Clinical trial NCT04549454: Parent Feedback Intervention Targeting Student Transitions and Alcohol Related Trajectories (+) Efficacy Study
Official title: Extension and Online Adaptation of the FITSTART Parent-based Intervention to Reduce Drinking Among First-year Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Alcohol Problem Drinking
Parenting
Keywords: Parent Intervention
Alcohol Intervention
College Student Drinking
Lead sponsor: Loyola Marymount University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2020-09-16
Enrollment: 266
Sex: ALL
Minimum age (years): 17
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change From Baseline Typical Weekly Drinking at 1 Month
timeFrame: baseline, 1 month
measure: Change From Baseline Typical Weekly Drinking at 6 Months
timeFrame: baseline, 6 months
measure: Change From Baseline Frequency of Alcohol Consequences at 1 Month
timeFrame: baseline, 1 month
measure: Change From Baseline Frequency of Alcohol Consequences at 6 Months
timeFrame: baseline, 6 months
measure: Change From Baseline Quantity/Frequency/Peak Alcohol Use at 1 Month
timeFrame: baseline, 1 month
measure: Change From Baseline Quantity/Frequency/Peak Alcohol Use at 6 Months
timeFrame: baseline, 6 months
measure: Change From Baseline Heavy Episodic Drinking at 1 Month
timeFrame: baseline, 1 month
measure: Change From Baseline Heavy Episodic Drinking at 6 Months
timeFrame: baseline, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Loyola Marymount
state: California
Study officials:
affiliation: Loyola Marymount University
name: Joseph W LaBrie, PhD
role: PRINCIPAL_INVESTIGATOR
References: