Alcohol DrinkingNCT03337438
Alcohol and Health: Personalized Feedback
A study testing Personalized Feedback Intervention with Values and Personalized Feedback Intervention Traditional in people with Alcohol Drinking and Alcohol Consumption, Youth, run by Oklahoma State University at 1 site in United States.
Trial summary
Heavy episodic drinking (HED) among college students remains a concern within the U.S., as rates of HED are still high in this population. Though a variety of brief motivational interventions for alcohol use in college students have demonstrated significant effects, these effects are often small and not consistently… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Alcohol Consumption, Youth
- What is being tested?
- Personalized Feedback Intervention with Values and Personalized Feedback Intervention Traditional
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2017to 29 Oct 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be at least 18 years of age
- Must be able to speak and read English
- Must report consuming alcohol in a typical week over the past month
Who cannot join
- Must not deny drinking within the past month
- Non-English speaking
- Under the age of 18
Trial locations and contacts
1 site in 1 country.
United States1 site
North Murray Hall Oklahoma State University
Stillwater, Oklahoma, 74078
About this study
Heavy episodic drinking (HED) among college students remains a concern within the U.S., as rates of HED are still high in this population. Though a variety of brief motivational interventions for alcohol use in college students have demonstrated significant effects, these effects are often small and not consistently maintained over time. Personalized feedback interventions (PFIs) are a particularly promising approach, as these are often acceptable to college students, as well as low-cost, and easy to disseminate. Though presentation of interperson discrepancy via descriptive and injunctive norms has shown consistent effects within PFIs and received much attention in the literature, intraperson, or ideal-actual self discrepancies, has largely been ignored. Drawing from cognitive dissonance theory, self-regulation theory, and motivational interviewing, the current study aims to evaluate the efficacy of an alcohol PFI with a values component to incorporate ideal-self discrepancy into a typical intervention.
- Conditions
- Alcohol Drinking, Alcohol Consumption, Youth
- Being tested
- Personalized Feedback Intervention with Values, Personalized Feedback Intervention Traditional
- Medical subject headings
- Alcohol Drinking, Underage Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Feedback Intervention with ValuesOther
The PFI with values will include information commonly included in personalized feedback interventions for alcohol use, such as norms information and drinking profile, as well as feedback on three of the assessed values that are highly important to the participant.
Personalized Feedback Intervention TraditionalOther
This PFI will include information on drinking profile, norms, behavioral strategies used while drinking, and practical costs related to drinking reframed as monetary values and caloric values.
| Study group | Role | What they receive |
|---|---|---|
| Values-PFI | Other | Not described Receives: Other: Personalized Feedback Intervention with Values |
| Traditional-PFI with values assessment | Other | Not described Receives: Other: Personalized Feedback Intervention Traditional |
| Traditional PFI no values assessment | Other | Not described Receives: Other: Personalized Feedback Intervention Traditional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol consumption
measured by drinks per week
Measured: one-month post baseline
Alcohol consequences
measured by the BYAACQ to determine number of consequences experienced in the past month post-baseline
Measured: one month post-baseline
Value-behavior discrepancy for values related to alcohol use
Measured by the VLQ-A to measure change in behavioral consistency with values specifically related to alcohol use one month post-baseline
Measured: one month post-baseline
Secondary outcomes (2)
Perceptions of norms
Perceptions of descriptive norms will be more accurate one month post-baseline
Measured: one month post-baseline
Trait mindfulness
Levels of mindfulness as measured by the FFMQ will be measured at both time points
Measured: one month post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start22 Oct 2017
- Primary completion29 Oct 2019
- Study completion29 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emma Brett, Oklahoma State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337438
- Sponsor's protocol ID
- AS1770
- Status last verified
- Oct 2019
- First submitted
- 27 Oct 2017
- Last updated
- 30 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol and Health: Personalized Feedback
- ClinicalTrials.gov ID
- NCT03337438
- Acronym / sponsor ID
- AS1770
- Conditions
- Alcohol Drinking, Alcohol Consumption, Youth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Oklahoma State UniversityUniversity, hospital or other
- Study start
- 22 Oct 2017 (actual)
- Primary completion
- 29 Oct 2019 (actual)
- Study completion
- 29 Oct 2019 (actual)
- First posted
- 9 Nov 2017 (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.
Heavy episodic drinking (HED) among college students remains a concern within the U.S., as rates of HED are still high in this population. Though a variety of brief motivational interventions for alcohol use in college students have demonstrated significant effects, these effects are often small and not consistently maintained over time. Personalized feedback interventions (PFIs) are a particularly promising approach, as these are often acceptable to college students, as well as low-cost, and easy to disseminate. Though presentation of interperson discrepancy via descriptive and injunctive norms has shown consistent effects within PFIs and received much attention in the literature, intraperson, or ideal-actual self discrepancies, has largely been ignored. Drawing from cognitive dissonance theory, self-regulation theory, and motivational interviewing, the current study aims to evaluate the efficacy of an alcohol PFI with a values component to incorporate ideal-self discrepancy into a typical intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Values-PFI | Other | Other: Personalized Feedback Intervention with Values |
| Traditional-PFI with values assessment | Other | Other: Personalized Feedback Intervention Traditional |
| Traditional PFI no values assessment | Other | Other: Personalized Feedback Intervention Traditional |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be at least 18 years of age
- Must be able to speak and read English
- Must report consuming alcohol in a typical week over the past month
Key exclusion criteria (3 listed)
- Must not deny drinking within the past month
- Non-English speaking
- Under the age of 18
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 |
|---|---|---|
| Personalized Feedback Intervention with ValuesThe PFI with values will include information commonly included in personalized feedback interventions for alcohol use, such as norms information and drinking profile, as well as feedback on three of the assessed values that are highly important to the participant. | Other | Values-PFI |
| Personalized Feedback Intervention TraditionalThis PFI will include information on drinking profile, norms, behavioral strategies used while drinking, and practical costs related to drinking reframed as monetary values and caloric values. | Other | Traditional PFI no values assessment, Traditional-PFI with values assessment |
Primary outcome
Alcohol consumption
Time frame: one-month post baseline
measured by drinks per week
Alcohol consequences
Time frame: one month post-baseline
measured by the BYAACQ to determine number of consequences experienced in the past month post-baseline
Value-behavior discrepancy for values related to alcohol use
Time frame: one month post-baseline
Measured by the VLQ-A to measure change in behavioral consistency with values specifically related to alcohol use one month post-baseline
2 secondary outcomes
Perceptions of norms
Time frame: one month post-baseline
Trait mindfulness
Time frame: one month post-baseline
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 30 Oct 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Feedback Intervention with Values and Personalized Feedback Intervention Traditional in people with Alcohol Drinking and Alcohol Consumption, Youth, run by Oklahoma State University 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 3 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 30 Oct 2019. 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 consumption (time frame: one-month post baseline). The study lists 3 primary outcomes in all. 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 30 Oct 2019.