Motivating Recruitment and Efficacy in Normative Feedback Interventions

November 16, 2020 updated by: Clayton Neighbors, University of Houston
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.

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

498

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Houston, Texas, United States, 77204
        • University of Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 26 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control-Remote-$0

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
Information presenting perceived and actual drinking norms.
Experimental: Control-Remote-$30

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
Information presenting perceived and actual drinking norms.
Experimental: Control-InPerson-$0

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
Information presenting perceived and actual drinking norms.
Experimental: Control-InPerson-$30

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
Information presenting perceived and actual drinking norms.
Experimental: PNF-Remote-$0

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
Information presenting perceived and actual drinking norms.
Experimental: PNF-Remote-$30

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
Information presenting perceived and actual drinking norms.
Experimental: PNF-Inperson-$0

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
Information presenting perceived and actual drinking norms.
Experimental: PNF-Inperson-$30

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
Information presenting perceived and actual drinking norms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month
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).
3 months
Number of peak drinks consumed
Time Frame: One month
Participants are asked to indicate the maximum number of drinks consumed on one occasion.
One month
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.
One month
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perception of number of drinks a typical college student drinks
Time Frame: 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

August 31, 2017

Study Registration Dates

First Submitted

October 26, 2020

First Submitted That Met QC Criteria

November 16, 2020

First Posted (Actual)

November 23, 2020

Study Record Updates

Last Update Posted (Actual)

November 23, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • R21AA022369 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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