Clinical trial NCT04975191: Personalized Feedback Programs for College Students
Official title: Personalized Feedback Programs for College Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use, Unspecified
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2021-07-23
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Alcohol Use
timeFrame: Baseline-3 months
measure: Change in Cannabis Use
timeFrame: Baseline-3 months
Secondary outcomes:
measure: Well-being as Assessed Using 14-item Questionnaire
timeFrame: 3 months
measure: Mental Health as Assessed Using 8-item Questionnaire
timeFrame: 3 months
measure: Resource Use
timeFrame: 3 months
measure: Program Satisfaction
timeFrame: 3 months
measure: Risk Comprehension as Assessed Using 10-item Questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Joshua Langberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Keyes, C. L. (2009). Brief description of the mental health continuum short form (MHC-SF). Scale retrieved from https://www.psytoolkit.org/survey-library/mhc-sf.html.
citation: Derogatis LR, Lipman RS, Covi L. SCL-90: an outpatient psychiatric rating scale--preliminary report. Psychopharmacol Bull. 1973 Jan;9(1):13-28. No abstract available.
citation: Lamers SM, Westerhof GJ, Bohlmeijer ET, ten Klooster PM, Keyes CL. Evaluating the psychometric properties of the Mental Health Continuum-Short Form (MHC-SF). J Clin Psychol. 2011 Jan;67(1):99-110. doi: 10.1002/jclp.20741.