Enhancing Quality in Protective Strategies (EQUIP)

August 28, 2023 updated by: Melissa Lewis, PhD, University of North Texas Health Science Center

Examining Motivations for and Quality of Alcohol and Marijuana Protective Behavior Strategy Use: Improving Prevention of Hazardous Young Adult Substance Use

The most successful young adult alcohol or marijuana interventions involve the provision of accurate, nonjudgmental personalized feedback, but notably the inclusion and effectiveness of protective behavioral strategies (PBS) content is inconsistent. Moreover, active components of brief interventions are not well understood, and findings have been inconclusive regarding whether PBS mediates intervention efficacy of college student personalized feedback interventions (PFIs), with only some studies showing evidence of mediation. One possible reason for these findings is that investigators often do not know young adults' motivations for using (or not using) PBS or the quality of PBS use across individuals or across drinking occasions. The proposed study will provide an in-depth examination of which PBS young adults are motivated to use (including implementation quality) and reasons that young adults may or may not use PBS. Understanding why young adults are choosing not to use PBS on specific occasions or do not engage in effective or high-quality PBS use on certain occasions has significant clinical implications, whereby interventions may need to spend more time increasing motivations to use PBS in an effective manner or work on reducing perceived barriers (i.e., reasons individuals are not using PBS). Clinicians may then be better able to work with young adults in various settings to reduce or prevent excessive alcohol and marijuana use and related consequences. The proposed research has high potential for making a substantial impact on the field and public health (particularly as more states permit legal access to marijuana for those over 21) as it will address a problem of high importance (alcohol and marijuana use) by being the first to develop and refine a PBS intervention that specifically focuses on motivations for alcohol and marijuana PBS use and non-use as well as quality of use, which is an overlooked aspect of current PBS-related intervention approaches. The development of more efficacious interventions to reduce the proportion of young adults who engage in excessive alcohol use and who experience consequences is a key priority of the NIAAA. Related, development of more effective interventions to reduce risk from marijuana use is an area of great importance for the NIDA.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The majority of young adults who use both alcohol and marijuana do so simultaneously. Simultaneous Alcohol and Marijuana (SAM) use is defined as using alcohol and marijuana at the same time so that their effects overlap. Individuals who engage in Concurrent Alcohol and Marijuana (CAM) use are often characterized as those who report both alcohol and marijuana use within the same time period (e.g., past month, past week). An increasing body of literature has documented CAM and SAM use on a given day among young adults. Event-level findings show SAM use is associated with increased risk for consequences, compared to marijuana use alone or CAM use. Given that the investigators' focus in this application is on daily-level substance use behaviors, the investigators define CAM use as using both substances on the same day, but not so that their effects overlap. Interventions should focus on reducing drinking as well as drinking that occurs in conjunction with marijuana use to provide a more comprehensive evaluation of intervention efficacy. The proposed research in this application will develop and test a novel online and text message (TM) protective behavioral strategies (PBS) intervention to reduce alcohol, marijuana, CAM, and SAM use and related negative consequences among young adults.

One way interventions could prevent or reduce alcohol- and marijuana-related consequences is by promoting the use of PBS, which are behaviors that individuals can use to limit consequences and/or reduce substance use. PBS are often incorporated into brief interventions or TM interventions in the form of skills training. Despite the empirical support for including PBS content in brief interventions, findings have been inconclusive regarding whether PBS mediate intervention efficacy among college students. One possible explanation is that skills-based PBS interventions prematurely focus on "how" to use PBS, but not "why" PBS might be used or used with high quality. Research is needed to determine motivations for when and why young adults may or may not decide to use PBS to reduce harm while using alcohol and/or marijuana, which can then enable investigators to better address these motivations in brief interventions. Research has yet to examine how alcohol and marijuana PBS use on a given day relates to an individual's use of alcohol alone or marijuana alone in comparison to CAM or SAM use. The proposed study will fill these critical gaps by identifying the extent to which motivations for PBS use and nonuse (marijuana or alcohol) and quality of PBS use (degree of effectiveness or degree of implementation) differ when using alcohol alone versus concurrently or simultaneously with marijuana. The overall goal of this research is to inform a pilot study of a newly developed alcohol and marijuana PBS intervention. The proposed research will (1) collect pilot data to establish feasibility and acceptability and test the interactive online and TM PBS intervention (baseline, 2-month) while also (2) collecting event-level data to examine daily-level associations among PBS motivation/quality, PBS use and non-use, alcohol and/or marijuana use, and negative consequences with a focus on how PBS may differ on CAM or SAM use days compared to alcohol-only days.

Aim 1: Examine motivations for alcohol and marijuana PBS use (and non-use of PBS) as well as quality of PBS use among young adults (ages 18-24) who use both alcohol and marijuana. The present study will conduct online focus groups (10 groups, N=10 individuals per group) and cognitive interviews (N=10) to determine why young adults use or do not use specific PBS related to alcohol and/or marijuana use. Focus groups will address how PBS use or motivations to avoid consequences may differ by gender (male, female, non-binary). Focus groups and cognitive interviews will discuss the level of quality in which PBS are used and various contexts in which PBS may or may not be used. Discussions will consider use of either substance alone on a given day as well as SAM or CAM use on a given day and will include ways in which the motivations and quality of PBS could be incorporated into an online and TM PBS intervention, as well as elicit feedback on mock intervention material. Using an exploratory sequential mixed methods design, an iterative process of focus groups and cognitive interviews will inform the development and delivery of the intervention to be tested in the pilot study (Aim 2). Aim 1 is not a clinical trial.

Aim 2: Conduct a pilot study with young adults (N=200; ages 18-24), who typically use alcohol and marijuana at least two days per week, to determine feasibility, acceptability, and preliminary effect sizes (to inform a future R01 application). Participants will be randomized to either the intervention or wait-list control. The intervention is a brief interactive online intervention focusing on self-selected alcohol and marijuana PBS messages and motives for using alcohol- and marijuana-related PBS and includes intervention content delivered via TMs three days a week (random day, Friday, Saturday) over eight consecutive weekends. All participants will report PBS use, motivations for PBS use (and non-use), quality of PBS use, readiness to change, and alcohol and marijuana use in morning surveys timed to occur the day after the intervention TMs for those in the intervention group. The proposed research in this application will provide an in-depth understanding of young adults' PBS use and has potential to develop a more efficacious intervention for these co-occurring or simultaneous alcohol and marijuana behaviors. Aim 2 is the clinical trial.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76107
        • Recruiting
        • University of North Texas Health Science Center
        • Contact:
          • Melissa A Lewis, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 24 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age 18-24
  2. Live in Texas
  3. Valid email address
  4. Own a cell phone with text messaging capabilities
  5. Okay with receiving messages
  6. Typically drink at least 2 days a week
  7. Typically use marijuana at least 2 days a week
  8. Report having at least 1 alcohol-related and 1 marijuana-related consequence in the past month
  9. Report being in contemplation or action stage based on readiness to change scale for alcohol or marijuana (i.e., not in precontemplation stage)
  10. If female, not pregnant or trying to become pregnant
  11. Not currently in treatment for alcohol or substance use
  12. Willing to participate in either online focus group or online cognitive interview (Phase I) or pilot study with daily morning surveys (Phase II), and willing to receive study notifications on phone (e.g., survey reminders) [Phase II]
  13. Their device must meet the system requirements to participate in the online focus group or cognitive interview (have iOS 8.0 or later, Android 4.0x, or later, or have another video-enabled device) [Phase I]

Exclusion Criteria:

  1. Not meeting inclusion criteria
  2. Unwillingness to participate
  3. Failure to provide consent
  4. Providing inconsistent responses (e.g., age), and
  5. Having already participated in the study as identified by overlap or consistency in email addresses, contact information, and demographics.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Online and Text Message Intervention
Participants randomized to the intervention will receive a link to the online intervention following baseline completion. The online and Text Message intervention, and its delivery, will be designed and adapted based on the results of the formative focus groups and cognitive interviews and is meant to be non-confrontational in tone, seeks to increase motivation to increase the quality use of PBS and decrease motivations for non-use of PBS. Intervention participants will receive personalized PBS Text Messages 3x per week (based on self-selections from the interactive online intervention) for 8 consecutive weeks timed to occur on a random weekday as well as Friday and Saturday.
Behavioral: Online and Text Messaging Intervention
The online and TM intervention, and its delivery, will be designed and adapted based on the results of the formative focus groups and cognitive interviews and is meant to be non-confrontational in tone, seeks to increase motivation to increase the quality use of PBS and decrease motivations for non-use of PBS.
No Intervention: Wait List Control
The wait-list control condition will not receive any intervention content during the 8-week period of data collection, but will complete baseline, 2-month, and daily surveys according to the same schedule as the intervention group in order to assess event-level PBS use, PBS non-use, alcohol and marijuana use, CAM and SAM use, and related consequences for up to 24 days over an 8-week period. All wait-list control participants will receive the intervention at the end of the 8-week period of data collection for the pilot study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Daily Drinking Questionnaire
Time Frame: Change from Baseline measurement at 2 months
The Daily Drinking Questionnaire (Collins, Parks, & Marlatt, 1985) measures the quantity and frequency of alcohol use by asking students to estimate the typical number of drinks consumed on each day of the week, averaged over the previous 3 months.
Change from Baseline measurement at 2 months
Change in Young Adult Alcohol Consequences Questionnaire
Time Frame: Change from Baseline measurement at 2 months
The Young Adult Alcohol Consequences Questionnaire (α=.79; Read et al., 2006) will asses consequences from drinking.
Change from Baseline measurement at 2 months
Change in Alcohol Protective Behavioral Strategies
Time Frame: Change from Baseline measurement at 2 months
Alcohol Protective Behavioral Strategies (i.e., tips and strategies used to reduce harm when drinking) will be assessed with the Protective Behavioral Strategies Survey-20 (PBSS-20; α=.63-.81; Treloar et al., 2015).
Change from Baseline measurement at 2 months
Change in Motivations for alcohol Protective Behavioral Strategies use and non-use
Time Frame: Change from Baseline measurement at 2 months
Motivations for alcohol Protective Behavioral Strategies use and non-use survey (i.e., tips and strategies used to reduce harm when drinking) will be used (α=.80; Litt & Lewis, 2016; Bravo et al., 2018).
Change from Baseline measurement at 2 months
Change in Daily Marijuana Use Questionnaire
Time Frame: Change from Baseline measurement at 2 months
A parallel Daily Drinking Questionnaire measure will be asked for marijuana assessing typical days used and typical number of hours high each day (α=.97, Lee et al., 2013).
Change from Baseline measurement at 2 months
Change in Marijuana Protective Behavioral Strategies
Time Frame: Change from Baseline measurement at 2 months
Marijuana Protective Behavioral Strategies (i.e., tips and strategies used to reduce harm when using marijuana) will be assessed using the Protective Behavioral Strategies for Marijuana Scale (PBSM-36; Pedersen et al., 2017; α=.93).
Change from Baseline measurement at 2 months
Change in Motivations for marijuana Protective Behavioral Strategies use and non-use
Time Frame: Change from Baseline measurement at 2 months
Motivations for marijuana Protective Behavioral Strategies use and non-use survey (i.e., tips and strategies used to reduce harm when using marijuana) will be assessed using parallel items to the alcohol protective behavioral strategies motivations measure (Litt & Lewis, 2016; Bravo et al., 2018).
Change from Baseline measurement at 2 months
Change in Rutgers Marijuana Problem Index
Time Frame: From date of randomization until study completion, up to 2 months. This measure will be administered using daily surveys sent on the day following intervention TMs, which are sent on Friday, Saturday, and a randomly chosen weekday for up to 8 weeks.
The Rutgers Marijuana Problem Index (White et al., 2005) will assess marijuana consequences, selecting acute items appropriate for daily-level measurement.
From date of randomization until study completion, up to 2 months. This measure will be administered using daily surveys sent on the day following intervention TMs, which are sent on Friday, Saturday, and a randomly chosen weekday for up to 8 weeks.
Change in Protective Behavioral Strategy use and quality the previous day
Time Frame: From date of randomization until study completion, up to 2 months. This measure will be administered using daily surveys sent on the day following intervention TMs, which are sent on Friday, Saturday, and a randomly chosen weekday for up to 8 weeks.
PBS use and quality the previous day will be assessed by having participants report which, if any, alcohol and/or marijuana PBS they used the previous day, and for those they report using, how well they implemented the PBS (i.e., quality) and how helpful they perceived the strategy to be.
From date of randomization until study completion, up to 2 months. This measure will be administered using daily surveys sent on the day following intervention TMs, which are sent on Friday, Saturday, and a randomly chosen weekday for up to 8 weeks.
Change in Simultaneous Alcohol and Marijuana Use
Time Frame: Change from date of randomization until study completion, up to 2 months. This measure will be administered using daily surveys sent the day after intervention TMs, which are sent on Friday, Saturday, and a randomly chosen weekday for up to 8 weeks.
Questions regarding SAM use will be adapted from MTF (Johnston et al., 2015).
Change from date of randomization until study completion, up to 2 months. This measure will be administered using daily surveys sent the day after intervention TMs, which are sent on Friday, Saturday, and a randomly chosen weekday for up to 8 weeks.
Change in Concurrent Alcohol and Marijuana Use
Time Frame: Change from date of randomization until study completion, up to 2 months. This measure will be administered using daily surveys sent the day after intervention TMs, which are sent on Friday, Saturday, and a randomly chosen weekday for up to 8 weeks.
Concurrent Alcohol and Marijuana Use: Concurrent Alcohol and Marijuana Use is determined from the alcohol and marijuana measures (i.e., endorsement of both alcohol and marijuana use within the same timeframe; Lee et al., 2013).
Change from date of randomization until study completion, up to 2 months. This measure will be administered using daily surveys sent the day after intervention TMs, which are sent on Friday, Saturday, and a randomly chosen weekday for up to 8 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Texas Health Science Center

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Melissa A Lewis, PhD, University of North Texas Health Science Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

June 24, 2021

First Submitted That Met QC Criteria

July 15, 2021

First Posted (Actual)

July 27, 2021

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • R34AA028730 (U.S. NIH Grant/Contract)
  • 1R34AA028730-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

A select number of researchers will have access to unidentified participant data at the close of the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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