Personalized Feedback Programs for College Students

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Completed
CT.gov ID
NCT04975191
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
251
1
4
6.8
37.1

Study Details

Study Description

Brief Summary

The purpose of this research study is to evaluate the effectiveness of different forms of personalized feedback intended to help students make their best personal choices to support their health and well-being in college.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Resources
  • Behavioral: Personalized Feedback Program (PFP)
  • Behavioral: Substance Use Feedback Program (BMI)
N/A

Detailed Description

Risky substance use among college students is a widespread challenge that requires innovative prevention methods to address. A primary aim of this study is to assess the efficacy of receiving different types of personalized feedback on the substance use and wellbeing of college students. This preliminary efficacy will be evaluated through a multi-part randomized controlled trial comparing four conditions: (1) resources program, (2) on-line Personalized Feedback Program (PFP), (3) on-line Substance Use Feedback Program (based on brief motivational intervention (BMI) principles), and (4) PFP+BMI.

At the first time point, participants will be randomly selected into one of four conditions. Participants have an equal chance of being assigned to any one of the conditions. All participants will complete follow-up surveys at two additional timepoints (30 day follow-up; 3-month follow-up) to determine any changes that have occurred since they took part in their program at Time Point 1.

After the final survey, all participants, regardless of their initial group, will be invited to receive all of the personalized feedback components available across all conditions.

Findings from this study have great potential to enhance the effectiveness of college student substance use prevention programming and improve college student wellbeing.

Study Design

Study Type:
Interventional
Actual Enrollment :
251 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Personalized Feedback Programs for College Students
Actual Study Start Date :
Aug 29, 2021
Actual Primary Completion Date :
Mar 23, 2022
Actual Study Completion Date :
Mar 23, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Resources Program (RP)

Behavioral: Resources
Participants will be provided a list of resources available at VCU that are intended to support student success

Active Comparator: Personalized Feedback Program (PFP)

Behavioral: Personalized Feedback Program (PFP)
Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success

Active Comparator: Brief motivational intervention (BMI)

Behavioral: Substance Use Feedback Program (BMI)
Participants will complete an online program based on brief motivational intervention (BMI) content/principles that explores their current substance use patterns to make personalized recommendations for success

Active Comparator: Combined PFP+BMI

Behavioral: Personalized Feedback Program (PFP)
Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success

Behavioral: Substance Use Feedback Program (BMI)
Participants will complete an online program based on brief motivational intervention (BMI) content/principles that explores their current substance use patterns to make personalized recommendations for success

Outcome Measures

Primary Outcome Measures

  1. Change in Alcohol Use as assessed using 20-item questionnaire [Baseline-3 months]

    Change in alcohol use will be assessed using twenty items focused on behaviors and experiences associated with alcohol use.

  2. Change in Substance Use as assessed using 6-item questionnaire [Baseline-3 months]

    Change in other substance use (not alcohol) will be assessed using six items focused on substance use frequency.

Secondary Outcome Measures

  1. Change in Well-being as assessed using 14-item questionnaire [Baseline-3 months]

    Change in well-being will be assessed using 14 items from the which ask about the following three domains: emotional, social, and psychological well-being. These domains will be combined to give participants an overall well-being score.

  2. Change in Mental health as assessed using 8-item questionnaire [Baseline-3 months]

    Change in mental health will be assessed using 8 items which ask about how much discomfort various problems have caused the participant.

  3. Change in Resource use [Baseline-3 months]

    Participants will be provided with a checklist of available campus resources at Virginia Commonwealth University (VCU) and asked which of the following VCU campus resources they've used. Our team developed the list of resources based on currently available resources for students at VCU.

  4. Program Satisfaction questionnaire [3 months]

    Participants will be asked questions related to their satisfaction with their assigned program. Number of questions varies from 6 to 14, depending on the assigned program. Scores will be averaged to yield comparable scores across programs.

  5. Change in Risk Comprehension as assessed using 10-item questionnaire [Baseline-3 months]

    Change in risk comprehension will be assessed using 10 questions related to participants' beliefs about what factors contribute to substance use and mental health. Responses are summed to yield a single score.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Consent: Voluntary consent must be provided.

  • Age: Students over the age of 18 may participate.

  • Year in college: Newly enrolled freshmen.

  • Enrollment status: Only full-time VCU students will participate.

Exclusion Criteria:
  • Age: Under the age of 18

  • Year in College: A sophomore, junior or senior

  • Enrollment Status: Enrolled part-time

Contacts and Locations

Locations

Site City State Country Postal Code
1 Virginia Commonwealth University Richmond Virginia United States 23298

Sponsors and Collaborators

  • Virginia Commonwealth University
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Joshua Langberg, PhD, Virginia Commonwealth University

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT04975191
Other Study ID Numbers:
  • HM20022611
  • R34AA027347
First Posted:
Jul 23, 2021
Last Update Posted:
May 25, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 25, 2022