SexCommunications on Health Risks at 6 month follow-up1.35 score on a scaleStandard Deviation 0.89
Assigned Intervention, no ExposuresCount of Teen-parent Communications Regarding Health Risks Associated With SexCommunications on Health Risk at 18 month follow-up1.27 score on a scaleStandard Deviation 0.9
Control ConditionCount of Teen-parent Communications Regarding Health Risks Associated With SexCommunications on Health Risks at 6 month follow-up1.51 score on a scaleStandard Deviation 0.77
Control ConditionCount of Teen-parent Communications Regarding Health Risks Associated With SexCommunications on Health Risk at 18 month follow-up1.38 score on a scaleStandard Deviation 0.86
Control ConditionCount of Teen-parent Communications Regarding Health Risks Associated With SexCommunications on Health Risks at 12 month Follow-up1.54 score on a scaleStandard Deviation 0.79
Comparison: Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.p-value: >0.1generalized estimating equations
Primary

Count of Teens Who Have Ever Had Sex Over Their Lifetime

Have you ever had sex (vaginal, oral, or anal)? (responses were yes=1/no=0). Range was 0-1. Higher score is worse outcome risk.

Time frame: Measured at baseline, 6, 12, & 18 months

Population: The three rows reflect different follow-up periods, teens were lost to follow-up in subsequent waves

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Smart Choices 4 TeensCount of Teens Who Have Ever Had Sex Over Their Lifetimeever had sex at 12 month follow-up17 Participants
Smart Choices 4 TeensCount of Teens Who Have Ever Had Sex Over Their Lifetimeever had sex at 6 month follow-up17 Participants
Smart Choices 4 TeensCount of Teens Who Have Ever Had Sex Over Their Lifetimeever had sex at 18 month follow-up19 Participants
Assigned Intervention, no ExposuresCount of Teens Who Have Ever Had Sex Over Their Lifetimeever had sex at 12 month follow-up20 Participants
Assigned Intervention, no ExposuresCount of Teens Who Have Ever Had Sex Over Their Lifetimeever had sex at 6 month follow-up15 Participants
Assigned Intervention, no ExposuresCount of Teens Who Have Ever Had Sex Over Their Lifetimeever had sex at 18 month follow-up21 Participants
Control ConditionCount of Teens Who Have Ever Had Sex Over Their Lifetimeever had sex at 6 month follow-up37 Participants
Control ConditionCount of Teens Who Have Ever Had Sex Over Their Lifetimeever had sex at 18 month follow-up46 Participants
Control ConditionCount of Teens Who Have Ever Had Sex Over Their Lifetimeever had sex at 12 month follow-up39 Participants
Comparison: Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.p-value: >0.1Chi-squared
Primary

Count of Teens Who Were Drunk or Very, Very High During the Past 6 Months

Over the past 6 months, how many times have you gotten drunk or very, very high on alcohol? (Response categories: 0=none, 1=once a month, 2=2-3 times a month, 3=once a week, 4= 2-3 times a week, 5=daily or almost daily). Range is 0-5. Higher score represents more drunkenness and a worse outcome.

Time frame: Measured at 6, 12, & 18 months

Population: Within the experimental group, 49.5% completed the alcohol component of the intervention

ArmMeasureGroupValue (MEAN)Dispersion
Smart Choices 4 TeensCount of Teens Who Were Drunk or Very, Very High During the Past 6 Months12 month follow-up.08 score on a scaleStandard Deviation 0.35
Smart Choices 4 TeensCount of Teens Who Were Drunk or Very, Very High During the Past 6 Months6 month follow-up.10 score on a scaleStandard Deviation 0.4
Smart Choices 4 TeensCount of Teens Who Were Drunk or Very, Very High During the Past 6 Months18 month follow-up.21 score on a scaleStandard Deviation 0.61
Assigned Intervention, no ExposuresCount of Teens Who Were Drunk or Very, Very High During the Past 6 Months12 month follow-up.44 score on a scaleStandard Deviation 1.46
Assigned Intervention, no ExposuresCount of Teens Who Were Drunk or Very, Very High During the Past 6 Months6 month follow-up.26 score on a scaleStandard Deviation 0.96
Assigned Intervention, no ExposuresCount of Teens Who Were Drunk or Very, Very High During the Past 6 Months18 month follow-up.26 score on a scaleStandard Deviation 1
Control ConditionCount of Teens Who Were Drunk or Very, Very High During the Past 6 Months6 month follow-up.23 score on a scaleStandard Deviation 0.91
Control ConditionCount of Teens Who Were Drunk or Very, Very High During the Past 6 Months18 month follow-up.45 score on a scaleStandard Deviation 1.3
Control ConditionCount of Teens Who Were Drunk or Very, Very High During the Past 6 Months12 month follow-up.39 score on a scaleStandard Deviation 1.2
Comparison: 6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.p-value: <0.1Regression, Linear
Comparison: 12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.p-value: <0.05Regression, Linear
Comparison: 18 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. All controls were assigned 0 dosage.p-value: >0.1ANOVA
Primary

Frequency of Parental Approval for Teen Drinking (in Moderation)

How often have you and your parent talked about drinking in moderation is okay (Response categories 1=Never, 2=Occasionally, 3=Sometimes, 4= Often, 5 = Very often). Range is 1-5 and higher scores means more parental approval of teen drinking and is a worse outcome.

Time frame: Measured at baseline, 6, 12, & 18 months

Population: Across time, there was loss of sample at follow-up

ArmMeasureGroupValue (MEAN)Dispersion
Smart Choices 4 TeensFrequency of Parental Approval for Teen Drinking (in Moderation)12 month follow-up2.16 units on a scaleStandard Deviation 1.29
Smart Choices 4 TeensFrequency of Parental Approval for Teen Drinking (in Moderation)6 month follow-up1.99 units on a scaleStandard Deviation 1.31
Smart Choices 4 TeensFrequency of Parental Approval for Teen Drinking (in Moderation)18 month follow-up2.12 units on a scaleStandard Deviation 1.4
Assigned Intervention, no ExposuresFrequency of Parental Approval for Teen Drinking (in Moderation)12 month follow-up2.66 units on a scaleStandard Deviation 1.55
Assigned Intervention, no ExposuresFrequency of Parental Approval for Teen Drinking (in Moderation)6 month follow-up2.59 units on a scaleStandard Deviation 1.4
Assigned Intervention, no ExposuresFrequency of Parental Approval for Teen Drinking (in Moderation)18 month follow-up2.57 units on a scaleStandard Deviation 1.31
Control ConditionFrequency of Parental Approval for Teen Drinking (in Moderation)6 month follow-up2.26 units on a scaleStandard Deviation 1.35
Control ConditionFrequency of Parental Approval for Teen Drinking (in Moderation)18 month follow-up2.13 units on a scaleStandard Deviation 1.28
Control ConditionFrequency of Parental Approval for Teen Drinking (in Moderation)12 month follow-up2.19 units on a scaleStandard Deviation 1.27
Comparison: 6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.p-value: <0.05Regression, Linear
Comparison: 12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.p-value: >0.1Regression, Linear
Primary

Frequency of Teen Alcohol Use Over Most Recent 30 Days Within Past 6 Months

Over the past 30 days, how many times have you had a drink of alcohol? (response categories: 0=none, 1=once, 2=2-3 times, 3= once a week, 4=2-3 times a week. Range is 0-4.Higher score is more frequent drinking and a worse outcome.

Time frame: Measured at 6, 12, & 18 months

Population: Missing responses and teens lost at follow-up

ArmMeasureGroupValue (MEAN)Dispersion
Smart Choices 4 TeensFrequency of Teen Alcohol Use Over Most Recent 30 Days Within Past 6 Months12 month follow-up.09 units on a scaleStandard Deviation 0.36
Smart Choices 4 TeensFrequency of Teen Alcohol Use Over Most Recent 30 Days Within Past 6 Months6 month follow-up.16 units on a scaleStandard Deviation 0.56
Smart Choices 4 TeensFrequency of Teen Alcohol Use Over Most Recent 30 Days Within Past 6 Months18 month follow-up.31 units on a scaleStandard Deviation 0.69
Assigned Intervention, no ExposuresFrequency of Teen Alcohol Use Over Most Recent 30 Days Within Past 6 Months12 month follow-up.48 units on a scaleStandard Deviation 0.99
Assigned Intervention, no ExposuresFrequency of Teen Alcohol Use Over Most Recent 30 Days Within Past 6 Months6 month follow-up.43 units on a scaleStandard Deviation 0.95
Assigned Intervention, no ExposuresFrequency of Teen Alcohol Use Over Most Recent 30 Days Within Past 6 Months18 month follow-up.29 units on a scaleStandard Deviation 0.64
Control ConditionFrequency of Teen Alcohol Use Over Most Recent 30 Days Within Past 6 Months6 month follow-up.21 units on a scaleStandard Deviation 0.62
Control ConditionFrequency of Teen Alcohol Use Over Most Recent 30 Days Within Past 6 Months18 month follow-up.43 units on a scaleStandard Deviation 0.93
Control ConditionFrequency of Teen Alcohol Use Over Most Recent 30 Days Within Past 6 Months12 month follow-up.30 units on a scaleStandard Deviation 0.82
Comparison: 6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.p-value: <0.001Regression, Linear
Comparison: 12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.p-value: <0.01Regression, Linear
Comparison: 18 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. All controls were assigned 0 dosage.p-value: >0.1ANOVA
Primary

Frequency of Teen-parent Communications About Specific Sexual Topics

Average frequency created across 4 different sex topics (i. how being in a relationship might divert me from achieving my goals at school, ii. how embarrassing it would be if I caught an STI -sexually transmitted infection, iii. sexual relationships can impact health, iv. how pregnancy would be embarassing) with responses being never=1, occasionally=2, sometimes=3, often=4, very often=5 for a full range of 1-5. Across the 4 different sex topics the sums ranged from 4-20 and average was created by dividing the score by 4, with higher scores indicating more both topics and higher frequency of discussions taking place for a final full range of 1-5.

Time frame: Measured at baseline, 6, 12, & 18 months

Population: The number analyzed varies across rows because the rows represent different follow-up periods and participation varied across follow-ups.

ArmMeasureGroupValue (MEAN)Dispersion
Smart Choices 4 TeensFrequency of Teen-parent Communications About Specific Sexual TopicsFrequency of sexual communication at 12 month follow-up2.50 score on a scaleStandard Deviation 1.12
Smart Choices 4 TeensFrequency of Teen-parent Communications About Specific Sexual TopicsFrequency of sexual communication at 6 month follow-up2.60 score on a scaleStandard Deviation 1.11
Smart Choices 4 TeensFrequency of Teen-parent Communications About Specific Sexual TopicsFrequency of sexual communication at 18 month follow-up2.47 score on a scaleStandard Deviation 1.1
Assigned Intervention, no ExposuresFrequency of Teen-parent Communications About Specific Sexual TopicsFrequency of sexual communication at 12 month follow-up2.03 score on a scaleStandard Deviation 0.93
Assigned Intervention, no ExposuresFrequency of Teen-parent Communications About Specific Sexual TopicsFrequency of sexual communication at 6 month follow-up2.23 score on a scaleStandard Deviation 1.06
Assigned Intervention, no ExposuresFrequency of Teen-parent Communications About Specific Sexual TopicsFrequency of sexual communication at 18 month follow-up2.50 score on a scaleStandard Deviation 1.12
Control ConditionFrequency of Teen-parent Communications About Specific Sexual TopicsFrequency of sexual communication at 6 month follow-up2.27 score on a scaleStandard Deviation 1.1
Control ConditionFrequency of Teen-parent Communications About Specific Sexual TopicsFrequency of sexual communication at 18 month follow-up2.23 score on a scaleStandard Deviation 1.06
Control ConditionFrequency of Teen-parent Communications About Specific Sexual TopicsFrequency of sexual communication at 12 month follow-up2.36 score on a scaleStandard Deviation 1.11
Comparison: Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.p-value: <0.03generalized estimating equations
Primary

Frequency of Teen- Parent Communications Regarding Sex

Overall, how often you have talked to your parent about sex? (1=Never, 2=Occasionally, 3=Sometimes, 4=Often, 5= Very often). Range 1-5. Higher scores represent a better outcome.

Time frame: Measured at baseline, 6, 12, & 18 months

Population: The rows represent 3 different follow-up periods and the number of cases analyzed varied because the responses at follow-up varied.

ArmMeasureGroupValue (MEAN)Dispersion
Smart Choices 4 TeensFrequency of Teen- Parent Communications Regarding Sex18 month follow-up2.46 score on a scaleStandard Deviation 1.17
Smart Choices 4 TeensFrequency of Teen- Parent Communications Regarding Sex6 month follow2.46 score on a scaleStandard Deviation 0.99
Smart Choices 4 TeensFrequency of Teen- Parent Communications Regarding Sex12 month follow up2.45 score on a scaleStandard Deviation 1.17
Assigned Intervention, no ExposuresFrequency of Teen- Parent Communications Regarding Sex18 month follow-up1.97 score on a scaleStandard Deviation 1.08
Assigned Intervention, no ExposuresFrequency of Teen- Parent Communications Regarding Sex6 month follow2.18 score on a scaleStandard Deviation 1.28
Assigned Intervention, no ExposuresFrequency of Teen- Parent Communications Regarding Sex12 month follow up2.02 score on a scaleStandard Deviation 1.09
Control ConditionFrequency of Teen- Parent Communications Regarding Sex18 month follow-up2.07 score on a scaleStandard Deviation 1.04
Control ConditionFrequency of Teen- Parent Communications Regarding Sex6 month follow2.19 score on a scaleStandard Deviation 1.2
Control ConditionFrequency of Teen- Parent Communications Regarding Sex12 month follow up2.23 score on a scaleStandard Deviation 1.16
Comparison: Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.p-value: <0.01generalized estimating equations
Primary

Number of Teens Using Any Alcohol During Past 6 Months

Have you had a drink of alcohol in the past 6 months? (A drink is a glass of wine, a can of beer, a wine cooler, a shot glass of liquor, or a mixed drink). (Response category yes=1/no=0). Range is 0-1. More frequent drinking is a worse outcome.

Time frame: Measured at baseline, 6, 12, & 18 months

Population: Some teens were lost at follow-up

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Smart Choices 4 TeensNumber of Teens Using Any Alcohol During Past 6 Monthsat 12 month follow-up14 Participants
Smart Choices 4 TeensNumber of Teens Using Any Alcohol During Past 6 Monthsat 6 month follow-up16 Participants
Smart Choices 4 TeensNumber of Teens Using Any Alcohol During Past 6 Monthsat 18 month follow-up26 Participants
Assigned Intervention, no ExposuresNumber of Teens Using Any Alcohol During Past 6 Monthsat 12 month follow-up23 Participants
Assigned Intervention, no ExposuresNumber of Teens Using Any Alcohol During Past 6 Monthsat 6 month follow-up20 Participants
Assigned Intervention, no ExposuresNumber of Teens Using Any Alcohol During Past 6 Monthsat 18 month follow-up24 Participants
Control ConditionNumber of Teens Using Any Alcohol During Past 6 Monthsat 6 month follow-up38 Participants
Control ConditionNumber of Teens Using Any Alcohol During Past 6 Monthsat 18 month follow-up47 Participants
Control ConditionNumber of Teens Using Any Alcohol During Past 6 Monthsat 12 month follow-up43 Participants
Comparison: 6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.p-value: <0.01Regression, Logistic
Comparison: 12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.p-value: <0.1Regression, Logistic
Comparison: 18 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. All controls were assigned 0 dosage.p-value: 0.077Chi-squared
Primary

Quantity of Alcohol Consumed by Teens on Drinking Days for the Most Recent 30 Days Within the Past Six Months

Over the past 30 days, how many drinks did you usually have on days you drank? (response categories: 0= less than one, 1, 2, 3, 4, 5, 6, 7= more than six). Range is 0-7. Higher scores represent more drinking and worse outcome.

Time frame: Measured at baseline, 6, 12, & 18 months

Population: Cases lost to follow-up and for missing data.

ArmMeasureGroupValue (MEAN)Dispersion
Smart Choices 4 TeensQuantity of Alcohol Consumed by Teens on Drinking Days for the Most Recent 30 Days Within the Past Six Months12 month follow-up.13 units on a scaleStandard Deviation 0.64
Smart Choices 4 TeensQuantity of Alcohol Consumed by Teens on Drinking Days for the Most Recent 30 Days Within the Past Six Months6 month follow-up.16 units on a scaleStandard Deviation 0.64
Smart Choices 4 TeensQuantity of Alcohol Consumed by Teens on Drinking Days for the Most Recent 30 Days Within the Past Six Months18 month follow-up.46 units on a scaleStandard Deviation 1.18
Assigned Intervention, no ExposuresQuantity of Alcohol Consumed by Teens on Drinking Days for the Most Recent 30 Days Within the Past Six Months12 month follow-up.61 units on a scaleStandard Deviation 1.28
Assigned Intervention, no ExposuresQuantity of Alcohol Consumed by Teens on Drinking Days for the Most Recent 30 Days Within the Past Six Months6 month follow-up.46 units on a scaleStandard Deviation 1.22
Assigned Intervention, no ExposuresQuantity of Alcohol Consumed by Teens on Drinking Days for the Most Recent 30 Days Within the Past Six Months18 month follow-up.45 units on a scaleStandard Deviation 1.26
Control ConditionQuantity of Alcohol Consumed by Teens on Drinking Days for the Most Recent 30 Days Within the Past Six Months6 month follow-up.32 units on a scaleStandard Deviation 1.13
Control ConditionQuantity of Alcohol Consumed by Teens on Drinking Days for the Most Recent 30 Days Within the Past Six Months18 month follow-up.60 units on a scaleStandard Deviation 1.48
Control ConditionQuantity of Alcohol Consumed by Teens on Drinking Days for the Most Recent 30 Days Within the Past Six Months12 month follow-up.40 units on a scaleStandard Deviation 1.13
Comparison: 6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.p-value: <0.1Regression, Linear
Comparison: 12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.p-value: <0.05Regression, Linear
Comparison: 18 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. All controls were assigned 0 dosage.p-value: >0.1ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026