NCT04975191

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

August 29, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 31, 2023

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

7 months

First QC Date

July 20, 2021

Results QC Date

February 9, 2023

Last Update Submit

May 9, 2023

Conditions

Alcohol Use, Unspecified

Outcome Measures

Primary Outcomes (2)

  • Change in Alcohol Use

    Number of participants who report alcohol use in the past 30 days

    Baseline-3 months

  • Change in Cannabis Use

    Number of participants who report cannabis use in the past 30 days

    Baseline-3 months

Secondary Outcomes (5)

  • Well-being as Assessed Using 14-item Questionnaire

    3 months

  • Mental Health as Assessed Using 8-item Questionnaire

    3 months

  • Resource Use

    3 months

  • Program Satisfaction

    3 months

  • Risk Comprehension as Assessed Using 10-item Questionnaire

    3 months

Study Arms (4)

Resources Program (RP)

OTHER
Behavioral: Resources

Personalized Feedback Program (PFP)

ACTIVE COMPARATOR
Behavioral: Personalized Feedback Program (PFP)

Brief motivational intervention (BMI)

ACTIVE COMPARATOR
Behavioral: Substance Use Feedback Program (BMI)

Combined PFP+BMI

ACTIVE COMPARATOR
Behavioral: Personalized Feedback Program (PFP)Behavioral: Substance Use Feedback Program (BMI)

Interventions

ResourcesBEHAVIORAL

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

Resources Program (RP)
Personalized Feedback Program (PFP)BEHAVIORAL

Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success

Combined PFP+BMIPersonalized Feedback Program (PFP)
Substance Use Feedback Program (BMI)BEHAVIORAL

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

Brief motivational intervention (BMI)Combined PFP+BMI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Age: Under the age of 18
  • Year in College: A sophomore, junior or senior
  • Enrollment Status: Enrolled part-time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (3)

  • 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.

    RESULT

  • 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.

    PMID: 4682398RESULT

  • 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.

    PMID: 20973032RESULT

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Health ResourcesBody Mass Index

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

Health PlanningHealth Care Economics and OrganizationsDelivery of Health CareHealth Care Quality, Access, and EvaluationBody Weights and MeasuresBody ConstitutionPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisAnthropometryInvestigative TechniquesPhysiological PhenomenaBiometryEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Results Point of Contact

Title
Dr. Danielle Dick
Organization
Rutgers University
Danielle.M.Dick@rutgers.edu
732-235-5607

Study Officials

  • Joshua Langberg, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2021

First Posted

July 23, 2021

Study Start

August 29, 2021

Primary Completion

March 23, 2022

Study Completion

March 23, 2022

Last Updated

May 31, 2023

Results First Posted

May 31, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)