Heavy DrinkingNCT04639882
Motivating Recruitment and Efficacy in Normative Feedback Interventions
A study testing Personalized normative feedback in people with Heavy Drinking, run by University of Houston at 1 site in United States.
Trial summary
Excessive alcohol consumption among college students continues to be a serious public health concern associated with a wide range of negative consequences. Brief computer-based social norms interventions, including personalized normative feedback (PNF), have shown consistent effects in reducing problematic drinking in… Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Heavy Drinking
- What is being tested?
- Personalized normative feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 498 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2014to 31 Aug 2017
- 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 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Reporting one or more heavy drinking occasions (4/5 drinks on one drinking occasion for women/men) in the previous month Reporting one or more negative alcohol-related consequence in the previous month Being between 18 and 26 years of age Being a registered University of Houston student Providing consent to participate in the study
Who cannot join
- Not meeting any of the inclusion criteria Unwillingness to participate Failure to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Excessive alcohol consumption among college students continues to be a serious public health concern associated with a wide range of negative consequences. Brief computer-based social norms interventions, including personalized normative feedback (PNF), have shown consistent effects in reducing problematic drinking in this population, and there is some evidence that in-lab computer-delivered interventions may be more effective than remote interventions. Most studies have been conducted using generous incentives which may reduce the feasibility of dissemination on a larger scale and may undermine trial efficacy. In accordance with NIAAA aims, this research aims to (a) investigate delivery modality (i.e., in lab versus remotely) and incentives as important factors affecting the efficacy of PNF interventions and (b) develop intervention strategies that facilitate wider dissemination of inexpensive empirically-supported brief interventions for college students, thereby reducing problem drinking during a high-risk time period.
Read the detailed description
The current application evaluates motivational factors associated with recruitment into and efficacy of brief computer-delivered interventions for heavy drinking college students. College students are at increased risk for alcohol misuse compared to other adults, and development of efficacious intervention approaches is an urgent priority for NIAAA. Over the past several years empirical evidence has demonstrated support for computer-based personalized normative feedback (PNF) interventions which correct normative misperceptions of drinking and thereby reduce drinking behavior. Two specific questions which have remained largely unaddressed include whether the effectiveness of computer-based interventions depends on the location in which they are completed, and what is the optimal incentive structure to balance recruitment with motivational biases in intervention trials. A preliminary comparison of findings across several studies suggests that remote PNF interventions may be less effective than in-lab PNF interventions. However, the evidence is not conclusive because no study provides a direct comparison between delivery methods based on random assignment within the same study. This R21 recruited 498 heavy drinking college students and randomly assigned them to a 2 × 2 × 2 repeated measures design. Participants were randomly assigned to in-lab PNF, remote PNF, in-lab attention control, or remote attention control. Participants were also randomly assigned to receive no incentive ($0) or an incentive ($30) for participation. Assessments included baseline, postintervention, 3-month, and 6-month follow-ups. College students' motivational orientations, incentives, and typical drinking are expected to moderate differences between delivery methods. We expect that students who receive incentives for participating in intervention studies will be more likely to participate, but less likely to reduce drinking because they will be more likely to attribute their participation to extrinsic motivation. Further, students who receive computer-based PNF in the laboratory for no incentive are expected to exhibit the largest reductions in drinking. In contrast, students administered attention-control feedback remotely for an incentive ($30) are expected to exhibit the smallest reductions in drinking. Perceived value of intervention, retention of intervention content, and attribution for participation are expected to mediate incentive effects and differential efficacy of in-lab versus remote delivery. This research is expected to yield theoretical and practical improvements to feedback-based intervention strategies with potential to reduce drinking and related negative consequences with a stronger theoretical basis and at lower cost than have been previously available.
- Conditions
- Heavy Drinking
- Being tested
- Personalized normative feedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized normative feedbackBehavioural
Information presenting perceived and actual drinking norms.
| Study group | Role | What they receive |
|---|---|---|
| Control-Remote-$0 | Experimental | In this condition, Participants:
* receive attention control feedback
* complete the baseline and intervention procedure remotely
* are compensated $0 for completing the baseline and intervention procedure Receives: Behavioral: Personalized normative feedback |
| Control-Remote-$30 | Experimental | In this condition, Participants:
* receive attention control feedback
* complete the baseline and intervention procedure remotely
* are compensated $30 for completing the baseline and intervention procedure Receives: Behavioral: Personalized normative feedback |
| Control-InPerson-$0 | Experimental | In this condition, Participants:
* receive attention control feedback
* complete the baseline and intervention procedure in the research lab
* are compensated $0 for completing the baseline and intervention procedure Receives: Behavioral: Personalized normative feedback |
| Control-InPerson-$30 | Experimental | In this condition, Participants:
* receive attention control feedback
* complete the baseline and intervention procedure in the research lab
* are compensated $30 for completing the baseline and intervention procedure Receives: Behavioral: Personalized normative feedback |
| PNF-Remote-$0 | Experimental | In this condition, Participants:
* receive personalized normative feedback
* complete the baseline and intervention procedure remotely
* are compensated $0 for completing the baseline and intervention procedure Receives: Behavioral: Personalized normative feedback |
| PNF-Remote-$30 | Experimental | In this condition, Participants:
* receive personalized normative feedback
* complete the baseline and intervention procedure remotely
* are compensated $30 for completing the baseline and intervention procedure Receives: Behavioral: Personalized normative feedback |
| PNF-Inperson-$0 | Experimental | In this condition, Participants:
* receive personalized normative feedback
* complete the baseline and intervention procedure in the research lab
* are compensated $0 for completing the baseline and intervention procedure Receives: Behavioral: Personalized normative feedback |
| PNF-Inperson-$30 | Experimental | In this condition, Participants:
* receive personalized normative feedback
* complete the baseline and intervention procedure in the research lab
* are compensated $30 for completing the baseline and intervention procedure Receives: Behavioral: Personalized normative feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of drinks in past month - Timeline Follow-back (TLFB)
This measure asks participants to indicate how many drinks they consumed on each day of the previous month. Scores are summed.
Measured: 1 month
Number of drinks on a typical week - Daily Drinking Questionnaire (DDQ)
Participants are asked how many drinks they typically drink on each day of a typical week. These values are summed to create a drinks per week score. From Collins, Parks, and Marlatt (1985).
Measured: 3 months
Number of peak drinks consumed
Participants are asked to indicate the maximum number of drinks consumed on one occasion.
Measured: One month
Alcohol-related consequences: Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ)
A measure of 27 alcohol consequences. Participants indicate whether they have experienced the consequence or not and responses are summed to create a total score.
Measured: One month
Alcohol-related consequences: Rutgers Alcohol Problems Index (RAPI)
A measure of alcohol consequences. Participants indicate the frequency with which they have experienced each consequence; responses are summed to create a total score.
Measured: 3 months
Secondary outcomes (1)
Perception of number of drinks a typical college student drinks
The DDQ (Outcome 2) was modified to ask participants how often they think the typical college student of their same sex drinks in a typical week. Responses are again summed to create a total score. This measure is posited as a mediator of intervention efficacy on changes in drinking.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start10 Sep 2014
- Primary completion1 Jun 2016
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Heavy drinking college students (N=498) participated in a 2 (in-person vs. remote delivery) × 2 (compensation vs. no compensation) × 2 (PNF vs. control) design with follow-up assessments occurring remotely three and six months later.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 498 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clayton Neighbors, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639882
- Sponsor's protocol ID
- R21AA022369
- Status last verified
- Nov 2020
- First submitted
- 26 Oct 2020
- Last updated
- 23 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivating Recruitment and Efficacy in Normative Feedback Interventions
- ClinicalTrials.gov ID
- NCT04639882
- Acronym / sponsor ID
- R21AA022369
- Conditions
- Heavy Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- 10 Sep 2014 (actual)
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 23 Nov 2020 (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.
Excessive alcohol consumption among college students continues to be a serious public health concern associated with a wide range of negative consequences. Brief computer-based social norms interventions, including personalized normative feedback (PNF), have shown consistent effects in reducing problematic drinking in this population, and there is some evidence that in-lab computer-delivered interventions may be more effective than remote interventions. Most studies have been conducted using generous incentives which may reduce the feasibility of dissemination on a larger scale and may undermine trial efficacy. In accordance with NIAAA aims, this research aims to (a) investigate delivery modality (i.e., in lab versus remotely) and incentives as important factors affecting the efficacy of PNF interventions and (b) develop intervention strategies that facilitate wider dissemination of inexpensive empirically-supported brief interventions for college students, thereby reducing problem drinking during a high-risk time period.
Detailed description
The current application evaluates motivational factors associated with recruitment into and efficacy of brief computer-delivered interventions for heavy drinking college students. College students are at increased risk for alcohol misuse compared to other adults, and development of efficacious intervention approaches is an urgent priority for NIAAA. Over the past several years empirical evidence has demonstrated support for computer-based personalized normative feedback (PNF) interventions which correct normative misperceptions of drinking and thereby reduce drinking behavior. Two specific questions which have remained largely unaddressed include whether the effectiveness of computer-based interventions depends on the location in which they are completed, and what is the optimal incentive structure to balance recruitment with motivational biases in intervention trials. A preliminary comparison of findings across several studies suggests that remote PNF interventions may be less effective than in-lab PNF interventions. However, the evidence is not conclusive because no study provides a direct comparison between delivery methods based on random assignment within the same study. This R21 recruited 498 heavy drinking college students and randomly assigned them to a 2 × 2 × 2 repeated measures design. Participants were randomly assigned to in-lab PNF, remote PNF, in-lab attention control, or remote attention control. Participants were also randomly assigned to receive no incentive ($0) or an incentive ($30) for participation. Assessments included baseline, postintervention, 3-month, and 6-month follow-ups. College students' motivational orientations, incentives, and typical drinking are expected to moderate differences between delivery methods. We expect that students who receive incentives for participating in intervention studies will be more likely to participate, but less likely to reduce drinking because they will be more likely to attribute their participation to extrinsic motivation. Further, students who receive computer-based PNF in the laboratory for no incentive are expected to exhibit the largest reductions in drinking. In contrast, students administered attention-control feedback remotely for an incentive ($30) are expected to exhibit the smallest reductions in drinking. Perceived value of intervention, retention of intervention content, and attribution for participation are expected to mediate incentive effects and differential efficacy of in-lab versus remote delivery. This research is expected to yield theoretical and practical improvements to feedback-based intervention strategies with potential to reduce drinking and related negative consequences with a stronger theoretical basis and at lower cost than have been previously available.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 8
- Model description
- Heavy drinking college students (N=498) participated in a 2 (in-person vs. remote delivery) × 2 (compensation vs. no compensation) × 2 (PNF vs. control) design with follow-up assessments occurring remotely three and six months later.
| Arm | Type | Receives |
|---|---|---|
| Control-Remote-$0 | Experimental | Behavioral: Personalized normative feedbackIn this condition, Participants: * receive attention control feedback * complete the baseline and intervention procedure remotely * are compensated $0 for completing the baseline and intervention procedure |
| Control-Remote-$30 | Experimental | Behavioral: Personalized normative feedbackIn this condition, Participants: * receive attention control feedback * complete the baseline and intervention procedure remotely * are compensated $30 for completing the baseline and intervention procedure |
| Control-InPerson-$0 | Experimental | Behavioral: Personalized normative feedbackIn this condition, Participants: * receive attention control feedback * complete the baseline and intervention procedure in the research lab * are compensated $0 for completing the baseline and intervention procedure |
| Control-InPerson-$30 | Experimental | Behavioral: Personalized normative feedbackIn this condition, Participants: * receive attention control feedback * complete the baseline and intervention procedure in the research lab * are compensated $30 for completing the baseline and intervention procedure |
| PNF-Remote-$0 | Experimental | Behavioral: Personalized normative feedbackIn this condition, Participants: * receive personalized normative feedback * complete the baseline and intervention procedure remotely * are compensated $0 for completing the baseline and intervention procedure |
| PNF-Remote-$30 | Experimental | Behavioral: Personalized normative feedbackIn this condition, Participants: * receive personalized normative feedback * complete the baseline and intervention procedure remotely * are compensated $30 for completing the baseline and intervention procedure |
| PNF-Inperson-$0 | Experimental | Behavioral: Personalized normative feedbackIn this condition, Participants: * receive personalized normative feedback * complete the baseline and intervention procedure in the research lab * are compensated $0 for completing the baseline and intervention procedure |
| PNF-Inperson-$30 | Experimental | Behavioral: Personalized normative feedbackIn this condition, Participants: * receive personalized normative feedback * complete the baseline and intervention procedure in the research lab * are compensated $30 for completing the baseline and intervention procedure |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Reporting one or more heavy drinking occasions (4/5 drinks on one drinking occasion for women/men) in the previous month Reporting one or more negative alcohol-related consequence in the previous month Being between 18 and 26 years of age Being a registered University of Houston student Providing consent to participate in the study
Key exclusion criteria (1 listed)
- Not meeting any of the inclusion criteria Unwillingness to participate Failure to provide consent
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 normative feedbackInformation presenting perceived and actual drinking norms. | Behavioural | Control-InPerson-$0, Control-InPerson-$30, Control-Remote-$0, Control-Remote-$30, PNF-Inperson-$0, PNF-Inperson-$30, PNF-Remote-$0, PNF-Remote-$30 |
Primary outcome
Number of drinks in past month - Timeline Follow-back (TLFB)
Time frame: 1 month
This measure asks participants to indicate how many drinks they consumed on each day of the previous month. Scores are summed.
Number of drinks on a typical week - Daily Drinking Questionnaire (DDQ)
Time frame: 3 months
Participants are asked how many drinks they typically drink on each day of a typical week. These values are summed to create a drinks per week score. From Collins, Parks, and Marlatt (1985).
Number of peak drinks consumed
Time frame: One month
Participants are asked to indicate the maximum number of drinks consumed on one occasion.
Alcohol-related consequences: Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ)
Time frame: One month
A measure of 27 alcohol consequences. Participants indicate whether they have experienced the consequence or not and responses are summed to create a total score.
Alcohol-related consequences: Rutgers Alcohol Problems Index (RAPI)
Time frame: 3 months
A measure of alcohol consequences. Participants indicate the frequency with which they have experienced each consequence; responses are summed to create a total score.
1 secondary outcome
Perception of number of drinks a typical college student drinks
Time frame: 3 months
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 23 Nov 2020.
- Individual participant dataSharing planned: No
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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 normative feedback in people with Heavy Drinking, run by University of Houston 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 1 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 23 Nov 2020. 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?
Number of drinks in past month - Timeline Follow-back (TLFB) (time frame: 1 month). 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?
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 23 Nov 2020.