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Personalized Feedback Programs for College Students

Personalized Feedback Programs for College Students

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04975191
Enrollment
252
Registered
2021-07-23
Start date
2021-08-29
Completion date
2022-03-23
Last updated
2023-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use, Unspecified

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.

Interventions

BEHAVIORALResources

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

BEHAVIORALPersonalized Feedback Program (PFP)

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

BEHAVIORALSubstance 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

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
Virginia Commonwealth University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Change in Alcohol UseBaseline-3 monthsNumber of participants who report alcohol use in the past 30 days
Change in Cannabis UseBaseline-3 monthsNumber of participants who report cannabis use in the past 30 days

Secondary

MeasureTime frameDescription
Resource Use3 monthsParticipants from each of the 4 groups were asked to indicate all of the VCU campus resources (e.g., recreation center, counseling center, writing center) they have utilized in the past 30 days from a list. Our team developed the list, which included 28 resources based on currently available resources for students at VCU. We summed the number of resources each participant used to create a resource use score. Scores ranged from 0 to 28 and corresponded to the number of resources the participant reported using (e.g., if the participant reported using 3 of the resources on the list, they received a score of 3 on the scale). Higher values represent higher levels of resource use, that is, a better outcome. Mean scores for each group were calculated and are displayed on the outcomes table below.
Well-being as Assessed Using 14-item Questionnaire3 monthsWell-being was measured with the 14 item Mental Health Continuum-Short Form (MHC-SF; Keyes, 2009; Lamers et al., 2011). Each item asks about past-month frequency of an aspect of positive mental health (e.g., I felt happy) with response options ranging from never to every day. Higher scores reflect more positive well-being. Item scores ranged from 0 to 5 per item. Items were averaged to create a mean well-being measure for which measure scores ranged from a minimum of 0 to a maximum of 5.
Risk Comprehension as Assessed Using 10-item Questionnaire3 monthsRisk comprehension will be assessed using 10 questions related to participants' beliefs about what factors contribute to substance use and mental health. Correct responses for each question were scored as 1, and incorrect responses were scored as 0. Responses are summed to yield a single score. Scores ranged from a minimum of 0 to a maximum of 10. Higher scores indicate higher knowledge of risk for substance use problems.
Program Satisfaction3 monthsTen items are included to assess participants' opinions about their condition. Response options include strongly disagree, disagree, neutral, agree, and strongly agree. Examples of the statements include The length of the program was appropriate and I learned new information as part of this program. Total scores were averaged to create a mean satisfaction score. Mean scores ranged from a minimum of 0 to a maximum of 5. Higher scores represented higher satisfaction with the program whereas lower scores represented dissatisfaction with the program.
Mental Health as Assessed Using 8-item Questionnaire3 monthsAnxiety and depressive symptoms. Abbreviated scales from the Symptom Checklist-90 will be used to assess anxiety and depressive symptoms occurring within the last 30 days (Derogatis, Lipman, & Covi, 1973). Four items measured anxiety symptoms, and four items assessed depressive symptoms. Responses were rated on a 5-point Likert-type scale (not at all, a little bit, moderately, quite a bit, and extremely). Total scores were calculated for both the anxiety and depression subscales. The scores on each subscale ranged from a minimum of 0 to a maximum of 16. Higher scores reflect higher levels of anxiety and depression.

Countries

United States

Participant flow

Participants by arm

ArmCount
Resources Program (RP)
Resources: Participants will be provided a list of resources available at VCU that are intended to support student success
65
Personalized Feedback Program (PFP)
Personalized Feedback Program (PFP): Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success
59
Brief Motivational Intervention (BMI)
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
61
Combined PFP+BMI
Personalized Feedback Program (PFP): Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success 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
60
Total245

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyLost to Follow-up13388
Overall StudyProtocol Violation1222

Baseline characteristics

CharacteristicResources Program (RP)TotalCombined PFP+BMIBrief Motivational Intervention (BMI)Personalized Feedback Program (PFP)
Age, Continuous18.28 years
STANDARD_DEVIATION 1.23
18.25 years
STANDARD_DEVIATION 0.76
18.19 years
STANDARD_DEVIATION 0.41
18.26 years
STANDARD_DEVIATION 0.49
18.28 years
STANDARD_DEVIATION 0.57
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants4 Participants0 Participants0 Participants4 Participants
Race (NIH/OMB)
Asian
14 Participants47 Participants6 Participants11 Participants16 Participants
Race (NIH/OMB)
Black or African American
12 Participants41 Participants10 Participants10 Participants9 Participants
Race (NIH/OMB)
More than one race
5 Participants26 Participants9 Participants6 Participants6 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants1 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants13 Participants6 Participants6 Participants1 Participants
Race (NIH/OMB)
White
33 Participants113 Participants29 Participants28 Participants23 Participants
Region of Enrollment
United States
65 participants245 participants60 participants61 participants59 participants
Sex/Gender, Customized
Sex
Female
57 Participants200 Participants48 Participants54 Participants41 Participants
Sex/Gender, Customized
Sex
Male
7 Participants43 Participants12 Participants7 Participants17 Participants
Sex/Gender, Customized
Sex
Refuse to state
1 Participants2 Participants0 Participants0 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 00 / 00 / 0
other
Total, other adverse events
0 / 00 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 00 / 0

Outcome results

Primary

Change in Alcohol Use

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

Time frame: Baseline-3 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Resources Program (RP)Change in Alcohol Use19 Participants
Personalized Feedback Program (PFP)Change in Alcohol Use17 Participants
Brief Motivational Intervention (BMI)Change in Alcohol Use22 Participants
Combined PFP+BMIChange in Alcohol Use18 Participants
Primary

Change in Cannabis Use

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

Time frame: Baseline-3 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Resources Program (RP)Change in Cannabis Use0 Participants
Personalized Feedback Program (PFP)Change in Cannabis Use5 Participants
Brief Motivational Intervention (BMI)Change in Cannabis Use12 Participants
Combined PFP+BMIChange in Cannabis Use19 Participants
Secondary

Mental Health as Assessed Using 8-item Questionnaire

Anxiety and depressive symptoms. Abbreviated scales from the Symptom Checklist-90 will be used to assess anxiety and depressive symptoms occurring within the last 30 days (Derogatis, Lipman, & Covi, 1973). Four items measured anxiety symptoms, and four items assessed depressive symptoms. Responses were rated on a 5-point Likert-type scale (not at all, a little bit, moderately, quite a bit, and extremely). Total scores were calculated for both the anxiety and depression subscales. The scores on each subscale ranged from a minimum of 0 to a maximum of 16. Higher scores reflect higher levels of anxiety and depression.

Time frame: 3 months

ArmMeasureGroupValue (MEAN)Dispersion
Resources Program (RP)Mental Health as Assessed Using 8-item QuestionnaireAnxiety5.12 score on a scaleStandard Deviation 4.12
Resources Program (RP)Mental Health as Assessed Using 8-item QuestionnaireDepression7.06 score on a scaleStandard Deviation 3.68
Personalized Feedback Program (PFP)Mental Health as Assessed Using 8-item QuestionnaireDepression6.46 score on a scaleStandard Deviation 3.9
Personalized Feedback Program (PFP)Mental Health as Assessed Using 8-item QuestionnaireAnxiety2.98 score on a scaleStandard Deviation 3.42
Brief Motivational Intervention (BMI)Mental Health as Assessed Using 8-item QuestionnaireAnxiety4.00 score on a scaleStandard Deviation 3.59
Brief Motivational Intervention (BMI)Mental Health as Assessed Using 8-item QuestionnaireDepression7.06 score on a scaleStandard Deviation 4.35
Combined PFP+BMIMental Health as Assessed Using 8-item QuestionnaireAnxiety4.32 score on a scaleStandard Deviation 4.35
Combined PFP+BMIMental Health as Assessed Using 8-item QuestionnaireDepression7.09 score on a scaleStandard Deviation 4.8
Secondary

Program Satisfaction

Ten items are included to assess participants' opinions about their condition. Response options include strongly disagree, disagree, neutral, agree, and strongly agree. Examples of the statements include The length of the program was appropriate and I learned new information as part of this program. Total scores were averaged to create a mean satisfaction score. Mean scores ranged from a minimum of 0 to a maximum of 5. Higher scores represented higher satisfaction with the program whereas lower scores represented dissatisfaction with the program.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
Resources Program (RP)Program Satisfaction4.4 score on a scaleStandard Deviation 3.68
Personalized Feedback Program (PFP)Program Satisfaction3.83 score on a scaleStandard Deviation 2.57
Brief Motivational Intervention (BMI)Program Satisfaction3.3 score on a scaleStandard Deviation 3.38
Combined PFP+BMIProgram Satisfaction4.3 score on a scaleStandard Deviation 2.82
Secondary

Resource Use

Participants from each of the 4 groups were asked to indicate all of the VCU campus resources (e.g., recreation center, counseling center, writing center) they have utilized in the past 30 days from a list. Our team developed the list, which included 28 resources based on currently available resources for students at VCU. We summed the number of resources each participant used to create a resource use score. Scores ranged from 0 to 28 and corresponded to the number of resources the participant reported using (e.g., if the participant reported using 3 of the resources on the list, they received a score of 3 on the scale). Higher values represent higher levels of resource use, that is, a better outcome. Mean scores for each group were calculated and are displayed on the outcomes table below.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
Resources Program (RP)Resource Use2 number of resourcesStandard Deviation 1.79
Personalized Feedback Program (PFP)Resource Use2.2 number of resourcesStandard Deviation 2.23
Brief Motivational Intervention (BMI)Resource Use1.52 number of resourcesStandard Deviation 1.53
Combined PFP+BMIResource Use2.02 number of resourcesStandard Deviation 2.09
Secondary

Risk Comprehension as Assessed Using 10-item Questionnaire

Risk comprehension will be assessed using 10 questions related to participants' beliefs about what factors contribute to substance use and mental health. Correct responses for each question were scored as 1, and incorrect responses were scored as 0. Responses are summed to yield a single score. Scores ranged from a minimum of 0 to a maximum of 10. Higher scores indicate higher knowledge of risk for substance use problems.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
Resources Program (RP)Risk Comprehension as Assessed Using 10-item Questionnaire8.33 score on a scaleStandard Deviation 1.5
Personalized Feedback Program (PFP)Risk Comprehension as Assessed Using 10-item Questionnaire8.41 score on a scaleStandard Deviation 1.78
Brief Motivational Intervention (BMI)Risk Comprehension as Assessed Using 10-item Questionnaire8.53 score on a scaleStandard Deviation 1.25
Combined PFP+BMIRisk Comprehension as Assessed Using 10-item Questionnaire8.65 score on a scaleStandard Deviation 1.42
Secondary

Well-being as Assessed Using 14-item Questionnaire

Well-being was measured with the 14 item Mental Health Continuum-Short Form (MHC-SF; Keyes, 2009; Lamers et al., 2011). Each item asks about past-month frequency of an aspect of positive mental health (e.g., I felt happy) with response options ranging from never to every day. Higher scores reflect more positive well-being. Item scores ranged from 0 to 5 per item. Items were averaged to create a mean well-being measure for which measure scores ranged from a minimum of 0 to a maximum of 5.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
Resources Program (RP)Well-being as Assessed Using 14-item Questionnaire2.91 score on a scaleStandard Deviation 0.95
Personalized Feedback Program (PFP)Well-being as Assessed Using 14-item Questionnaire2.98 score on a scaleStandard Deviation 0.99
Brief Motivational Intervention (BMI)Well-being as Assessed Using 14-item Questionnaire2.98 score on a scaleStandard Deviation 1.12
Combined PFP+BMIWell-being as Assessed Using 14-item Questionnaire2.9 score on a scaleStandard Deviation 1.07

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026