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FITSTART+ Parent-Based Intervention Efficacy Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04549454
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Joseph LaBrie, Loyola Marymount University

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.

Condition or disease Intervention/treatment Phase
Alcohol Drinking Alcohol Problem Drinking Parenting Behavioral: FITSTART+ PBI Behavioral: General Parenting Advice Not Applicable

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 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 parent-student dyads recruited from Loyola Marymount University (LMU). Eligible dyads are those that include a parent of incoming LMU first-year student. The parent needs to have downloaded and registered the app and the student needs to have completed a baseline survey prior to the parent receiving the app (end of November). Parents will be invited to download the intervention/control app two months prior to their students arrival on campus in the Spring. To examine the sustained effects of the intervention, students will complete two baseline surveys, one in August (pre-matriculation) and another November (preceding parent intervention), and two follow-up surveys, approximately 1-month and 3-months after the students arrive on campus in the spring. (First-year students were not permitted to move onto campus during the Fall semester due to COVID-19.)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Primary Purpose: Prevention
Official Title: Extension and Online Adaptation of the FITSTART Parent-based Intervention to Reduce Drinking Among First-year Students
Actual Study Start Date : August 18, 2020
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting

Arm Intervention/treatment
Experimental: Intervention App
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
Personalized normative feedback on other parents behaviors + alcohol-specific parenting advice + general parenting advice

Placebo Comparator: Control App
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
General parenting advice




Primary Outcome Measures :
  1. Change from Baseline Daily Drinking at 1 Month [ Time Frame: baseline, 1 month ]
    Assesses number of drinks consumed during an average week over the past month

  2. Change from Baseline Daily Drinking at 3 Months [ Time Frame: baseline, 3 months ]
    Assesses number of drinks consumed during an average week over the past month.

  3. Change from Baseline Frequency of Alcohol Consequences at 1 Month [ Time Frame: baseline, 1 month ]
    Assesses reported frequency of negative alcohol outcomes over the past month

  4. Change from Baseline Frequency of Alcohol Consequences at 3 Months [ Time Frame: baseline, 3 months ]
    Assesses reported frequency of negative alcohol outcomes over the past month

  5. Change from Baseline Quantity/Frequency/Peak Alcohol Use at 1 Month [ Time Frame: baseline, 1 month ]
    Assesses frequency and quantity of alcohol consumption over the past month

  6. Change from Baseline Quantity/Frequency/Peak Alcohol Use at 3 Months [ Time Frame: baseline, 3 months ]
    Assesses frequency and quantity of alcohol consumption over the past month

  7. Change from Baseline heavy episodic drinking at 1 Month [ Time Frame: baseline, 1 month ]
    Assesses frequency heavy episodic drinking events over the past month

  8. Change from Baseline heavy episodic drinking at 3 Months [ Time Frame: baseline, 3 months ]
    Assesses frequency heavy episodic drinking events over the past month



Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04549454


Contacts
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Contact: Bradley M Trager, PhD 3103383701 bradley.trager@lmu.edu

Locations
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United States, California
Loyola Marymount Recruiting
Los Angeles, California, United States, 90045
Contact: Bradley M Trager, PhD    310-338-3701    bradley.trager@lmu.edu   
Contact: Joseph W LaBrie, PhD    3103385238    jlabrie@lmu.edu   
Principal Investigator: Joseph W LaBrie, PhD         
Sponsors and Collaborators
Loyola Marymount University
Investigators
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Principal Investigator: Joseph W LaBrie, PhD Loyola Marymount University
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Responsible Party: Dr. Joseph LaBrie, Professor of Psychology, Loyola Marymount University
ClinicalTrials.gov Identifier: NCT04549454    
Other Study ID Numbers: LoyolaMarymountU
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Joseph LaBrie, Loyola Marymount University:
Parent Intervention
Alcohol Intervention
College Student Drinking
Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders