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Parent Feedback Intervention Targeting Student Transitions and Alcohol Related Trajectories (+) Efficacy Study

Extension and Online Adaptation of the FITSTART Parent-based Intervention to Reduce Drinking Among First-year Students

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04549454
Acronym
FITSTART+
Enrollment
266
Registered
2020-09-16
Start date
2021-07-22
Completion date
2022-03-22
Last updated
2023-06-01

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

Conditions

Alcohol Drinking, Alcohol Problem Drinking, Parenting

Keywords

Parent Intervention, Alcohol Intervention, College Student Drinking

Brief summary

FITSTART (Feedback Intervention Targeting Student Transitions and Risk Trajectories) is a parent-based social norms intervention that has been shown to reduce risky drinking in incoming first year students.This program uses normative feedback to correct parents overestimation of other parents negative alcohol-related parenting practices (e.g., number of drinks parents would permit their college student to consume). Theory and research suggests that correcting those common misperceptions can motivate parents to adjust their own behaviors (e.g., reducing the number of drinks they would permit), which, in turn, can impact college student drinking. Despite FITSTARTs success, the design of the program limits participation to only students who have parents who can attend on-campus orientation sessions during the summer months before the start of the Fall semester. To address this limitation and extend the previous work, the proposed randomized clinical trial (RCT) will evaluate the efficacy of an online adaptation of the FITSTART(+) PBI program. To examine the efficacy of the newly developed FITSTART+ PBI web app, the proposed RCT will use a longitudinal design to examine if students self-report drinking and related negative consequences during their first semester in college significantly differed between FITSTART+ PBI (intervention app) and a control version of the app. Self-reported drinking and consequences are expected to be lower amongst students with parents randomized to FITSTART+ PBI relative to those with parents randomized to the control app.

Detailed description

Heavy episodic drinking (HED) rates remains at unacceptably high levels on college campuses. Researchers on parent-based interventions (PBIs) has revealed promising results. but studies have generally failed to reduce HED in college students. FITSTART was developed to address two limitations of traditional PBIs that may contribute to the lack of the aforementioned effects: (I) they are purely informational and (II) they typically lack a motivational component to capture parents' attention and increase motivation to proactively engage their students. Pilot work has revealed that parents display predictable normative misperceptions (e.g., overestimate how approving other parents are of drinking and underestimate how often other parents engage with their students about drinking). As predicted by social norms theory, these false beliefs are associated with parents displaying more approving attitudes themselves and communicating less frequently. Correcting these norms should motivate parents to proactively engage their child in risk-reducing directions. FITSTART combined a social norms feedback component with informational material (tips) characteristic of a traditional PBI in an in-person interactive format and successfully reduced HED. While the effects on weekly drinking, HED, and non-drinker alcohol use initiation were robust 1-month into college (3-months post intervention). FITSTART's usefulness as a universal approach is limited because it was delivered to parent groups on-campus during pre-college orientation sessions and many colleges do not hold summer orientations and/or lack the resources to administer FITSTART. To address this limitation, a web-based platform (or app) was developed using a new cutting-edge modality that draws from the computer science literature on virtual co-presence to create an online environment that mimics the effects of a live group social norms session. The current pilot study seeks to evaluate the efficacy of the FITSTART+ PBI in a randomized control trial (RCT) by evaluating changes in incoming first-year students' alcohol use and related negative consequences during the transition into college. The sample will consist of traditional first year students (17-20 years of age) from Loyola Marymount University who completed consent and the baseline survey, and whose parents downloaded and registered for the FITSTART+ intervention or control app. Parents will be invited to download the intervention/control app two weeks prior to their student's arrival on campus in the fall (beginning of August). To examine the short- and long-term effects of the intervention, students will complete a baseline survey at the end of July (pre- matriculation) and two follow-up surveys, approximately 1 month (October) and 6 months (April) after the students arrive on campus in the spring.

Interventions

BEHAVIORALFITSTART+ PBI

Personalized normative feedback on other parents behaviors + alcohol-specific parenting advice + general parenting advice

BEHAVIORALGeneral Parenting Advice

General parenting advice

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
Loyola Marymount University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

Intervention condition is randomly assigned and the intervention delivery is digital, through a web app. Senior members of the research team will have a record of the participants randomized to each condition but the delivery of all intervention content is automated within the app. Junior members of the research team responsible for tracking participants and sending follow-up survey reminders will not be aware of participant condition assignment.

Eligibility

Sex/Gender
ALL
Age
17 Years to 20 Years
Healthy volunteers
Yes

Inclusion criteria

First-year incoming LMU student consented to participate in the study and their parent/guardian created a profile on the app

Exclusion criteria

Outside of the students age range

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline Typical Weekly Drinking at 1 Monthbaseline, 1 monthAt baseline and the 1-month follow-up, participants reported the typical quantity of standard alcohol drinks consumed on each day of the week during the past 30 days using the Daily Drinking Questionnaire. Quantity of drinks reported on each day of the week at baseline and 1-month were then summed (separately) to create a composite variable assessing typical weekly drinking at each time point. To compute the outcome, the 1-month measure of typical drinks per week was subtracted from the baseline measure of typical drinks per week such that a positive value indicates a decrease in consumption during this period and a negative value indicates an increase in consumption during this period.
Change From Baseline Typical Weekly Drinking at 6 Monthsbaseline, 6 monthsAt baseline and the 6-month follow-up, participants reported the typical quantity of standard alcohol drinks consumed on each day of the week during the past 30 days using the Daily Drinking Questionnaire. Quantity of drinks reported on each day of the week at baseline and 1-month were then summed (separately) to create a composite variable assessing typical weekly drinking at each time point. To compute the outcome, the 6-month measure of typical drinks per week was subtracted from the baseline measure of typical drinks per week such that a positive value indicates a decrease in consumption during this period and a negative value indicates an increase in consumption during this period.
Change From Baseline Frequency of Alcohol Consequences at 1 Monthbaseline, 1 monthAt baseline and the 1-month follow-up, the number of types of negative alcohol-related consequences experienced out of a list of 14 common negative alcohol-related consequences (past 30 days) were summed to create a composite variable at each time point. To compute the outcome, the 1-month measure of negative consequences was subtracted from the baseline measure of negative consequences such that a positive value indicates a decrease in consequences during this period and a negative value indicates an increase in consequences during this period.
Change From Baseline Frequency of Alcohol Consequences at 6 Monthsbaseline, 6 monthsAt baseline and the 6-month follow-up, the number of types of negative alcohol-related consequences experienced out of a list of 14 common negative alcohol-related consequences (past 30 days) were summed to create a composite variable at each time point. To compute the outcome, the 6-month measure of negative consequences was subtracted from the baseline measure of negative consequences such that a positive value indicates a decrease in consequences during this period and a negative value indicates an increase in consequences during this period.
Change From Baseline Quantity/Frequency/Peak Alcohol Use at 1 Monthbaseline, 1 monthAt baseline and the 1-month follow-up, an item assessing the number of maximum drinks on one occasion from the Frequency, Quantity, Max (FQM) measure was used to assess peak drinks on one occasion over the past 30 days. To compute the outcome, the 1-month measure of peak drinks was subtracted from the baseline measure of peak drinks such that a positive value indicates a decrease in consumption during this period and a negative value indicates an increase in consumption during this period.
Change From Baseline Quantity/Frequency/Peak Alcohol Use at 6 Monthsbaseline, 6 monthsAt baseline and the 6-month follow-up, an item assessing the number of maximum drinks on one occasion from the Frequency, Quantity, Max (FQM) measure was used to assess peak drinks on one occasion over the past 30 days. To compute the outcome, the 6-month measure of peak drinks was subtracted from the baseline measure of peak drinks such that a positive value indicates a decrease in consumption during this period and a negative value indicates an increase in consumption during this period.
Change From Baseline Heavy Episodic Drinking at 1 Monthbaseline, 1 monthAt baseline and the 1-month follow-up, an item assessing the number of times students reported a heavy episodic drinking (HED) event in the past two weeks. To compute the outcome, the 1-month measure of HED was subtracted from the baseline measure of HED such that a positive value indicates a decrease in HED events during this period and a negative value indicates an increase in HED events during this period.
Change From Baseline Heavy Episodic Drinking at 6 Monthsbaseline, 6 monthsAt baseline and the 1-month follow-up, an item assessing the number of times students reported a heavy episodic drinking (HED) event in the past two weeks. To compute the outcome, the 1-month measure of HED was subtracted from the baseline measure of HED such that a positive value indicates a decrease in HED events during this period and a negative value indicates an increase in HED events during this period.

Countries

United States

Participant flow

Recruitment details

The university's admission's office emailed eligible first-year students an invite to take part in a 3-part longitudinal survey study (July 2021). Parents of students who completed the baseline survey were invited via email to join a free online program designed to help them support their student's college transition (Aug 2021). Invited parents were randomized to receive a web URL linking to either the intervention or control version of the program.

Participants by arm

ArmCount
Intervention App
Students in arm of the study will have a parent who has access to the following content in the parent app: (a) FITSTART+ PBI materials (personalized normative feedback quiz, information on college student drinking, and alcohol-specific advice for parents of first year students); (b) general advice for parents of college students (e.g., improving communication; reducing conflict); (c) information about university resources; and (d) a community section (parents can view other parent profiles, submit family photos, and view family photos submitted by other parents). FITSTART+ PBI: Personalized normative feedback on other parents behaviors + alcohol-specific parenting advice + general parenting advice
134
Control App
Students in this arm of the study will have a parent who has access to the following content in the parent app: (a) general advice for parents of college students (e.g., improving communication; reducing conflict); (b) information about university resources; and (c) a community section (parents can view other parent profiles, submit family photos, and view family photos submitted by other parents). General Parenting Advice: General parenting advice
132
Total266

Withdrawals & dropouts

PeriodReasonFG000FG001
T1 to T2Lost to Follow-up2226
T1 to T3Lost to Follow-up3136

Baseline characteristics

CharacteristicIntervention AppTotalControl App
Age, Categorical
<=18 years
129 Participants253 Participants124 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
5 Participants13 Participants8 Participants
Age, Continuous17.91 years
STANDARD_DEVIATION 0.4
17.91 years
STANDARD_DEVIATION 0.42
17.91 years
STANDARD_DEVIATION 0.45
Consequences1.34 Types of alcohol consequences
STANDARD_DEVIATION 1.96
1.34 Types of alcohol consequences
STANDARD_DEVIATION 2
1.35 Types of alcohol consequences
STANDARD_DEVIATION 2.04
Ethnicity (NIH/OMB)
Hispanic or Latino
32 Participants66 Participants34 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
102 Participants200 Participants98 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
HED0.42 HED events
STANDARD_DEVIATION 1.05
0.49 HED events
STANDARD_DEVIATION 1.26
0.56 HED events
STANDARD_DEVIATION 1.44
Quantity/Frequency/Peak Alcohol Use1.78 Peak alcoholic beverages consumed
STANDARD_DEVIATION 2.53
1.97 Peak alcoholic beverages consumed
STANDARD_DEVIATION 2.86
2.17 Peak alcoholic beverages consumed
STANDARD_DEVIATION 3.16
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
17 Participants32 Participants15 Participants
Race (NIH/OMB)
Black or African American
14 Participants30 Participants16 Participants
Race (NIH/OMB)
More than one race
32 Participants57 Participants25 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants5 Participants3 Participants
Race (NIH/OMB)
White
69 Participants141 Participants72 Participants
Region of Enrollment
United States
134 participants266 participants132 participants
Sex: Female, Male
Female
79 Participants154 Participants75 Participants
Sex: Female, Male
Male
55 Participants112 Participants57 Participants
Typical Weekly Drinking1.97 Typical alcohol drinks consumed per week
STANDARD_DEVIATION 3.7
1.97 Typical alcohol drinks consumed per week
STANDARD_DEVIATION 3.74
1.98 Typical alcohol drinks consumed per week
STANDARD_DEVIATION 3.78

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1340 / 132
other
Total, other adverse events
0 / 1340 / 132
serious
Total, serious adverse events
0 / 1340 / 132

Outcome results

Primary

Change From Baseline Frequency of Alcohol Consequences at 1 Month

At baseline and the 1-month follow-up, the number of types of negative alcohol-related consequences experienced out of a list of 14 common negative alcohol-related consequences (past 30 days) were summed to create a composite variable at each time point. To compute the outcome, the 1-month measure of negative consequences was subtracted from the baseline measure of negative consequences such that a positive value indicates a decrease in consequences during this period and a negative value indicates an increase in consequences during this period.

Time frame: baseline, 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention AppChange From Baseline Frequency of Alcohol Consequences at 1 Month0.24 types of alcohol consequencesStandard Deviation 1.71
Control AppChange From Baseline Frequency of Alcohol Consequences at 1 Month0.28 types of alcohol consequencesStandard Deviation 2.22
Comparison: As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on consequences. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in consequences from baseline to the 1-month follow-up in the Intervention Arm versus the Control Arm.p-value: 0.889Tukey-Kramer
Primary

Change From Baseline Frequency of Alcohol Consequences at 6 Months

At baseline and the 6-month follow-up, the number of types of negative alcohol-related consequences experienced out of a list of 14 common negative alcohol-related consequences (past 30 days) were summed to create a composite variable at each time point. To compute the outcome, the 6-month measure of negative consequences was subtracted from the baseline measure of negative consequences such that a positive value indicates a decrease in consequences during this period and a negative value indicates an increase in consequences during this period.

Time frame: baseline, 6 months

ArmMeasureValue (MEAN)Dispersion
Intervention AppChange From Baseline Frequency of Alcohol Consequences at 6 Months.52 types of alcohol consequencesStandard Deviation 2.84
Control AppChange From Baseline Frequency of Alcohol Consequences at 6 Months.73 types of alcohol consequencesStandard Deviation 3.3
Comparison: As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on consequences. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in consequences from baseline to the 6-month follow-up in the Intervention Arm versus the Control Arm.p-value: 0.582Tukey-Kramer
Primary

Change From Baseline Heavy Episodic Drinking at 1 Month

At baseline and the 1-month follow-up, an item assessing the number of times students reported a heavy episodic drinking (HED) event in the past two weeks. To compute the outcome, the 1-month measure of HED was subtracted from the baseline measure of HED such that a positive value indicates a decrease in HED events during this period and a negative value indicates an increase in HED events during this period.

Time frame: baseline, 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention AppChange From Baseline Heavy Episodic Drinking at 1 Month.41 HED eventsStandard Deviation 1.27
Control AppChange From Baseline Heavy Episodic Drinking at 1 Month.47 HED eventsStandard Deviation 1.44
Comparison: As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on HED. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in HED from baseline to the 1-month follow-up in the Intervention Arm versus the Control Arm.p-value: 0.889Tukey-Kramer
Primary

Change From Baseline Heavy Episodic Drinking at 6 Months

At baseline and the 1-month follow-up, an item assessing the number of times students reported a heavy episodic drinking (HED) event in the past two weeks. To compute the outcome, the 1-month measure of HED was subtracted from the baseline measure of HED such that a positive value indicates a decrease in HED events during this period and a negative value indicates an increase in HED events during this period.

Time frame: baseline, 6 months

ArmMeasureValue (MEAN)Dispersion
Intervention AppChange From Baseline Heavy Episodic Drinking at 6 Months.67 HED eventsStandard Deviation 1.67
Control AppChange From Baseline Heavy Episodic Drinking at 6 Months.56 HED eventsStandard Deviation 1.5
Comparison: As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on HED. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in HED from baseline to the 6-month follow-up in the Intervention Arm versus the Control Arm.p-value: 0.582Tukey-Kramer
Primary

Change From Baseline Quantity/Frequency/Peak Alcohol Use at 1 Month

At baseline and the 1-month follow-up, an item assessing the number of maximum drinks on one occasion from the Frequency, Quantity, Max (FQM) measure was used to assess peak drinks on one occasion over the past 30 days. To compute the outcome, the 1-month measure of peak drinks was subtracted from the baseline measure of peak drinks such that a positive value indicates a decrease in consumption during this period and a negative value indicates an increase in consumption during this period.

Time frame: baseline, 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention AppChange From Baseline Quantity/Frequency/Peak Alcohol Use at 1 Month.91 Peak alcoholic beverages consumedStandard Deviation 2.46
Control AppChange From Baseline Quantity/Frequency/Peak Alcohol Use at 1 Month.98 Peak alcoholic beverages consumedStandard Deviation 2.63
Comparison: As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on peak drinks. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in peak drinks from baseline to the 1-month follow-up in the Intervention Arm versus the Control Arm.p-value: 0.523Tukey-Kramer
Primary

Change From Baseline Quantity/Frequency/Peak Alcohol Use at 6 Months

At baseline and the 6-month follow-up, an item assessing the number of maximum drinks on one occasion from the Frequency, Quantity, Max (FQM) measure was used to assess peak drinks on one occasion over the past 30 days. To compute the outcome, the 6-month measure of peak drinks was subtracted from the baseline measure of peak drinks such that a positive value indicates a decrease in consumption during this period and a negative value indicates an increase in consumption during this period.

Time frame: baseline, 6 months

ArmMeasureValue (MEAN)Dispersion
Intervention AppChange From Baseline Quantity/Frequency/Peak Alcohol Use at 6 Months1.54 Peak alcoholic beverages consumedStandard Deviation 3.43
Control AppChange From Baseline Quantity/Frequency/Peak Alcohol Use at 6 Months1.36 Peak alcoholic beverages consumedStandard Deviation 3.25
Comparison: As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on peak drinks. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in peak drinks from baseline to the 6-month follow-up in the Intervention Arm versus the Control Arm.p-value: 0.981Tukey-Kramer
Primary

Change From Baseline Typical Weekly Drinking at 1 Month

At baseline and the 1-month follow-up, participants reported the typical quantity of standard alcohol drinks consumed on each day of the week during the past 30 days using the Daily Drinking Questionnaire. Quantity of drinks reported on each day of the week at baseline and 1-month were then summed (separately) to create a composite variable assessing typical weekly drinking at each time point. To compute the outcome, the 1-month measure of typical drinks per week was subtracted from the baseline measure of typical drinks per week such that a positive value indicates a decrease in consumption during this period and a negative value indicates an increase in consumption during this period.

Time frame: baseline, 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention AppChange From Baseline Typical Weekly Drinking at 1 Month1.67 typical alcohol drinks consumed per weekStandard Deviation 3.65
Control AppChange From Baseline Typical Weekly Drinking at 1 Month1.82 typical alcohol drinks consumed per weekStandard Deviation 3.77
Comparison: As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on weekly drinks. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 1-month follow-up in the Intervention Arm versus the Control Arm.p-value: 0.985Tukey-Kramer
Primary

Change From Baseline Typical Weekly Drinking at 6 Months

At baseline and the 6-month follow-up, participants reported the typical quantity of standard alcohol drinks consumed on each day of the week during the past 30 days using the Daily Drinking Questionnaire. Quantity of drinks reported on each day of the week at baseline and 1-month were then summed (separately) to create a composite variable assessing typical weekly drinking at each time point. To compute the outcome, the 6-month measure of typical drinks per week was subtracted from the baseline measure of typical drinks per week such that a positive value indicates a decrease in consumption during this period and a negative value indicates an increase in consumption during this period.

Time frame: baseline, 6 months

ArmMeasureValue (MEAN)Dispersion
Intervention AppChange From Baseline Typical Weekly Drinking at 6 Months2.31 typical alcohol drinks consumed per weekStandard Deviation 5.2
Control AppChange From Baseline Typical Weekly Drinking at 6 Months2.21 typical alcohol drinks consumed per weekStandard Deviation 4.44
Comparison: As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on weekly drinks. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 6-month follow-up in the Intervention Arm versus the Control Arm.p-value: 0.694Tukey-Kramer

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