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

Primary Purpose

Alcohol Drinking, Alcohol Problem Drinking, Parenting

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FITSTART+ PBI
General Parenting Advice
Sponsored by
Loyola Marymount University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Drinking focused on measuring Parent Intervention, Alcohol Intervention, College Student Drinking

Eligibility Criteria

17 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Loyola Marymount

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention App

Control App

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 8, 2020
Last Updated
May 3, 2023
Sponsor
Loyola Marymount University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT04549454
Brief Title
Parent Feedback Intervention Targeting Student Transitions and Alcohol Related Trajectories (+) Efficacy Study
Acronym
FITSTART+
Official Title
Extension and Online Adaptation of the FITSTART Parent-based Intervention to Reduce Drinking Among First-year Students
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 22, 2021 (Actual)
Primary Completion Date
March 22, 2022 (Actual)
Study Completion Date
March 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loyola Marymount University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Alcohol Problem Drinking, Parenting
Keywords
Parent Intervention, Alcohol Intervention, College Student Drinking

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
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.
Allocation
Randomized
Enrollment
266 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention App
Arm Type
Experimental
Arm Description
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).
Arm Title
Control App
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
FITSTART+ PBI
Intervention Description
Personalized normative feedback on other parents behaviors + alcohol-specific parenting advice + general parenting advice
Intervention Type
Behavioral
Intervention Name(s)
General Parenting Advice
Intervention Description
General parenting advice
Primary Outcome Measure Information:
Title
Change From Baseline Typical Weekly Drinking at 1 Month
Description
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
Title
Change From Baseline Typical Weekly Drinking at 6 Months
Description
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
Title
Change From Baseline Frequency of Alcohol Consequences at 1 Month
Description
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
Title
Change From Baseline Frequency of Alcohol Consequences at 6 Months
Description
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
Title
Change From Baseline Quantity/Frequency/Peak Alcohol Use at 1 Month
Description
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
Title
Change From Baseline Quantity/Frequency/Peak Alcohol Use at 6 Months
Description
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
Title
Change From Baseline Heavy Episodic Drinking at 1 Month
Description
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
Title
Change From Baseline Heavy Episodic Drinking at 6 Months
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph W LaBrie, PhD
Organizational Affiliation
Loyola Marymount University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loyola Marymount
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study results will be reported in aggregate, so that individual participants will not be identifiable in any research reports or presentations of the proposed study. A de-identified dataset will be made available to researchers 1 year after the initial publication of results. This dataset will include participant demographics and outcome measures assessed at baseline and the follow-up surveys. A data dictionary will be provided.
IPD Sharing Time Frame
1 year following publication of results.
IPD Sharing Access Criteria
Study materials and data will be made available to the public on secure web portal.

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

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