Enhancing Quality in Protective Strategies

NCT04978129 | Completed Results

• 1 other identifier: 7R34AA028730-04
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Risk Behaviors; Risk Reduction Behavior

Outcome Measures

Primary Outcomes (17)

• Typical Number of Drinks Per Occasion

  Measures the typical number of drinks consumed per occasion.

  Baseline

• Typical Number of Drinks Per Occasion

  Measures the typical number of drinks consumed per occasion.

  2 Month

• Young Adult Alcohol Consequences Questionnaire

  The Young Adult Alcohol Consequences Questionnaire will asses consequences from drinking.

  Baseline

• Young Adult Alcohol Consequences Questionnaire

  The Young Adult Alcohol Consequences Questionnaire will asses consequences from drinking.

  2 Month

• Alcohol Protective Behavioral Strategies

  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. Protective Behavioral Strategies were assessed using the full Protective Behavioral Strategies Scale-20 (PBSS-20), which measures the frequency of using strategies to limit alcohol use and related consequences. The PBSS-20 consists of 20 items rated on a 6-point Likert-type scale (1 = Never to 6 = Always). Scores are averaged across items, with higher values indicating greater use of protective behavioral strategies (i.e., a more favorable outcome).

  Baseline

• Alcohol Protective Behavioral Strategies

  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. Protective Behavioral Strategies were assessed using the full Protective Behavioral Strategies Scale-20 (PBSS-20), which measures the frequency of using strategies to limit alcohol use and related consequences. The PBSS-20 consists of 20 items rated on a 6-point Likert-type scale (1 = Never to 6 = Always). Scores are averaged across items, with higher values indicating greater use of protective behavioral strategies (i.e., a more favorable outcome).

  2 Month

• Average Days Cannabis Use Past Two Months

  This measure will assess typical days cannabis was used the past two months.

  Baseline

• Average Days Cannabis Use Past Two Months

  This measure will assess typical days cannabis was used the past two months.

  2 Month

• Cannabis Protective Behavioral Strategies

  Cannabis Protective Behavioral Strategies were assessed using the Protective Behavioral Strategies for Marijuana Scale, a 26-item measure evaluating the frequency of strategies used to reduce cannabis use and related harm. Items are rated on a 6-point Likert scale (1 = Never to 6 = Always). Scores are averaged across items, with higher scores indicating greater use of protective behavioral strategies (i.e., a more favorable outcome).

  Baseline

• Cannabis Protective Behavioral Strategies

  Cannabis Protective Behavioral Strategies were assessed using the Protective Behavioral Strategies for Marijuana Scale, a 26-item measure evaluating the frequency of strategies used to reduce cannabis use and related harm. Items are rated on a 6-point Likert scale (1 = Never to 6 = Always). Scores are averaged across items, with higher scores indicating greater use of protective behavioral strategies (i.e., a more favorable outcome).

  2 Month

• Marijuana Consequences Questionnaire

  The Marijuana Consequences Questionnaire and a modified version will measure a broad range of negative cannabis consequences.

  Baseline

• Marijuana Consequences Questionnaire

  The Marijuana Consequences Questionnaire and a modified version will measure a broad range of negative cannabis consequences.

  2 Month

• Simultaneous Alcohol and Marijuana Use

  Questions regarding SAM use will be adapted from MTF.

  Baseline

• Simultaneous Alcohol and Marijuana Use

  Questions regarding SAM use will be adapted from MTF.

  2 Month

• Feasibility- Number of Participants Who Visited the Online Intervention

  The Number of Participants who Visited the Online Intervention

  2 Month

• Feasibility- Number of Online Modules Selected

  The number of modules participants in the intervention condition selected to view.

  Baseline

• Acceptability- System Usability Scale

  Scores on a measure of subjective assessments of usability (SUS) from participants in the intervention condition. Total score from 0 to 100 with higher scores indicating higher usability.

  Post-Intervention

Study Arms (2)

Online and Text Message Intervention

EXPERIMENTAL

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

Assessment Only Control

NO INTERVENTION

The assessment only 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.

Interventions

Online and Text Messaging Intervention BEHAVIORAL

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.

Online and Text Message Intervention

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-24
• Live in Texas
• Valid email address
• Own a cell phone with text messaging capabilities
• Okay with receiving messages
• Typically drink at least 2 days a week
• Typically use marijuana at least 2 days a week
• Report having at least 1 alcohol-related and 1 marijuana-related consequence in the past month
• Report being in contemplation or action stage based on readiness to change scale for alcohol or marijuana (i.e., not in precontemplation stage)
• If female, not pregnant or trying to become pregnant
• Not currently in treatment for alcohol or substance use
• 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) \[Phase II\]
• 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) \[Phase I\]

You may not qualify if:

• Unwillingness to participate
• Failure to provide consent
• Providing inconsistent responses (e.g., age), and
• Having already participated in the study as identified by overlap or consistency in email addresses, contact information, and demographics.

Sponsors & Collaborators

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

Study Sites (1)

University of North Texas Health Science Center

Fort Worth, Texas, 76107, United States

Location

Related Publications (42)

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  PMID: 35438642 DERIVED

MeSH Terms

Conditions

Health Risk Behaviors; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Limitations and Caveats

This is a small pilot trial designed to collect feasibility and acceptability information. All findings are based on self-report of alcohol and cannabis use.

Results Point of Contact

• Title: Melissa Lewis
• Organization: University of Texas at Arlington

Melissa.Lewis@uta.edu

817-272-9833

Study Officials

• Melissa A Lewis, PhD

  University of North Texas Health Science Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of School of Social Work

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 27, 2021
• Study Start: August 15, 2023
• Primary Completion: November 1, 2024
• Study Completion: April 1, 2025
• Last Updated: December 3, 2025
• Results First Posted: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)