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NCT04549454 · ClinicalTrials.gov registry record · NA
Parent Feedback Intervention Targeting Student Transitions and Alcohol Related Trajectories (+) Efficacy Study
A NA study, sponsored by Loyola Marymount University.
- Completed
- Registry status
- NA
- Development phase
- 266
- Enrollment target
NCT04549454: Completed NA study, sponsored by Loyola Marymount University.
NCT04549454 is a NA study that has completed, run by Loyola Marymount University. The registered enrollment target is 266 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04549454, a NA study, has completed, sponsored by Loyola Marymount University.
- COMPLETED
- Registry status
- NA
- Development phase
- 266 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- BEHAVIORAL FITSTART+ PBI
- BEHAVIORAL General Parenting Advice
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 266 participants |
| Start Date | 2021-07-22 |
| Est. Completion | 2022-03-22 |
| Phase | NA |
What the finished NCT04549454 record still lists
NCT04549454 is an interventional study that assigns participants to a tested intervention. The registered 266 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which FITSTART+ PBI is the first listed.
NCT04549454 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04549454 about?
NCT04549454 is a clinical study titled "Parent Feedback Intervention Targeting Student Transitions and Alcohol Related Trajectories (+) Efficacy Study". 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 negati...
What is the current status of trial NCT04549454?
This trial is currently completed. It is a NA study. The enrollment target is 266 participants. The study started on 2021-07-22. Estimated completion is 2022-03-22.
What interventions are being tested in trial NCT04549454?
The interventions under investigation include: FITSTART+ PBI (BEHAVIORAL), General Parenting Advice (BEHAVIORAL).
Who is sponsoring clinical trial NCT04549454?
This trial is sponsored by Loyola Marymount University, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04549454's enrollment target sits among peer trials
266 395th of 2000 higher than 1,606 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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