EQUIP: Enhancing Quality in Protective Strategies

• Sponsor: University of North Texas Health Science Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04978129
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 14
• Patients Per Site Per Month: 14.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Health Risk Behaviors; Risk Reduction Behavior	Behavioral: Online and Text Messaging Intervention	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Examining Motivations for and Quality of Alcohol and Marijuana Protective Behavior Strategy Use: Improving Prevention of Hazardous Young Adult Substance Use
• Anticipated Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Mar 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in Daily Drinking Questionnaire [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.

2. Change in Young Adult Alcohol Consequences Questionnaire [Change from Baseline measurement at 2 months]

   The Young Adult Alcohol Consequences Questionnaire (α=.79; Read et al., 2006) will asses consequences from drinking.

3. Change in Alcohol Protective Behavioral Strategies [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).

4. Change in Motivations for alcohol Protective Behavioral Strategies use and non-use [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).

5. Change in Daily Marijuana Use Questionnaire [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).

6. Change in Marijuana Protective Behavioral Strategies [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).

7. Change in Motivations for marijuana Protective Behavioral Strategies use and non-use [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).

8. Change in Rutgers Marijuana Problem Index [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.

9. Change in Protective Behavioral Strategy use and quality the previous day [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.

10. Change in Simultaneous Alcohol and Marijuana Use [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).

11. Change in Concurrent Alcohol and Marijuana Use [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 24 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of North Texas Health Science Center	Fort Worth	Texas	United States	76107

Sponsors and Collaborators

• University of North Texas Health Science Center
• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

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• Responsible Party: Melissa Lewis, PhD, Professor of Health Behavior and Health Systems, University of North Texas Health Science Center
• ClinicalTrials.gov Identifier: NCT04978129
• Other Study ID Numbers: R34AA028730; 1R34AA028730-01A1
• First Posted: Jul 27, 2021
• Last Update Posted: Feb 28, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 28, 2022