Alcohol AbuseNCT03247647
Personal Values and Mandated Students
A study testing Enhanced Intervention and Standard Intervention in people with Alcohol Abuse, run by Brown University at 2 sites in United States.
Trial summary
This study aims to examine the efficacy of an enhanced alcohol intervention among individuals who are mandated to complete an alcohol education activity as part of a university sanction. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Abuse
- What is being tested?
- Enhanced Intervention and Standard Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 486 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Mar 2018to 30 Jan 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
- 18-24 years of age
- Enrolled in the university's undergraduate four-year degree program
- Have been mandated for violation of university alcohol policy.
Who cannot join
- Seniors who will graduate before the final 12-month follow-up
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Binghamton University
Binghamton, New York, 13902
Brown University
Providence, Rhode Island, 02903
About this study
Official title: Enhancing the Efficacy and Duration of a Brief Alcohol Intervention Using Self-Affirmation
This study aims to examine the efficacy of an enhanced alcohol intervention among individuals who are mandated to complete an alcohol education activity as part of a university sanction.
Read the detailed description
High volume drinking and related adverse consequences pose significant health concerns at US colleges and universities; drinking behavior often leads to students being sanctioned for violations of campus alcohol policy. Given the widespread use of mandated alcohol interventions for these students, optimizing their initial effects and their duration could substantially mitigate adverse alcohol outcomes. Self-affirmation represents a promising adjunct to brief alcohol interventions, particularly those delivered via computer that are popular but tend to have smaller effects. Basic research shows that when self-affirmation exercises precede the receipt of health information, they decrease defensiveness and resistance to threatening health information and increase acceptance and processing of health messages. Furthermore, the facilitative effects of self-affirmation are strongest among those at higher risk. Because many mandated students display both defensiveness and high drinking severity, use of self-affirmation to enhance information processing and reduce defensive responding could optimize the efficacy of an active alcohol intervention in this at-risk subpopulation. The investigators propose to use a two-group randomized design to investigate the effect of a self-affirmation exercise prior to an empirically supported brief alcohol intervention consisting of computer-delivered personalized normative feedback (PNF). Building on an extensive history of academic-student affairs collaborations, the investigators will recruit 450 mandated students from a large public university over the course of 5 semesters. The primary aim is to examine the additive effects of an initial self-affirmation (SA) manipulation prior to receiving PNF (SA + PNF) relative to Control + PNF on alcohol use and consequences. This study extends prior work by evaluating the ability of self-affirmation exercises to supplement active alcohol interventions (rather than just health messages), and tracking the impact on alcohol use over a longer (12-month) follow-up period. Secondary aims include (a) testing theoretically-derived mediation sequences that explain the SA + PNF effects on alcohol use and alcohol consequences, incorporating mechanisms of action associated with both self-affirmation and brief alcohol interventions, and (b) the examination of theoretical moderators of the effects of SA + PNF on alcohol use and alcohol consequences. The investigators will use latent growth curve modeling analyses to examine direct and indirect intervention effects on alcohol use and consequence trajectories from (pre-intervention) baseline assessment across 1-, 3-, 6-, 9- and 12-month follow-ups. The public health goal of this research is to reduce the acute and chronic effects of alcohol misuse by improving the efficacy of a low intensity brief alcohol intervention. The findings of this study have both practical and theoretical implications. Demonstration of the additive utility of a very brief self-affirmation exercise could improve the efficacy and impact of currently available computer-delivered interventions for mandated students; it may also expand the reach of self-affirmation theory, leading to adaptation of self-affirmation for use with other at-risk populations receiving brief alcohol interventions.
- Conditions
- Alcohol Abuse
- Being tested
- Enhanced Intervention, Standard Intervention
- Keywords
- Alcohol Intervention, College Students
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced InterventionBehavioural
Participants will complete a personal values task immediately before viewing feedback from eCheckUpToGo.
Standard InterventionBehavioural
Participants will write about the food they have eaten in the last 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Intervention | Experimental | Participants assigned to this arm will complete a personal values task before reviewing their personalized feedback (eCheckUpToGo). Receives: Behavioral: Enhanced Intervention |
| Standard Intervention | Placebo comparator | Participants assigned to this arm will complete a writing task about the food they have eaten in the past 48 hours immediately before reviewing their personalized feedback (eCheckUpToGo). Receives: Behavioral: Standard Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Consumption
Average of reports from past 30 days on the number of standard drinks consumed by participant per week.
Measured: 1 month after baseline
Secondary outcomes (1)
Alcohol-related consequences
Participant self-report on the Brief Young Adult Alcohol Consequences Questionnaire
Measured: 1 month and 3 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start13 Mar 2018
- Primary completion30 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alcohol AbuseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 486 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Binghamton University
- Responsible party
- Sponsor
- Investigators
- Kate B Carey, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247647
- Sponsor's protocol ID
- 1708001882
- Other IDs
- 1R01AA025643-01
- Status last verified
- Sep 2024
- First submitted
- 7 Aug 2017
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After all data have been collected and the results of the study have been published, de-identified data will be made available to other qualified investigators upon request. The request will be evaluated by the investigators to ensure that it meets reasonable demands of scientific integrity.
Publications
Carey KB, DiBello AM, Magill M, Mastroleo NR. Does self-affirmation augment the effects of a mandated personalized feedback intervention? A randomized controlled trial with heavy drinking college students. Psychol Addict Behav. 2024 Dec;38(8):836-849. doi: 10.1037/adb0000989. Epub 2024 Jan 18.
PubMed 38236233Hatch MR, Wilson SE, Mastroleo NR, DiBello AM, Carey KB. Values of College Students Mandated to an Alcohol Intervention: A Qualitative Examination. Subst Use Misuse. 2022;57(14):2094-2100. doi: 10.1080/10826084.2022.2136492. Epub 2022 Oct 31.
PubMed 36315498Wilson SE, Feltus SR, Brenman AM, Carey KB, DiBello AM, Mastroleo NR. Comparing Alcohol Use of Pre-COVID-Era and COVID-Era Cohorts of Mandated College Student Drinkers. J Stud Alcohol Drugs. 2022 Jul;83(4):480-485. doi: 10.15288/jsad.2022.83.480.
PubMed 35838424
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing the Efficacy and Duration of a Brief Alcohol Intervention Using Self-Affirmation
- ClinicalTrials.gov ID
- NCT03247647
- Acronym / sponsor ID
- 1708001882
- Conditions
- Alcohol Abuse
- Keywords
- Alcohol Intervention, College Students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 486 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Binghamton University
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 14 Aug 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.
This study aims to examine the efficacy of an enhanced alcohol intervention among individuals who are mandated to complete an alcohol education activity as part of a university sanction.
Detailed description
High volume drinking and related adverse consequences pose significant health concerns at US colleges and universities; drinking behavior often leads to students being sanctioned for violations of campus alcohol policy. Given the widespread use of mandated alcohol interventions for these students, optimizing their initial effects and their duration could substantially mitigate adverse alcohol outcomes. Self-affirmation represents a promising adjunct to brief alcohol interventions, particularly those delivered via computer that are popular but tend to have smaller effects. Basic research shows that when self-affirmation exercises precede the receipt of health information, they decrease defensiveness and resistance to threatening health information and increase acceptance and processing of health messages. Furthermore, the facilitative effects of self-affirmation are strongest among those at higher risk. Because many mandated students display both defensiveness and high drinking severity, use of self-affirmation to enhance information processing and reduce defensive responding could optimize the efficacy of an active alcohol intervention in this at-risk subpopulation. The investigators propose to use a two-group randomized design to investigate the effect of a self-affirmation exercise prior to an empirically supported brief alcohol intervention consisting of computer-delivered personalized normative feedback (PNF). Building on an extensive history of academic-student affairs collaborations, the investigators will recruit 450 mandated students from a large public university over the course of 5 semesters. The primary aim is to examine the additive effects of an initial self-affirmation (SA) manipulation prior to receiving PNF (SA + PNF) relative to Control + PNF on alcohol use and consequences. This study extends prior work by evaluating the ability of self-affirmation exercises to supplement active alcohol interventions (rather than just health messages), and tracking the impact on alcohol use over a longer (12-month) follow-up period. Secondary aims include (a) testing theoretically-derived mediation sequences that explain the SA + PNF effects on alcohol use and alcohol consequences, incorporating mechanisms of action associated with both self-affirmation and brief alcohol interventions, and (b) the examination of theoretical moderators of the effects of SA + PNF on alcohol use and alcohol consequences. The investigators will use latent growth curve modeling analyses to examine direct and indirect intervention effects on alcohol use and consequence trajectories from (pre-intervention) baseline assessment across 1-, 3-, 6-, 9- and 12-month follow-ups. The public health goal of this research is to reduce the acute and chronic effects of alcohol misuse by improving the efficacy of a low intensity brief alcohol intervention. The findings of this study have both practical and theoretical implications. Demonstration of the additive utility of a very brief self-affirmation exercise could improve the efficacy and impact of currently available computer-delivered interventions for mandated students; it may also expand the reach of self-affirmation theory, leading to adaptation of self-affirmation for use with other at-risk populations receiving brief alcohol interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Intervention | Experimental | Behavioral: Enhanced InterventionParticipants assigned to this arm will complete a personal values task before reviewing their personalized feedback (eCheckUpToGo). |
| Standard Intervention | Placebo comparator | Behavioral: Standard InterventionParticipants assigned to this arm will complete a writing task about the food they have eaten in the past 48 hours immediately before reviewing their personalized feedback (eCheckUpToGo). |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-24 years of age
- Enrolled in the university's undergraduate four-year degree program
- Have been mandated for violation of university alcohol policy.
Key exclusion criteria (1 listed)
- Seniors who will graduate before the final 12-month follow-up
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 |
|---|---|---|
| Enhanced InterventionParticipants will complete a personal values task immediately before viewing feedback from eCheckUpToGo. | Behavioural | Enhanced Intervention |
| Standard InterventionParticipants will write about the food they have eaten in the last 48 hours. | Behavioural | Standard Intervention |
Primary outcome
Alcohol Consumption
Time frame: 1 month after baseline
Average of reports from past 30 days on the number of standard drinks consumed by participant per week.
1 secondary outcome
Alcohol-related consequences
Time frame: 1 month and 3 months after 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 19 Sep 2024.
- Derived from this study: PubMed 38236233Carey KB, DiBello AM, Magill M, Mastroleo NR. Does self-affirmation augment the effects of a mandated personalized feedback intervention? A randomized controlled trial with heavy drinking college students. Psychol Addict Behav. 2024 Dec;38(8):836-849. doi: 10.1037/adb0000989. Epub 2024 Jan 18.
- Derived from this study: PubMed 36315498Hatch MR, Wilson SE, Mastroleo NR, DiBello AM, Carey KB. Values of College Students Mandated to an Alcohol Intervention: A Qualitative Examination. Subst Use Misuse. 2022;57(14):2094-2100. doi: 10.1080/10826084.2022.2136492. Epub 2022 Oct 31.
- Derived from this study: PubMed 35838424Wilson SE, Feltus SR, Brenman AM, Carey KB, DiBello AM, Mastroleo NR. Comparing Alcohol Use of Pre-COVID-Era and COVID-Era Cohorts of Mandated College Student Drinkers. J Stud Alcohol Drugs. 2022 Jul;83(4):480-485. doi: 10.15288/jsad.2022.83.480.
- Individual participant dataSharing planned: Yes. After all data have been collected and the results of the study have been published, de-identified data will be made available to other qualified investigators upon request. The request will be evaluated by the investigators to ensure that it meets reasonable demands of scientific integrity.
Related trials for Alcohol Abuse
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With of Alcohol Use Disorder (AUD)
Alcohol Use Disorder, Alcoholism
Recruiting
A SMART Evaluation of an Adaptive Web-based AUD Treatment for Service Members and Their Partners
Alcohol Abuse, Alcohol Use Disorder
Not yet recruitingPhase 1
The Impact of Dose on the Impairing, Intoxicating, and Abuse-Related Effects of Psilocybin
Psilocybin Intoxication
RecruitingPhase 2
Cannabis' Impact on Alcohol Consumption
Alcohol Drinking, Cannabis Use
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.
Kate B Carey, PhD principal investigator
Brown University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Intervention and Standard Intervention in people with Alcohol Abuse, run by Brown University at 2 sites 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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: 1 month after baseline). 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 NCT03247647, which also lists 3 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 19 Sep 2024.