An interventional study of Personalized normative feedback in Heavy Drinking, sponsored by University of Houston. Completed at 1 site in United States. Open to participants aged 18 Years to 26 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-23.
Sponsored by University of Houston · Not applicable, Interventional, and Treatment
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.
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.
University of Houston is the lead sponsor of 101 studies on the registry; 17 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Not meeting any of the inclusion criteria Unwillingness to participate Failure to provide consent
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
Behavioral: Personalized normative feedback
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
Behavioral: Personalized normative feedback
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
Behavioral: Personalized normative feedback
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
Behavioral: Personalized normative feedback
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
Behavioral: Personalized normative feedback
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
Behavioral: Personalized normative feedback
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
Behavioral: Personalized normative feedback
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
Behavioral: Personalized normative feedback
Information presenting perceived and actual drinking norms.
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.
Time frame: 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).
Time frame: 3 months
Number of peak drinks consumed
Participants are asked to indicate the maximum number of drinks consumed on one occasion.
Time frame: 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.
Time frame: 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.
Time frame: 3 months
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.
Time frame: 3 months
Plan to share: No
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This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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