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N/A N=266 Randomized Single-blind Prevention

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

Alcohol Drinking · Alcohol Problem Drinking · Parenting

Enrolled (actual)
266
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Change From Baseline Typical Weekly Drinking at 1 Month — 1.67; 1.82 typical alcohol drinks consumed per week — p=.985

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
FITSTART+ PBI (Behavioral); General Parenting Advice (Behavioral)
Age
Pediatric, Adult · 17+ yrs
Sex
All
Sponsor
Loyola Marymount University
Primary completion
Mar 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline Typical Weekly Drinking at 1 Month
1.67; 1.82 .985
PRIMARY
Change From Baseline Typical Weekly Drinking at 6 Months
2.31; 2.21 .694
PRIMARY
Change From Baseline Frequency of Alcohol Consequences at 1 Month
0.24; 0.28 .889
PRIMARY
Change From Baseline Frequency of Alcohol Consequences at 6 Months
.52; .73 .582
PRIMARY
Change From Baseline Quantity/Frequency/Peak Alcohol Use at 1 Month
.91; .98 .523
PRIMARY
Change From Baseline Quantity/Frequency/Peak Alcohol Use at 6 Months
1.54; 1.36 .981
PRIMARY
Change From Baseline Heavy Episodic Drinking at 1 Month
.41; .47 .889
PRIMARY
Change From Baseline Heavy Episodic Drinking at 6 Months
.67; .56 .582

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04549454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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