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

NCT04549454 | Completed Results

• 2 other identifiers: LoyolaMarymountUR34AA026422
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Drinking; Alcohol Problem Drinking; Parenting

Keywords

Parent Intervention; Alcohol Intervention; College Student Drinking

Outcome Measures

Primary Outcomes (8)

• 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.

  baseline, 1 month

• 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.

  baseline, 6 months

• 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.

  baseline, 1 month

• 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.

  baseline, 6 months

• 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.

  baseline, 1 month

• 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.

  baseline, 6 months

• 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.

  baseline, 1 month

• 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.

  baseline, 6 months

Study Arms (2)

Intervention App

EXPERIMENTAL

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).

Behavioral: FITSTART+ PBI

Control App

PLACEBO COMPARATOR

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).

Behavioral: General Parenting Advice

Interventions

FITSTART+ PBI BEHAVIORAL

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

Intervention App

General Parenting Advice BEHAVIORAL

General parenting advice

Control App

Eligibility Criteria

• Age: 17 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Outside of the students age range

Sponsors & Collaborators

• Loyola Marymount University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Loyola Marymount

Los Angeles, California, 90045, United States

Location

MeSH Terms

Conditions

Alcohol Drinking; Alcoholism; Alcohol Drinking in College

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

This trial was conducted in the first on-campus semester post-Covid, and there were several restrictions regarding student life in effect. This likely affected student alcohol use by limiting social drinking events and willingness to engage in those events (depressing the levels of risky drinking). Thus, the ability to detect changes in drinking was likely to have been impacted.

Results Point of Contact

• Title: Dr. Bradley Trager, Research Scientist
• Organization: Loyola Marymount University

bradley.trager@lmu.edu

3103385238

Study Officials

• Joseph W LaBrie, PhD

  Loyola Marymount University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 16, 2020
• Study Start: July 22, 2021
• Primary Completion: March 22, 2022
• Study Completion: March 22, 2022
• Last Updated: June 1, 2023
• Results First Posted: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 1 year following publication of results.
• Access Criteria: Study materials and data will be made available to the public on secure web portal.

Locations

US (1)