Clinical trial NCT04639882: Motivating Recruitment and Efficacy in Normative Feedback Interventions
Official title: Motivating Recruitment and Efficacy in Normative Feedback Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heavy Drinking
Lead sponsor: University of Houston
Sponsor class: OTHER
First posted: 2020-11-23
Enrollment: 498
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of drinks in past month - Timeline Follow-back (TLFB)
timeFrame: 1 month
measure: Number of drinks on a typical week - Daily Drinking Questionnaire (DDQ)
timeFrame: 3 months
measure: Number of peak drinks consumed
timeFrame: One month
measure: Alcohol-related consequences: Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ)
timeFrame: One month
measure: Alcohol-related consequences: Rutgers Alcohol Problems Index (RAPI)
timeFrame: 3 months
Secondary outcomes:
measure: Perception of number of drinks a typical college student drinks
timeFrame: 3 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Houston
state: Texas
Study officials:
References: