Underage DrinkingRPNCT03932097
REAL Parenting Alcohol and Substance Use App
A study testing REAL Parenting in people with Underage Drinking and Alcohol Use, Underage, run by Real Prevention, LLC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Underage Drinking, Alcohol Use, Underage
- What is being tested?
- REAL Parenting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2021to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- High school students (ages 15-18) who may be at risk for alcohol, marijuana and nicotine use and abuse, and whose parent/guardian is willing to participate in the proposed study as part of a parent/student dyad.
- High school students ages 15-18 with their parents/guardians; English fluency; Internet access; at least one parent/guardian fluent in English and with Internet access
Who cannot join
- Not high school aged (not ages 15-18)
- Parent/guardian was not willing to participate
- Does not have English fluency;
- Does not have access to Internet access
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of a Mobile Parent-based Intervention to Reduce Alcohol Use by High School Seniors
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.
Read the detailed description
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.
- Conditions
- Underage Drinking, Alcohol Use, Underage
- Being tested
- REAL Parenting, Active Control Materials
- Medical subject headings
- Underage Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REAL ParentingBehavioural
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.
Active Control MaterialsOther
NIAAA materials on underage drinking for parents
| Study group | Role | What they receive |
|---|---|---|
| REAL Parenting | Experimental | 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. Receives: Behavioral: REAL Parenting |
| Active Control Materials | Active comparator | NIAAA materials on underage drinking for parents Receives: Other: Active Control Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Use
A standard drink definition will be provided: a standard drink consists of 12 oz. beer or wine cooler, 8.5 oz. of malt liquor, 4 oz. of wine, 3.5 oz. fortified wine, or 1.5 oz. of hard liquor. Typical weekly drinking: participants will respond to the Daily Drinking Questionnaire(DDQ; Collins et al., 1985) to indicate number of drinks consumed on each day of a typical week within the past six months. Participants will report maximum number of drinks consumed on an occasion within the past month and number of hours spent drinking on that occasion using the Quantity/Frequency/Peak questionnaire (QFP; Dimeff et al., 1999; Marlatt et al., 1998). Drunkenness will be assessed by asking how many times in the past month participants have gotten drunk, or very high from alcohol using a 6-point scale: (0) never to (5) 9 or more. Heavy episodic drinking will be measured for females and males separately, asking for number of times they?ve had 4/5, respectively, drinks in a row within two hours.
Measured: Project years 1-2
Secondary outcomes (4)
Marijuana Use
Frequency of use will be assessed by asking how often participants used marijuana during the past six months using a 7-point scale ranging from (0) never to (6) 40 or more times.
Measured: Project years 1-2
Combined Use
Frequency of combined use will be assessed for participants indicating marijuana and nicotine use with a single item: During times you used marijuana, how often did you also drink alcohol? using a 6-point scale ranging from (0) never to (5) 40 or more times. For participants that indicate their peak drinking occasion a follow up question will assess whether marijuana or nicotine was also used(yes or no).
Measured: Project years 1-2
Consequences of Alcohol Use
Alcohol-related consequences (e.g., said or done embarrassing things, blackout) from the past six months will be measured using the established Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ; Read, Kahler, Strong, \& Colder, 2006). Response options will again be measured on the same a 7-point scale as Combined Use.
Measured: Project years 1-2
Nicotine Use
Frequency of use will be assessed by asking how often participants used nicotine products (tobacco, vaping, snuff) during the past six months using a 7-point scale ranging from (0) never to (6) 40 or more times.
Measured: Project years 1-2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start15 Jan 2021
- Primary completion15 Jan 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Underage DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Real Prevention, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Michael Hecht, Real Prevention, LLC
- Investigators
- Michael Hecht, Principal investigator, REAL Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932097
- Sponsor's protocol ID
- 11690
- Acronym
- RP
- Status last verified
- May 2023
- First submitted
- 25 Apr 2019
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Mobile Parent-based Intervention to Reduce Alcohol Use by High School Seniors
- ClinicalTrials.gov ID
- NCT03932097
- Acronym / sponsor ID
- RP / 11690
- Conditions
- Underage Drinking, Alcohol Use, Underage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Real Prevention, LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 30 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REAL Parenting | Experimental | Behavioral: REAL ParentingREAL 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. |
| Active Control Materials | Active comparator | Other: Active Control MaterialsNIAAA materials on underage drinking for parents |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- High school students (ages 15-18) who may be at risk for alcohol, marijuana and nicotine use and abuse, and whose parent/guardian is willing to participate in the proposed study as part of a parent/student dyad.
- High school students ages 15-18 with their parents/guardians; English fluency; Internet access; at least one parent/guardian fluent in English and with Internet access
Key exclusion criteria (4 listed)
- Not high school aged (not ages 15-18)
- Parent/guardian was not willing to participate
- Does not have English fluency;
- Does not have access to Internet access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REAL ParentingREAL 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. | Behavioural | REAL Parenting |
| Active Control MaterialsNIAAA materials on underage drinking for parents | Other | Active Control Materials |
Primary outcome
Alcohol Use
Time frame: Project years 1-2
A standard drink definition will be provided: a standard drink consists of 12 oz. beer or wine cooler, 8.5 oz. of malt liquor, 4 oz. of wine, 3.5 oz. fortified wine, or 1.5 oz. of hard liquor. Typical weekly drinking: participants will respond to the Daily Drinking Questionnaire(DDQ; Collins et al., 1985) to indicate number of drinks consumed on each day of a typical week within the past six months. Participants will report maximum number of drinks consumed on an occasion within the past month and number of hours spent drinking on that occasion using the Quantity/Frequency/Peak questionnaire (QFP; Dimeff et al., 1999; Marlatt et al., 1998). Drunkenness will be assessed by asking how many times in the past month participants have gotten drunk, or very high from alcohol using a 6-point scale: (0) never to (5) 9 or more. Heavy episodic drinking will be measured for females and males separately, asking for number of times they?ve had 4/5, respectively, drinks in a row within two hours.
4 secondary outcomes
Marijuana Use
Time frame: Project years 1-2
Combined Use
Time frame: Project years 1-2
Consequences of Alcohol Use
Time frame: Project years 1-2
Nicotine Use
Time frame: Project years 1-2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Hecht principal investigator
REAL Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REAL Parenting in people with Underage Drinking and Alcohol Use, Underage, run by Real Prevention, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Use (time frame: Project years 1-2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.