An interventional study of Smart Choices 4 Teens in Alcohol Drinking, Alcohol Intoxication and Alcohol Poison, sponsored by Pacific Institute for Research and Evaluation. Completed at 1 site in United States. Open to participants aged 16 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by Pacific Institute for Research and Evaluation · Not applicable, Interventional, and Prevention
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.
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.
701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.
This study's enrollment of 411 is above the median of 122 across 607 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →Pacific Institute for Research and Evaluation is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Compared within Alcohol Drinking, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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. Numbers are provided for the number of families
Behavioral: Smart Choices 4 Teens
This group was provided with websites where information was available regarding the same topics.
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.
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
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
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
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
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
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
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
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
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
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
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
November 2014-November 2015 Recruited national sample from two panel vendors
| Milestone | Smart Choices 4 Teens | Control Condition |
|---|---|---|
| Started | 206 | 205 |
| Completed | 206 | 205 |
| Not completed | 0 | 0 |
| Milestone | Smart Choices 4 Teens | Control Condition |
|---|---|---|
| Started | 206 | 205 |
| Completed | 150 | 165 |
| Not completed | 56 | 40 |
| Withdrew: Lost to follow-up | 56 | 40 |
| Milestone | Smart Choices 4 Teens | Control Condition |
|---|---|---|
| Started | 150 | 165 |
| Completed | 147 | 164 |
| Not completed | 3 | 1 |
| Withdrew: Lost to follow-up | 3 | 1 |
| Milestone | Smart Choices 4 Teens | Control Condition |
|---|---|---|
| Started | 147 | 164 |
| Completed | 145 | 164 |
| Not completed | 2 | 0 |
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.
| Participants | Smart Choices 4 Teens | Assigned Intervention, no Exposures | Control Condition |
|---|---|---|---|
| at 6 month follow-up | 16 | 20 | 38 |
| at 12 month follow-up | 14 | 23 | 43 |
| at 18 month follow-up | 26 | 24 | 47 |
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.
| units on a scale | Smart Choices 4 Teens | Assigned Experimental, No Exposure | Control Condition |
|---|---|---|---|
| 6 month follow-up | .16 ± .56 | .43 ± .95 | .21 ± .62 |
| 12 month follow-up | .09 ± .36 | .48 ± .99 | .30 ± .82 |
| 18 month follow-up | .31 ± .69 | .29 ± .64 | .43 ± .93 |
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.
| units on a scale | Smart Choices 4 Teens | Assigned Experimental, No Exposure | Control Condition |
|---|---|---|---|
| 6 month follow-up | .16 ± .64 | .46 ± 1.22 | .32 ± 1.13 |
| 12 month follow-up | .13 ± .64 | .61 ± 1.28 | .40 ± 1.13 |
| 18 month follow-up | .46 ± 1.18 | .45 ± 1.26 | .60 ± 1.48 |
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.
| score on a scale | Smart Choices 4 Teens | Assigned Experimental, no Exposure | Control Condition |
|---|---|---|---|
| 6 month follow-up | .10 ± .40 | .26 ± .96 | .23 ± .91 |
| 12 month follow-up | .08 ± .35 | .44 ± 1.46 | .39 ± 1.20 |
| 18 month follow-up | .21 ± .61 | .26 ± 1.00 | .45 ± 1.30 |
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.
| units on a scale | Smart Choices 4 Teens | Assigned Intervention, no Exposures | Control Condition |
|---|---|---|---|
| 6 month follow-up | 1.99 ± 1.31 | 2.59 ± 1.40 | 2.26 ± 1.35 |
| 12 month follow-up | 2.16 ± 1.29 | 2.66 ± 1.55 | 2.19 ± 1.27 |
| 18 month follow-up | 2.12 ± 1.40 | 2.57 ± 1.31 | 2.13 ± 1.28 |
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.
| score on a scale | Smart Choices 4 Teens | Assigned Intervention, no Exposure | Control Condition |
|---|---|---|---|
| 6 month follow | 2.46 ± 0.99 | 2.18 ± 1.28 | 2.19 ± 1.20 |
| 12 month follow up | 2.45 ± 1.17 | 2.02 ± 1.09 | 2.23 ± 1.16 |
| 18 month follow-up | 2.46 ± 1.17 | 1.97 ± 1.08 | 2.07 ± 1.04 |
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.
| score on a scale | Smart Choices 4 Teens | Assigned Intervention, no Exposure | Control Condition |
|---|---|---|---|
| Frequency of sexual communication at 6 month follow-up | 2.60 ± 1.11 | 2.23 ± 1.06 | 2.27 ± 1.10 |
| Frequency of sexual communication at 12 month follow-up | 2.50 ± 1.12 | 2.03 ± 0.93 | 2.36 ± 1.11 |
| Frequency of sexual communication at 18 month follow-up | 2.47 ± 1.10 | 2.50 ± 1.12 | 2.23 ± 1.06 |
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.
| score on a scale | Smart Choices 4 Teens | Assigned Intervention, no Exposure | Control Condition |
|---|---|---|---|
| Communication regarding delay sex at 6 month follow-up | 1.13 ± 1.09 | 0.85 ± 0.98 | 0.98 ± 1.04 |
| Communication regarding delay sex at 12 month follow-up | 1.09 ± 1.11 | 1.02 ± 1.08 | 1.07 ± 1.10 |
| Communication regarding delay sex at 18 month follow-up | 0.98 ± 1.04 | 0.75 ± 1.00 | 0.95 ± 1.11 |
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.
| score on a scale | Smart Choices 4 Teens | Assigned Intervention, no Exposure | Control Condition |
|---|---|---|---|
| Communications on Health Risks at 6 month follow-up | 1.63 ± 0.71 | 1.35 ± 0.89 | 1.51 ± .77 |
| Communications on Health Risks at 12 month Follow-up | 1.53 ± 0.77 | 1.40 ± 0.86 | 1.54 ± 0.79 |
| Communications on Health Risk at 18 month follow-up | 1.49 ± 0.83 | 1.27 ± 0.90 | 1.38 ± 0.86 |
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.
| score on a scale | Smart Choices 4 Teens | Assigned Intervention, no Exposure | Control Condition |
|---|---|---|---|
| Dating Rules-Teen report 6 month follow-up | 11.48 ± 2.97 | 10.18 ± 3.91 | 10.77 ± 3.57 |
| Dating rules, teen report, 12 month follow-up | 11.04 ± 3.47 | 10.42 ± 3.57 | 10.72 ± 3.44 |
| Dating rules, teen report, 18 month follow-up | 11.01 ± 3.29 | 9.53 ± 3.59 | 10.08 ± 4.09 |
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.
| Participants | Smart Choices 4 Teens | Assigned Intervention, no Exposure | Control Condition |
|---|---|---|---|
| ever had sex at 6 month follow-up | 17 | 15 | 37 |
| ever had sex at 12 month follow-up | 17 | 20 | 39 |
| ever had sex at 18 month follow-up | 19 | 21 | 46 |
Collected over Over three years of the study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Smart Choices 4 Teens | 0/206 (0%) | 0/206 (0%) | 0/206 (0%) |
| Control Condition | 0/205 (0%) | 0/205 (0%) | 0/205 (0%) |
| Age, Continuous(years) | Smart Choices 4 Teens | Control Condition | Total |
|---|---|---|---|
| parent age | 43.73 ± 7.039 | 43.75 ± 6.385 | 43.74 ± 6.711 |
| teen age | 16.40 ± .492 | 16.34 ± .474 | 16.37 ± .483 |
| Sex: Female, Male(Participants) | Smart Choices 4 Teens | Control Condition | Total |
|---|---|---|---|
| Parent Gender — Female | 173 | 175 | 348 |
| Parent Gender — Male | 33 | 30 | 63 |
| Teen Gender — Female | 109 | 117 | 226 |
| Teen Gender — Male | 96 | 87 | 183 |
| Ethnicity (NIH/OMB)(Participants) | Smart Choices 4 Teens | Control Condition | Total |
|---|---|---|---|
| Parent Ethnicity — Hispanic or Latino | 16 | 14 | 30 |
| Parent Ethnicity — Not Hispanic or Latino | 190 | 190 | 380 |
| Parent Ethnicity — Unknown or Not Reported | 0 | 1 | 1 |
| Teen Ethnicity — Hispanic or Latino | 21 | 14 | 35 |
| Teen Ethnicity — Not Hispanic or Latino | 179 | 190 | 369 |
| Teen Ethnicity — Unknown or Not Reported | 6 | 1 | 7 |
| Race (NIH/OMB)(Participants) | Smart Choices 4 Teens | Control Condition | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 1 | 3 |
| Asian | 4 | 4 | 8 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 24 | 24 | 48 |
| White | 161 | 157 | 318 |
| More than one race | 13 | 11 | 24 |
| Unknown or Not Reported | 2 | 7 | 9 |
| Region of Enrollment(participants) | Smart Choices 4 Teens | Control Condition | Total |
|---|---|---|---|
| United States | 206 | 205 | 411 |
| Any Alcohol Use(Participants) | Smart Choices 4 Teens | Control Condition | Total |
|---|---|---|---|
| Count of participants | 21 | 26 | 47 |
| Frequency of Alcohol Use(units on a scale) | Smart Choices 4 Teens | Control Condition | Total |
|---|---|---|---|
| Mean | .21 ± .59 | .17 ± .54 | .19 ± .57 |
| Quantity of alcohol consumed on drinking days(units on a scale) | Smart Choices 4 Teens | Control Condition | Total |
|---|---|---|---|
| Mean | .27 ± .93 | .26 ± 1.05 | .27 ± .99 |
8 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2013 to primary completion in May 2017, 49 months.
Results were first posted in Oct 2021, 4 years 4 months after primary completion.
Of 328 non-industry interventional studies with no phase under Alcohol Drinking, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 49 months is above that.
Counting every sponsor, half of 336 studies reached it within 24 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Pacific Institute for Research and Evaluation