An interventional study of REAL Parenting and Active Control Materials in Underage Drinking and Alcohol Use, Underage, sponsored by Real Prevention, LLC. Completed at 1 site in United States. Open to participants aged 15 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Real Prevention, LLC · Not applicable, Interventional, and Prevention
High school students' alcohol, nicotine, and marijuana use are major public health problems. Among the many consequences of these risky behaviors are impaired driving and impaired passenger fatalities as well as increased health risks. Both school administrators and parents have requested parent-based interventions (PBIs)for the general high school population that include content on alcohol, nicotine and marijuana use. In addition, digital materials are needed for the "on-the-go" parent. The proposed research will address this omission, curb the alarming trends noted above, and move the field forward by conducting a randomized controlled trial testing a modified, digital version of the Parent Handbook for the all high school students that includes additional content for parents to have broader discussions about combined alcohol nicotine and marijuana use alone (referred to as REAL Parenting). Parent-teen dyads will be invited to participate and complete baseline assessment and parents will receive the REAL Parenting or active control materials shortly afterwards. This will allow an examination of the impact of the RP on alcohol use, and associated consequences and sustained effects across the follow-up period.
The goal of this Phase II SBIR is to provide an efficient, engaging, and effective means to enhance parents' ability to reduce prevalence of alcohol use and consequences, and other substance use through the development and evaluation of REAL Parenting (RP). RP is a brief, interactive, self-paced, and digital curriculum for parents of high-school-aged adolescents, a frequently neglected population created from the evidence-based Parent Handbook,available in hard copy and DVD for college-bound youth only. The curriculum is needed because most parent-based prevention interventions target children or young adolescents, neglecting older adolescents, despite that fact that alcohol use increases in frequency and risk through midadolescence. Also, unlike other evidence-based parenting curricula, RP is brief, requires only the parents, does not require training, and can be used "on the go" through any digital device. This provides a market niche for the proposed project that addresses this curriculum gap through the innovative use of both technology and prevention science. This format will allow us to personalize or target parents based on their communication style and allows parents to customize their experience by choosing or clicking through the optional content. Personalization and customization are two essential engagement strategies for digital prevention interventions.
44 studies on the registry are indexed under Underage Drinking; 13 are open to participants now.
This study's enrollment of 612 is above the median of 360 across 43 interventional studies indexed under Underage Drinking.
Browse Underage Drinking studies →Real Prevention, LLC is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria:
REAL Parenting digital intervention emphasizing parent-teen/young adult communication on drinking/risks of drinking/risks of alcohol abuse, with the addition of a communication component on the risks of nicotine and marijuana use, with the goal of reducing alcohol, nicotine and marijuana use in college students.
Behavioral: REAL Parenting
NIAAA materials on underage drinking for parents
Other: Active Control Materials
REAL Parenting digital intervention emphasizing parent-teen/young adult communication on drinking/risks of drinking/risks of alcohol abuse, with the addition of a communication component on the risks of nicotine and marijuana use, with the goal of reducing alcohol, nicotine and marijuana use in college students.
NIAAA materials on underage drinking for parents
Frequency Past 3-month Drinking
Teens were asked, "During the past 3 months, on how many days did you have at least one drink of alcohol?". Response options ranged from 0 to 6 where, 0=0 days, 1=1 or 2 days, 2=3 to 5 days, 3=6 to 9 days, 4=10 to 19 days 5=20 to 29 days, and 6=30 days or more. Higher scores indicated the participant consumed alcohol more frequently in the past 3 months. Higher scores indicate a worse outcome and lower scores indicate a better outcome.
Time frame: T5 (12-months post baseline)
Frequency of Past 3-month Marijuana Use
Teens were asked, "During the past 3 months, how many times did you use marijuana?". Response options were on a 6-point scale ranging from 0 to 5, where 0=0 times, 1=1 or 2 times, 2=3 to 9 times, 3=10 to 19 times, 4=20 to 39 times, and 5=40 or more times. Higher scores indicated the participant used marijuana more frequently in the past 3 months. Higher scores indicate a worse outcome and lower scores indicate a better outcome.
Time frame: T5 (12-months post-baseline)
Combined Use of Alcohol and Marijuana
Teens were asked, "During the past 3 months, how many of the times when you used marijuana did you use it at the same time as alcohol - that is, so that their effects overlapped?". Response options were on a 6-point scale ranging from 0 to 5 where 0=0 times, 1=1 or 2 times, 2=3 to 9 times, 3=10 to 19 times, 4=20 to 39 times, and 5=40 or more times. Higher scores indicated the participant combined alcohol and marijuana more frequently in the past 3 months. Higher scores indicate a worse outcome and lower scores indicate a better outcome.
Time frame: T5 (12-months post-baseline)
Consequences of Alcohol Use
Alcohol-related consequences (e.g., have a hangover, do poorly on schoolwork) were adapted using the established Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ; Read, Kahler, Strong, \& Colder, 2006). Teens responded to 10-items asking them, "During the past 3 months, how many times did you \[insert consequence item here\]". Response options were on a 5-point scale ranging from 0 to 4 where 0=0 times, 1=1 time, 2=2 times, 3=3 times, and 4=4 or more times. Responses were summed with higher scores indicating the participant experienced more alcohol-related consequences in the past 3-months (range=0-40). Higher scores indicate a worse outcome and lower scores indicate a better outcome.
Time frame: T5 (12-months post-baseline)
Frequency of Past 3-month Nicotine Use
Teens were asked, "During the past 3 months, on how many days did you use an electronic vapor product?". Response options were on a 7-point scale ranging from 0 to 6 where 0=0 days, 1=1 or 2 days, 2=3 to 5 days, 3=6 to 9 days, 4=10 to 19 days, and 5=20 to 29 days, 6=30 days or more. Higher scores indicated the participant used an electronic vapor product more frequently in the past 3 months. Higher scores indicate a worse outcome and lower scores indicate a better outcome.
Time frame: T5 (12-months post-baseline)
Alcohol Motives
Teens were asked to respond to 12 items, "In the past 3 months, how often did you \[insert item\]?". Sample items include, "because it's fun", "to be liked", "so you won't feel left out". Response options were on a 3-point scale ranging from 0 to 2 where 0=Never, 1=Sometimes, and 3=Almost always. Responses from the 12 items were averaged with higher scores indicating the participant had higher motives to consume alcohol (range=0-3). Higher scores indicate a worse outcome and lower scores indicate a better outcome.
Time frame: T2 (3-months post-baseline)
Alcohol Expectancies
Teens were asked, "Please respond to the following items by selecting the response that corresponds with how much you agree or disagree with the statement.". The 5 items included on this scale included things like, "drinking makes people feel good" and "drinking is an acceptable way to cope with problems". Response options were on a 5-point scale ranging from 0 to 4 where 0=Strongly disagree, 1=Disagree, 2=Neither agree nor disagree, 3=Agree, and 4=Strongly agree. The 5 items were averaged with higher scores indicating the participant had more positive alcohol expectancies (range=0-5). Higher scores indicate a worse outcome and lower scores indicate a better outcome.
Time frame: T2 (3-months post-baseline)
Alcohol Willingness
Teens were asked, "Please indicate the amount you agree with the following statements.". The 5 items included statements like, "I am willing to drink alcohol on weekend evenings" and "I am willing to drive a car when I have consumed alcohol". Responses options were on a 5-point scale ranging from 0 to 4 where 0=Strongly disagree, 1=Disagree, 2=Neither agree nor disagree, 3=Agree, and 4=Strongly agree". The 5 items were averaged with higher scores indicating the participant was more willing to drink alcohol and engage in risky behaviors while consuming alcohol (range=0-4). Higher scores indicate a worse outcome and lower scores indicate a better outcome.
Time frame: T2 (3-months post-baseline)
Alcohol Injunctive Norms
Teens were asked, "How acceptable do you think your close friends find each of the following behaviors?". The 5 items included things like, "Drinking alcohol once in a while" and "Drinking alcohol on special occasions". Response options were on a 5-point scale ranging from 0 to 4 where 0=very unacceptable, 1=unacceptable, 0=neither acceptable nor unacceptable, 3=acceptable, and 4=very acceptable. The 5 items were averaged with higher scores indicating the participant had more positive injunctive norms about alcohol (range=0-5). Higher scores indicate a worse outcome and lower scores indicate a better outcome.
Time frame: T2 (3-months post-baseline)
Parental Alcohol Communication
Teens were asked, "The next set of items asks specifically about communication with your \[mother/father\]. Please indicate if your \[mother/father\] has spoken to you about the following topics in the past 3 months.". The 19 items included things like, "Alternative options to drinking", "Whether I drink alcohol", and "How even small amounts of alcohol can effect my brain". Response options were on a 4-point scale ranging from 0 to 4 where 0=not at all, 1=very little, 2=somewhat, and 3=a great deal. The 19 items were averaged with higher scores indicating the participants parent communicated with them about various alcohol topics more frequently (range=0-3). Higher scores indicate a better outcome and lower scores indicate a worse outcome.
Time frame: T2 (3-months post-baseline)
Parent-teen dyads were recruited from a nationally representative probability-based web panel (KnowledgePanel) maintained by the consumer information company Ipsos during January of 2021. Ipsos randomly sampled households with at least one parent or legal guardian to at least one 15-18-year-old. Selected parents who met this eligibility criteria were invited to participate in the study via email.
| Milestone | REAL Parenting | Active Control Materials |
|---|---|---|
| Started | 320 | 292 |
| T2 parent survey (3-months post-baseline) | 126 | 122 |
| T2 teen survey (3-months post-baseline) | 126 | 122 |
| T3 (6-months post-baseline) | 124 | 115 |
| T4 (9-months post-baseline) | 132 | 106 |
| T5 (12-months post-baseline) | 127 | 103 |
| Completed | 254 | 206 |
| Not completed | 66 | 86 |
Teens were asked, "During the past 3 months, on how many days did you have at least one drink of alcohol?". Response options ranged from 0 to 6 where, 0=0 days, 1=1 or 2 days, 2=3 to 5 days, 3=6 to 9 days, 4=10 to 19 days 5=20 to 29 days, and 6=30 days or more. Higher scores indicated the participant consumed alcohol more frequently in the past 3 months. Higher scores indicate a worse outcome and lower scores indicate a better outcome.
| units on a scale | REAL Parenting | Active Control Materials |
|---|---|---|
| Frequency Past 3-month Drinking | 0.50 ± 0.09 | 0.45 ± 0.10 |
Teens were asked, "During the past 3 months, how many times did you use marijuana?". Response options were on a 6-point scale ranging from 0 to 5, where 0=0 times, 1=1 or 2 times, 2=3 to 9 times, 3=10 to 19 times, 4=20 to 39 times, and 5=40 or more times. Higher scores indicated the participant used marijuana more frequently in the past 3 months. Higher scores indicate a worse outcome and lower scores indicate a better outcome.
| units on a scale | REAL Parenting | Active Control Materials |
|---|---|---|
| Frequency of Past 3-month Marijuana Use | 0.29 ± 0.07 | 0.42 ± 0.08 |
Teens were asked, "During the past 3 months, how many of the times when you used marijuana did you use it at the same time as alcohol - that is, so that their effects overlapped?". Response options were on a 6-point scale ranging from 0 to 5 where 0=0 times, 1=1 or 2 times, 2=3 to 9 times, 3=10 to 19 times, 4=20 to 39 times, and 5=40 or more times. Higher scores indicated the participant combined alcohol and marijuana more frequently in the past 3 months. Higher scores indicate a worse outcome and lower scores indicate a better outcome.
| units on a scale | REAL Parenting | Active Control Materials |
|---|---|---|
| Combined Use of Alcohol and Marijuana | 1.18 ± 0.36 | 0.96 ± 0.63 |
Alcohol-related consequences (e.g., have a hangover, do poorly on schoolwork) were adapted using the established Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ; Read, Kahler, Strong, \& Colder, 2006). Teens responded to 10-items asking them, "During the past 3 months, how many times did you \[insert consequence item here\]". Response options were on a 5-point scale ranging from 0 to 4 where 0=0 times, 1=1 time, 2=2 times, 3=3 times, and 4=4 or more times. Responses were summed with higher scores indicating the participant experienced more alcohol-related consequences in the past 3-months (range=0-40). Higher scores indicate a worse outcome and lower scores indicate a better outcome.
| score on a scale | REAL Parenting | Active Control Materials |
|---|---|---|
| Consequences of Alcohol Use | 0.82 ± 0.31 | 0.83 ± 0.35 |
Teens were asked, "During the past 3 months, on how many days did you use an electronic vapor product?". Response options were on a 7-point scale ranging from 0 to 6 where 0=0 days, 1=1 or 2 days, 2=3 to 5 days, 3=6 to 9 days, 4=10 to 19 days, and 5=20 to 29 days, 6=30 days or more. Higher scores indicated the participant used an electronic vapor product more frequently in the past 3 months. Higher scores indicate a worse outcome and lower scores indicate a better outcome.
| units on a scale | REAL Parenting | Active Control Materials |
|---|---|---|
| Frequency of Past 3-month Nicotine Use | 0.33 ± 0.10 | 0.36 ± 0.11 |
Teens were asked to respond to 12 items, "In the past 3 months, how often did you \[insert item\]?". Sample items include, "because it's fun", "to be liked", "so you won't feel left out". Response options were on a 3-point scale ranging from 0 to 2 where 0=Never, 1=Sometimes, and 3=Almost always. Responses from the 12 items were averaged with higher scores indicating the participant had higher motives to consume alcohol (range=0-3). Higher scores indicate a worse outcome and lower scores indicate a better outcome.
| units on a scale | REAL Parenting | Active Control Materials |
|---|---|---|
| Alcohol Motives | 0.09 ± 0.02 | 0.07 ± 0.02 |
Teens were asked, "Please respond to the following items by selecting the response that corresponds with how much you agree or disagree with the statement.". The 5 items included on this scale included things like, "drinking makes people feel good" and "drinking is an acceptable way to cope with problems". Response options were on a 5-point scale ranging from 0 to 4 where 0=Strongly disagree, 1=Disagree, 2=Neither agree nor disagree, 3=Agree, and 4=Strongly agree. The 5 items were averaged with higher scores indicating the participant had more positive alcohol expectancies (range=0-5). Higher scores indicate a worse outcome and lower scores indicate a better outcome.
| units on a scale | REAL Parenting | Active Control Materials |
|---|---|---|
| Alcohol Expectancies | 1.20 ± 0.06 | 1.13 ± 0.07 |
Teens were asked, "Please indicate the amount you agree with the following statements.". The 5 items included statements like, "I am willing to drink alcohol on weekend evenings" and "I am willing to drive a car when I have consumed alcohol". Responses options were on a 5-point scale ranging from 0 to 4 where 0=Strongly disagree, 1=Disagree, 2=Neither agree nor disagree, 3=Agree, and 4=Strongly agree". The 5 items were averaged with higher scores indicating the participant was more willing to drink alcohol and engage in risky behaviors while consuming alcohol (range=0-4). Higher scores indicate a worse outcome and lower scores indicate a better outcome.
| units on a scale | REAL Parenting | Active Control Materials |
|---|---|---|
| Alcohol Willingness | 0.84 ± 0.05 | 0.2 ± 0.05 |
Teens were asked, "How acceptable do you think your close friends find each of the following behaviors?". The 5 items included things like, "Drinking alcohol once in a while" and "Drinking alcohol on special occasions". Response options were on a 5-point scale ranging from 0 to 4 where 0=very unacceptable, 1=unacceptable, 0=neither acceptable nor unacceptable, 3=acceptable, and 4=very acceptable. The 5 items were averaged with higher scores indicating the participant had more positive injunctive norms about alcohol (range=0-5). Higher scores indicate a worse outcome and lower scores indicate a better outcome.
| units on a scale | REAL Parenting | Active Control Materials |
|---|---|---|
| Alcohol Injunctive Norms | 1.33 ± 0.07 | 1.09 ± 0.07 |
Teens were asked, "The next set of items asks specifically about communication with your \[mother/father\]. Please indicate if your \[mother/father\] has spoken to you about the following topics in the past 3 months.". The 19 items included things like, "Alternative options to drinking", "Whether I drink alcohol", and "How even small amounts of alcohol can effect my brain". Response options were on a 4-point scale ranging from 0 to 4 where 0=not at all, 1=very little, 2=somewhat, and 3=a great deal. The 19 items were averaged with higher scores indicating the participants parent communicated with them about various alcohol topics more frequently (range=0-3). Higher scores indicate a better outcome and lower scores indicate a worse outcome.
| units on a scale | REAL Parenting | Active Control Materials |
|---|---|---|
| Parental Alcohol Communication | 1.73 ± 0.07 | 1.50 ± 0.07 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| REAL Parenting | 0/320 (0%) | 0/320 (0%) | 0/320 (0%) |
| Active Control Materials | 0/292 (0%) | 0/292 (0%) | 0/292 (0%) |
The overall number of baseline participants includes both parents and their teens. REAL Parenting includes 320 parents and teens (160 parent-teen dyads) and Active Control includes 292 participants (146 parent-teen dyads).
| Age, Continuous(years) | REAL Parenting | Active Control Materials | Total |
|---|---|---|---|
| Parents | 45.64 ± 7.18 | 46.35 ± 6.62 | 45.96 ± 6.91 |
| Teens | 16.31 ± 0.95 | 16.42 ± 0.79 | 16.36 ± 0.92 |
| Sex/Gender, Customized(Participants) | REAL Parenting | Active Control Materials | Total |
|---|---|---|---|
| Teens — Male | 75 | 64 | 139 |
| Teens — Female | 81 | 78 | 159 |
| Teens — Transgender man/trans man/female-to-male (FTM) | 0 | 1 | 1 |
| Teens — Transgender woman/trans woman/male0to-female (MTF) | 1 | 0 | 1 |
| Teens — Genderqueer/gender nonconforming neither exclusively male nor female | 2 | 2 | 4 |
| Teens — Decline to answer | 1 | 1 | 2 |
| Sex: Female, Male(Participants) | REAL Parenting | Active Control Materials | Total |
|---|---|---|---|
| Parents — Female | 98 | 81 | 179 |
| Parents — Male | 62 | 65 | 127 |
| Ethnicity (NIH/OMB)(Participants) | REAL Parenting | Active Control Materials | Total |
|---|---|---|---|
| Hispanic or Latino | 41 | 34 | 75 |
| Not Hispanic or Latino | 117 | 112 | 229 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Race (NIH/OMB)(Participants) | REAL Parenting | Active Control Materials | Total |
|---|---|---|---|
| American Indian or Alaska Native | 3 | 3 | 6 |
| Asian | 9 | 9 | 18 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 24 | 11 | 35 |
| White | 112 | 111 | 223 |
| More than one race | 10 | 11 | 21 |
| Unknown or Not Reported | 2 | 1 | 3 |
| Race/Ethnicity, Customized(Participants) | REAL Parenting | Active Control Materials | Total |
|---|---|---|---|
| Parents — White, Non-Hispanic | 90 | 97 | 187 |
| Parents — Black, Non-Hispanic | 26 | 13 | 39 |
| Parents — Other, Non-Hispanic | 10 | 10 | 20 |
| Parents — Hispanic | 30 | 21 | 51 |
| Parents — 2+ Races, Non-Hispanic | 4 | 5 | 9 |
| Frequency past 3-month drinking(units on a scale) | REAL Parenting | Active Control Materials | Total |
|---|---|---|---|
| Mean | 0.32 ± 0.77 | 0.29 ± 0.80 | 0.31 ± 0.78 |
PDFs hosted by the registry, ClinicalTrials.gov.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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