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Promoting Maintenance of Change Following Brief Intervention for Alcohol Use

Primary Purpose

Alcohol Drinking in College

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Parent handbook
Coping with negative emotions
Problem-solving risky situations
Recovering from slips
Sponsored by
University of Massachusetts, Amherst
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Drinking in College

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Student participants must meet the following eligibility criteria: Currently enrolled student at the University of Massachusetts Amherst First time violator of the university alcohol policy Mandated to complete the Brief Alcohol Screening and Intervention of College Students (BASICS) intervention Minimum age 18 Parent participants must meet the following eligibility criteria: • The parent or guardian of students who meet all of the student participant criteria Exclusion Criteria: • None.

Sites / Locations

    Arms of the Study

    Arm 1

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    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm 9

    Arm 10

    Arm 11

    Arm 12

    Arm 13

    Arm 14

    Arm 15

    Arm 16

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    No Intervention

    Arm Label

    Coping with emotions, Parent handbook, Problem-solving risky situations, and Recovering from slips

    Coping with negative emotions, Parent handbook , and Problem-solving for risky situations

    Coping with negative emotions, Parent handbook , and Recovering from slips

    Coping with negative emotions and Parent handbook

    Coping with negative emotions, Problem-solving for risky situations , and Recovering from slips

    Coping with negative emotions and Problem-solving for risky situations

    Coping with negative emotions and Recovering from slips

    Coping with negative emotions

    Parent handbook , Problem-solving for risky situations , and Recovering from slips

    Parent handbook and Problem-solving for risky situations

    Parent handbook and Recovering from slips

    Parent handbook

    Problem-solving for risky situations and Recovering from slips

    Problem-solving for risky situations

    Recovering from slips

    Assessment only control condition

    Arm Description

    Participants will learn to use techniques based in mindfulness as a means for coping with negative emotions. The participants' parent(s) will also receive a handbook that encourages communication with their child about alcohol use. Participants will be prompted to identify both barriers to reducing their alcohol use and protective strategies for navigating those barriers. To improve their confidence to resume moderate drinking after having a heavy drinking episode, participants will be presented with narratives from other students who successfully resumed moderate drinking after a heavy drinking episode. Students will also be prompted to identify alcohol free activities that they enjoy and can engage in after experiencing a heavy drinking episode.

    Participants will learn to use techniques based in mindfulness as a means for coping with negative emotions. The participants' parent(s) will also receive a handbook that encourages communication with their child about alcohol use. Participants will be prompted to identify both barriers to reducing their alcohol use and protective strategies for navigating those barriers.

    Participants will learn to use techniques based in mindfulness as a means for coping with negative emotions. The participants' parent(s) will also receive a handbook that encourages communication with their child about alcohol use. To improve their confidence to resume moderate drinking after having a heavy drinking episode, participants will be presented with narratives from other students who successfully resumed moderate drinking after a heavy drinking episode. Students will also be prompted to identify alcohol free activities that they enjoy and can engage in after experiencing a heavy drinking episode.

    Participants will learn to use techniques based in mindfulness as a means for coping with negative emotions. The participants' parent(s) will also receive a handbook that encourages communication with their child about alcohol use.

    Participants will learn to use techniques based in mindfulness as a means for coping with negative emotions. Participants will be prompted to identify both barriers to reducing their alcohol use and protective strategies for navigating those barriers. To improve their confidence to resume moderate drinking after having a heavy drinking episode, participants will be presented with narratives from other students who successfully resumed moderate drinking after a heavy drinking episode. Students will also be prompted to identify alcohol free activities that they enjoy and can engage in after experiencing a heavy drinking episode.

    Participants will learn to use techniques based in mindfulness as a means for coping with negative emotions. Participants will be prompted to identify both barriers to reducing their alcohol use and protective strategies for navigating those barriers.

    Participants will learn to use techniques based in mindfulness as a means for coping with negative emotions. To improve their confidence to resume moderate drinking after having a heavy drinking episode, participants will be presented with narratives from other students who successfully resumed moderate drinking after a heavy drinking episode. Students will also be prompted to identify alcohol free activities that they enjoy and can engage in after experiencing a heavy drinking episode.

    Participants will learn to use techniques based in mindfulness as a means for coping with negative emotions.

    The participants' parent(s) will receive a handbook that encourages communication with their child about alcohol use. Participants will be prompted to identify both barriers to reducing their alcohol use and protective strategies for navigating those barriers. To improve their confidence to resume moderate drinking after having a heavy drinking episode, participants will be presented with narratives from other students who successfully resumed moderate drinking after a heavy drinking episode. Students will also be prompted to identify alcohol free activities that they enjoy and can engage in after experiencing a heavy drinking episode.

    The participants' parent(s) will receive a handbook that encourages communication with their child about alcohol use. Participants will be prompted to identify both barriers to reducing their alcohol use and protective strategies for navigating those barriers. To improve their confidence to resume moderate drinking after having a heavy drinking episode, participants will be presented with narratives from other students who successfully resumed moderate drinking after a heavy drinking episode. Students will also be prompted to identify alcohol free activities that they enjoy and can engage in after experiencing a heavy drinking episode.

    The participants' parent(s) will receive a handbook that encourages communication with their child about alcohol use. To improve their confidence to resume moderate drinking after having a heavy drinking episode, participants will be presented with narratives from other students who successfully resumed moderate drinking after a heavy drinking episode. Students will also be prompted to identify alcohol free activities that they enjoy and can engage in after experiencing a heavy drinking episode.

    The participants' parent(s) will receive a handbook that encourages communication with their child about alcohol use.

    Participants will be prompted to identify both barriers to reducing their alcohol use and protective strategies for navigating those barriers. To improve their confidence to resume moderate drinking after having a heavy drinking episode, participants will be presented with narratives from other students who successfully resumed moderate drinking after a heavy drinking episode. Students will also be prompted to identify alcohol free activities that they enjoy and can engage in after experiencing a heavy drinking episode.

    Participants will be prompted to identify both barriers to reducing their alcohol use and protective strategies for navigating those barriers.

    To improve their confidence to resume moderate drinking after having a heavy drinking episode, participants will be presented with narratives from other students who successfully resumed moderate drinking after a heavy drinking episode. Students will also be prompted to identify alcohol free activities that they enjoy and can engage in after experiencing a heavy drinking episode.

    Participants in this condition will complete assessments but will not receive any additional intervention content.

    Outcomes

    Primary Outcome Measures

    Drinking Intentions
    Drinking intentions will be assessed using a modified version of the daily drinking questionnaire (Young, Rodriguez, & Neighbors, 2013). Participants will complete a 7-day grid, indicating how many drinks they intend to consume on a typical Sunday, Monday, etc. in the next month. Responses will be summed to capture intentions for typical weekly drinking.
    Coping motives
    Thirteen items will be assessed capturing drinking to cope with both anxiety and depression (Cooper, 1994; Grant, Stewart, O'Connor, Blackwell, & Conrod, 2007). Items assess using alcohol "to reduce my anxiety" or "to forget my worries" and are rated on a 1 (almost never/never) to 5 (almost always/always) scale. Items will be averaged to form separate scale scores for coping with anxiety and coping with depression. The measure has been shown to be reliable among college students.
    Parent-student communication
    Five items will assess parents' intentions for engaging in general communication with their child about school, social activities, personal issues, romantic relationships, and personal problems (Barnes, Hoffman, Welte, Farrell, & Dintcheff, 2006). Items are rated on a 1 (not at all) to 7 (frequently) scale and averaged to form a scale score. This measure has been shown to be responsive to a parent-based intervention and reliable among college students (Testa, Hoffman, Livingston, & Turrisi, 2010).
    Maintenance self-efficacy
    Maintenance self-efficacy will be assessed with the 8-item Brief Situational Confidence Questionnaire (BSCQ; Breslin, Sobell, Sobell, & Agrawal, 2000). Student participants will indicate confidence in their ability to resist drinking heavily in eight situations, such as during pleasant times with others, (e.g., celebrating with a friend). Items are rated from 0% (not at all confident) to 100% (completely confident) and averaged to form a scale score. The measure is reliable and detects intervention-induced change among non-dependent young adults (Magill et al., 2017).
    Recovery self-efficacy
    Recovery self-efficacy will be assessed with nine items adapted from previous research (Luszczynska, Mazurkiewicz, Ziegelmann, & Schwarzer, 2007). One item will assess overall recovery self-efficacy and eight will mirror the situations used in the BSCQ . Items include, "I am confident that I could resume moderate drinking, even if I drank heavily because I was enjoying pleasant times with others." Like the BSCQ, items will be rated from 0% (not at all confident) to 100% (completely confident).

    Secondary Outcome Measures

    Full Information

    First Posted
    January 25, 2023
    Last Updated
    February 7, 2023
    Sponsor
    University of Massachusetts, Amherst
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05712382
    Brief Title
    Promoting Maintenance of Change Following Brief Intervention for Alcohol Use
    Official Title
    Promoting Maintenance of Change Following Brief Intervention for Alcohol Use
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2025 (Anticipated)
    Primary Completion Date
    May 2026 (Anticipated)
    Study Completion Date
    May 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Massachusetts, Amherst

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    All students who enroll in the study will receive an efficacious counselor-delivered brief motivational intervention. The intervention is based in principles of motivational interviewing. Students complete a baseline assessment on their alcohol use and alcohol-related consequences. During the hour-long session, the counselor uses information from the baseline assessment to compare the student's level of alcohol consumption to that of peers at the same university, discuss choices that may lead to experiencing negative consequences, and provide opportunities for the student to set goals for risk reduction. This study will develop and pilot a maintenance enhancement intervention. The intervention is expected to consist of four components, for example: (1) Student participants may learn to use techniques based in mindfulness to cope with negative emotions. (2) Student participants may identify barriers to reducing their alcohol use and identify protective strategies for navigating those barriers. (3) Student participants may be presented with narratives from other students who successfully resumed moderate drinking after a heavy drinking episode. Students may also be prompted to identify alcohol free activities that they enjoy and can engage in after experiencing a heavy drinking episode. (4) Parents may also receive a handbook encouraging communication with their student about alcohol use.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Drinking in College

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    160 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Coping with emotions, Parent handbook, Problem-solving risky situations, and Recovering from slips
    Arm Type
    Active Comparator
    Arm Description
    Participants will learn to use techniques based in mindfulness as a means for coping with negative emotions. The participants' parent(s) will also receive a handbook that encourages communication with their child about alcohol use. Participants will be prompted to identify both barriers to reducing their alcohol use and protective strategies for navigating those barriers. To improve their confidence to resume moderate drinking after having a heavy drinking episode, participants will be presented with narratives from other students who successfully resumed moderate drinking after a heavy drinking episode. Students will also be prompted to identify alcohol free activities that they enjoy and can engage in after experiencing a heavy drinking episode.
    Arm Title
    Coping with negative emotions, Parent handbook , and Problem-solving for risky situations
    Arm Type
    Active Comparator
    Arm Description
    Participants will learn to use techniques based in mindfulness as a means for coping with negative emotions. The participants' parent(s) will also receive a handbook that encourages communication with their child about alcohol use. Participants will be prompted to identify both barriers to reducing their alcohol use and protective strategies for navigating those barriers.
    Arm Title
    Coping with negative emotions, Parent handbook , and Recovering from slips
    Arm Type
    Active Comparator
    Arm Description
    Participants will learn to use techniques based in mindfulness as a means for coping with negative emotions. The participants' parent(s) will also receive a handbook that encourages communication with their child about alcohol use. To improve their confidence to resume moderate drinking after having a heavy drinking episode, participants will be presented with narratives from other students who successfully resumed moderate drinking after a heavy drinking episode. Students will also be prompted to identify alcohol free activities that they enjoy and can engage in after experiencing a heavy drinking episode.
    Arm Title
    Coping with negative emotions and Parent handbook
    Arm Type
    Active Comparator
    Arm Description
    Participants will learn to use techniques based in mindfulness as a means for coping with negative emotions. The participants' parent(s) will also receive a handbook that encourages communication with their child about alcohol use.
    Arm Title
    Coping with negative emotions, Problem-solving for risky situations , and Recovering from slips
    Arm Type
    Active Comparator
    Arm Description
    Participants will learn to use techniques based in mindfulness as a means for coping with negative emotions. Participants will be prompted to identify both barriers to reducing their alcohol use and protective strategies for navigating those barriers. To improve their confidence to resume moderate drinking after having a heavy drinking episode, participants will be presented with narratives from other students who successfully resumed moderate drinking after a heavy drinking episode. Students will also be prompted to identify alcohol free activities that they enjoy and can engage in after experiencing a heavy drinking episode.
    Arm Title
    Coping with negative emotions and Problem-solving for risky situations
    Arm Type
    Active Comparator
    Arm Description
    Participants will learn to use techniques based in mindfulness as a means for coping with negative emotions. Participants will be prompted to identify both barriers to reducing their alcohol use and protective strategies for navigating those barriers.
    Arm Title
    Coping with negative emotions and Recovering from slips
    Arm Type
    Active Comparator
    Arm Description
    Participants will learn to use techniques based in mindfulness as a means for coping with negative emotions. To improve their confidence to resume moderate drinking after having a heavy drinking episode, participants will be presented with narratives from other students who successfully resumed moderate drinking after a heavy drinking episode. Students will also be prompted to identify alcohol free activities that they enjoy and can engage in after experiencing a heavy drinking episode.
    Arm Title
    Coping with negative emotions
    Arm Type
    Active Comparator
    Arm Description
    Participants will learn to use techniques based in mindfulness as a means for coping with negative emotions.
    Arm Title
    Parent handbook , Problem-solving for risky situations , and Recovering from slips
    Arm Type
    Active Comparator
    Arm Description
    The participants' parent(s) will receive a handbook that encourages communication with their child about alcohol use. Participants will be prompted to identify both barriers to reducing their alcohol use and protective strategies for navigating those barriers. To improve their confidence to resume moderate drinking after having a heavy drinking episode, participants will be presented with narratives from other students who successfully resumed moderate drinking after a heavy drinking episode. Students will also be prompted to identify alcohol free activities that they enjoy and can engage in after experiencing a heavy drinking episode.
    Arm Title
    Parent handbook and Problem-solving for risky situations
    Arm Type
    Active Comparator
    Arm Description
    The participants' parent(s) will receive a handbook that encourages communication with their child about alcohol use. Participants will be prompted to identify both barriers to reducing their alcohol use and protective strategies for navigating those barriers. To improve their confidence to resume moderate drinking after having a heavy drinking episode, participants will be presented with narratives from other students who successfully resumed moderate drinking after a heavy drinking episode. Students will also be prompted to identify alcohol free activities that they enjoy and can engage in after experiencing a heavy drinking episode.
    Arm Title
    Parent handbook and Recovering from slips
    Arm Type
    Active Comparator
    Arm Description
    The participants' parent(s) will receive a handbook that encourages communication with their child about alcohol use. To improve their confidence to resume moderate drinking after having a heavy drinking episode, participants will be presented with narratives from other students who successfully resumed moderate drinking after a heavy drinking episode. Students will also be prompted to identify alcohol free activities that they enjoy and can engage in after experiencing a heavy drinking episode.
    Arm Title
    Parent handbook
    Arm Type
    Active Comparator
    Arm Description
    The participants' parent(s) will receive a handbook that encourages communication with their child about alcohol use.
    Arm Title
    Problem-solving for risky situations and Recovering from slips
    Arm Type
    Active Comparator
    Arm Description
    Participants will be prompted to identify both barriers to reducing their alcohol use and protective strategies for navigating those barriers. To improve their confidence to resume moderate drinking after having a heavy drinking episode, participants will be presented with narratives from other students who successfully resumed moderate drinking after a heavy drinking episode. Students will also be prompted to identify alcohol free activities that they enjoy and can engage in after experiencing a heavy drinking episode.
    Arm Title
    Problem-solving for risky situations
    Arm Type
    Active Comparator
    Arm Description
    Participants will be prompted to identify both barriers to reducing their alcohol use and protective strategies for navigating those barriers.
    Arm Title
    Recovering from slips
    Arm Type
    Active Comparator
    Arm Description
    To improve their confidence to resume moderate drinking after having a heavy drinking episode, participants will be presented with narratives from other students who successfully resumed moderate drinking after a heavy drinking episode. Students will also be prompted to identify alcohol free activities that they enjoy and can engage in after experiencing a heavy drinking episode.
    Arm Title
    Assessment only control condition
    Arm Type
    No Intervention
    Arm Description
    Participants in this condition will complete assessments but will not receive any additional intervention content.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Parent handbook
    Intervention Description
    Handbook motivating parents to discuss alcohol use with their college student.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Coping with negative emotions
    Intervention Description
    Mindfulness-based techniques are taught to improve ability to cope with negative emotions.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Problem-solving risky situations
    Intervention Description
    Identifying and planning for barriers to change are encouraged.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Recovering from slips
    Intervention Description
    Peer and personalized techniques are discussed to facilitate resumption of moderate drinking after a heavy drinking episode.
    Primary Outcome Measure Information:
    Title
    Drinking Intentions
    Description
    Drinking intentions will be assessed using a modified version of the daily drinking questionnaire (Young, Rodriguez, & Neighbors, 2013). Participants will complete a 7-day grid, indicating how many drinks they intend to consume on a typical Sunday, Monday, etc. in the next month. Responses will be summed to capture intentions for typical weekly drinking.
    Time Frame
    Immediate post-test
    Title
    Coping motives
    Description
    Thirteen items will be assessed capturing drinking to cope with both anxiety and depression (Cooper, 1994; Grant, Stewart, O'Connor, Blackwell, & Conrod, 2007). Items assess using alcohol "to reduce my anxiety" or "to forget my worries" and are rated on a 1 (almost never/never) to 5 (almost always/always) scale. Items will be averaged to form separate scale scores for coping with anxiety and coping with depression. The measure has been shown to be reliable among college students.
    Time Frame
    Immediate post-test
    Title
    Parent-student communication
    Description
    Five items will assess parents' intentions for engaging in general communication with their child about school, social activities, personal issues, romantic relationships, and personal problems (Barnes, Hoffman, Welte, Farrell, & Dintcheff, 2006). Items are rated on a 1 (not at all) to 7 (frequently) scale and averaged to form a scale score. This measure has been shown to be responsive to a parent-based intervention and reliable among college students (Testa, Hoffman, Livingston, & Turrisi, 2010).
    Time Frame
    Immediate post-test
    Title
    Maintenance self-efficacy
    Description
    Maintenance self-efficacy will be assessed with the 8-item Brief Situational Confidence Questionnaire (BSCQ; Breslin, Sobell, Sobell, & Agrawal, 2000). Student participants will indicate confidence in their ability to resist drinking heavily in eight situations, such as during pleasant times with others, (e.g., celebrating with a friend). Items are rated from 0% (not at all confident) to 100% (completely confident) and averaged to form a scale score. The measure is reliable and detects intervention-induced change among non-dependent young adults (Magill et al., 2017).
    Time Frame
    Immediate post-test
    Title
    Recovery self-efficacy
    Description
    Recovery self-efficacy will be assessed with nine items adapted from previous research (Luszczynska, Mazurkiewicz, Ziegelmann, & Schwarzer, 2007). One item will assess overall recovery self-efficacy and eight will mirror the situations used in the BSCQ . Items include, "I am confident that I could resume moderate drinking, even if I drank heavily because I was enjoying pleasant times with others." Like the BSCQ, items will be rated from 0% (not at all confident) to 100% (completely confident).
    Time Frame
    Immediate post-test

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Student participants must meet the following eligibility criteria: Currently enrolled student at the University of Massachusetts Amherst First time violator of the university alcohol policy Mandated to complete the Brief Alcohol Screening and Intervention of College Students (BASICS) intervention Minimum age 18 Parent participants must meet the following eligibility criteria: • The parent or guardian of students who meet all of the student participant criteria Exclusion Criteria: • None.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Allecia Reid, PhD
    Phone
    413-545-0264
    Email
    aereid@umass.edu

    12. IPD Sharing Statement

    Learn more about this trial

    Promoting Maintenance of Change Following Brief Intervention for Alcohol Use

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