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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04639882
Other study ID # R21AA022369
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 10, 2014
Est. completion date August 31, 2017

Study information

Verified date November 2020
Source University of Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 498
Est. completion date August 31, 2017
Est. primary completion date June 1, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 26 Years
Eligibility Inclusion Criteria: 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Personalized normative feedback
Information presenting perceived and actual drinking norms.

Locations

Country Name City State
United States University of Houston Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Houston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 month
Primary 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). 3 months
Primary Number of peak drinks consumed Participants are asked to indicate the maximum number of drinks consumed on one occasion. One month
Primary 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. One month
Primary 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. 3 months
Secondary 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. 3 months
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