Heavy DrinkingNCT04016766
Brief Mobile Intervention for Prepartying
A study testing Mobile app prepartying intervention in people with Heavy Drinking, run by RAND at 1 site in United States.
Trial summary
The primary objective of the research study is to develop and test a prepartying (aka "pregaming") specific brief mobile app intervention that is intended to help college students reduce their prepartying drinking behavior. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Heavy Drinking
- What is being tested?
- Mobile app prepartying intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2021to 31 Aug 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 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- full time undergraduate college student
- between the ages of 18 and 24
- report typically prepartying at least once per week
Who cannot join
- not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Southern California
Los Angeles, California, 90089
Eric Pedersen, PhD, 310-694-7255, eric.pedersen@med.usc.edu
About this study
Official title: Mobile Application Intervention Targeting the High Risk Drinking Practice of Prepartying
The primary objective of the research study is to develop and test a prepartying (aka "pregaming") specific brief mobile app intervention that is intended to help college students reduce their prepartying drinking behavior. Such behavior has been identified as a major contributor to alcohol-related negative consequences among young people. The investigators will first develop the intervention content based on theory and research supporting mechanisms of change in brief interventions with college students and document normative drinking information from 500 college students for inclusion in the intervention content. Investigators will then beta test the intervention with a sample of 14 heavy drinking college students. Focus group feasibility and acceptability feedback will inform the final intervention content. Investigators will then pilot test the mobile-based intervention in a randomized controlled trial of 500 college students who preparty frequently (n = 250 intervention, n = 250 attention control) and determine the efficacy of the intervention on (1) preventing heavy consumption levels during and after prepartying and on (2) reducing students' global levels of heavy drinking and consequences one and three months post-intervention.
- Conditions
- Heavy Drinking
- Being tested
- Mobile app prepartying intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile app prepartying interventionBehavioural
The intervention is comprised of a theoretically-informed and empirically-supported, brief, accessible, and personalized intervention to address prepartying drinking. the prepartying intervention app will be tailored toward an individual's personal goals, beliefs (perceptions, expectancies, self-efficacy), and behavior (protective strategies), and focus on the core components of brief interventions that have been cited as constructs that mediate the effects of multiple component intervention programs (e.g., correcting perceived norms, use of protective behavioral strategies, increased self-efficacy, challenging expectancies, feedback on blood alcohol level).
| Study group | Role | What they receive |
|---|---|---|
| Prepartying mobile app intervention | Experimental | Mobile app intervention Receives: Behavioral: Mobile app prepartying intervention |
| Control | No intervention | Control participants receive a personalized attention control task (i.e., listing and ranking favorite movies, music, and books), which controls for the time needed by the intervention group to view the intervention material. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prepartying frequency
Number of days reported prepartying on the timeline followback
Measured: Past month (30 days)
Drinks during prepartying
Average number of drinks reported during prepartying on the timeline followback
Measured: Past month (30 days)
Drinking frequency
Number of days reported any drinking on the timeline followback
Measured: Past month (30 days)
Drinks on drinking days
Average number of drinks reported during drinking days on the timeline followback
Measured: Past month (30 days)
21-item Brief Young Adult Alcohol Consequences Questionnaire
Number of 21 assessed alcohol consequences experienced (yes/no). Yes responses are summed to yield a score on this measure. Higher scores indicate experience of a greater number of consequences. Scores range from 0 (no consequences) to 21 (experience of all 21 consequences)
Measured: Past month (30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start9 Aug 2021
- Primary completion31 May 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heavy 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
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016766
- Sponsor's protocol ID
- R34AA025968
- Status last verified
- Aug 2021
- First submitted
- 10 Jul 2019
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pedersen ER, Hummer JF, Davis JP, Fitzke RE, Tran DD, Witkiewitz K, Clapp JD. A mobile-based pregaming drinking prevention intervention for college students: A pilot randomized controlled trial. Psychol Addict Behav. 2023 Nov;37(7):841-852. doi: 10.1037/adb0000925. Epub 2023 Apr 13.
PubMed 37053413Pedersen ER, Hummer JF, Davis JP, Fitzke RE, Christie NC, Witkiewitz K, Clapp JD. A mobile-based pregaming drinking prevention intervention for college students: study protocol for a randomized controlled trial. Addict Sci Clin Pract. 2022 Jun 18;17(1):31. doi: 10.1186/s13722-022-00314-5.
PubMed 35717303
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Application Intervention Targeting the High Risk Drinking Practice of Prepartying
- ClinicalTrials.gov ID
- NCT04016766
- Acronym / sponsor ID
- R34AA025968
- Conditions
- Heavy Drinking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- University of Southern California
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 11 Jul 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.
The primary objective of the research study is to develop and test a prepartying (aka "pregaming") specific brief mobile app intervention that is intended to help college students reduce their prepartying drinking behavior. Such behavior has been identified as a major contributor to alcohol-related negative consequences among young people. The investigators will first develop the intervention content based on theory and research supporting mechanisms of change in brief interventions with college students and document normative drinking information from 500 college students for inclusion in the intervention content. Investigators will then beta test the intervention with a sample of 14 heavy drinking college students. Focus group feasibility and acceptability feedback will inform the final intervention content. Investigators will then pilot test the mobile-based intervention in a randomized controlled trial of 500 college students who preparty frequently (n = 250 intervention, n = 250 attention control) and determine the efficacy of the intervention on (1) preventing heavy consumption levels during and after prepartying and on (2) reducing students' global levels of heavy drinking and consequences one and three months post-intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prepartying mobile app intervention | Experimental | Behavioral: Mobile app prepartying interventionMobile app intervention |
| Control | No intervention | –Control participants receive a personalized attention control task (i.e., listing and ranking favorite movies, music, and books), which controls for the time needed by the intervention group to view the intervention material. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- full time undergraduate college student
- between the ages of 18 and 24
- report typically prepartying at least once per week
Key exclusion criteria (1 listed)
- not meeting inclusion criteria
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 |
|---|---|---|
| Mobile app prepartying interventionThe intervention is comprised of a theoretically-informed and empirically-supported, brief, accessible, and personalized intervention to address prepartying drinking. the prepartying intervention app will be tailored toward an individual's personal goals, beliefs (perceptions, expectancies, self-efficacy), and behavior (protective strategies), and focus on the core components of brief interventions that have been cited as constructs that mediate the effects of multiple component intervention programs (e.g., correcting perceived norms, use of protective behavioral strategies, increased self-efficacy, challenging expectancies, feedback on blood alcohol level). | Behavioural | Prepartying mobile app intervention |
Primary outcome
Prepartying frequency
Time frame: Past month (30 days)
Number of days reported prepartying on the timeline followback
Drinks during prepartying
Time frame: Past month (30 days)
Average number of drinks reported during prepartying on the timeline followback
Drinking frequency
Time frame: Past month (30 days)
Number of days reported any drinking on the timeline followback
Drinks on drinking days
Time frame: Past month (30 days)
Average number of drinks reported during drinking days on the timeline followback
21-item Brief Young Adult Alcohol Consequences Questionnaire
Time frame: Past month (30 days)
Number of 21 assessed alcohol consequences experienced (yes/no). Yes responses are summed to yield a score on this measure. Higher scores indicate experience of a greater number of consequences. Scores range from 0 (no consequences) to 21 (experience of all 21 consequences)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Derived from this study: PubMed 37053413Pedersen ER, Hummer JF, Davis JP, Fitzke RE, Tran DD, Witkiewitz K, Clapp JD. A mobile-based pregaming drinking prevention intervention for college students: A pilot randomized controlled trial. Psychol Addict Behav. 2023 Nov;37(7):841-852. doi: 10.1037/adb0000925. Epub 2023 Apr 13.
- Derived from this study: PubMed 35717303Pedersen ER, Hummer JF, Davis JP, Fitzke RE, Christie NC, Witkiewitz K, Clapp JD. A mobile-based pregaming drinking prevention intervention for college students: study protocol for a randomized controlled trial. Addict Sci Clin Pract. 2022 Jun 18;17(1):31. doi: 10.1186/s13722-022-00314-5.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile app prepartying intervention in people with Heavy Drinking, run by RAND 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric R Pedersen (310-393-0411 ext. 6078, ericp@rand.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prepartying frequency (time frame: Past month (30 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04016766, which also lists 2 linked publications.
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 17 Aug 2021.