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.
