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Social Media Intervention for Cannabis Use in Emerging Adults

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04187989
Recruitment Status : Completed
First Posted : December 5, 2019
Results First Posted : February 11, 2022
Last Update Posted : February 11, 2022
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Erin Bonar, University of Michigan

Tracking Information
First Submitted Date  ICMJE December 3, 2019
First Posted Date  ICMJE December 5, 2019
Results First Submitted Date  ICMJE November 19, 2021
Results First Posted Date  ICMJE February 11, 2022
Last Update Posted Date February 11, 2022
Actual Study Start Date  ICMJE February 3, 2020
Actual Primary Completion Date December 18, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2022)
  • Frequency of Cannabis Use as Reported on the Timeline Follow-Back (TLFB) [ Time Frame: 3-months post baseline ]
    30-day TLFB self-report will be used to assess total number of days of cannabis use.
  • Frequency of Cannabis Use as Reported on the Timeline Follow-Back (TLFB) [ Time Frame: 6-months post baseline ]
    30-day TLFB self-report will be used to assess total number of days of cannabis use.
  • Quantity of Cannabis Used as Reported on the Timeline Follow-Back (TLFB) [ Time Frame: 3-months post baseline ]
    30-day Timeline Follow-Back (TLFB) self-report will be used to assess quantity (grams) of cannabis consumed.
  • Quantity of Cannabis Used as Reported on the Timeline Follow-Back (TLFB) [ Time Frame: 6-months post baseline ]
    30-day Timeline Follow-Back (TLFB) self-report will be used to assess quantity (grams) of cannabis consumed.
  • Consequences of Cannabis Use as Measured by the Marijuana Adolescent Consequences Questionnaire Using Dichotomous Response Scale as Previously Described Throughout This Trial Registration. [ Time Frame: 3-months post-baseline ]
    Marijuana Adolescent Consequences Questionnaire will be used to assess past 3 month consequences of cannabis use. Consequences are measured by report of number of times incidents from the list of 26 items (e.g., quality of work suffered, had less energy, etc.) resulted from cannabis use. Responses will be dichotomized (0 = never, 1= greater than never) and summed for a total score reflecting total number of consequences. Response scale: Never 1-2 times 3-5 times 6-10 times More than 10 times Minimum score =0, maximum = 26. Higher score = more consequences.
  • Consequences of Cannabis Use as Measured by the Marijuana Adolescent Consequences Questionnaire [ Time Frame: 6-months post-baseline ]
    Marijuana Adolescent Consequences Questionnaire will be used to assess past 3 month consequences of cannabis use. Consequences are measured by report of number of times incidents from the list of 26 items (e.g., quality of work suffered, had less energy, etc.) resulted from cannabis use. Responses will be dichotomized (0 = never, 1= greater than never) and summed for a total score reflecting total number of consequences. Response scale: Never 1-2 times 3-5 times 6-10 times More than 10 times Minimum score =0, maximum = 26. Higher score = more consequences.
Original Primary Outcome Measures  ICMJE
 (submitted: December 4, 2019)
  • Change in frequency of cannabis use as reported on the Timeline Follow-Back (TLFB) [ Time Frame: 3 and 6 months post-baseline ]
    30-day TLFB self-report will be used to assess total number of days of cannabis use.
  • Change in quantity of cannabis used as reported on the Timeline Follow-Back (TLFB) [ Time Frame: 3 and 6 month post-baseline ]
    30-day Timeline Follow-Back (TLFB) self-report will be used to assess quantity (grams) of cannabis consumed.
  • Change in Consequences of Cannabis Use as measured by the Marijuana Adolescent Consequences Questionnaire [ Time Frame: 3 and 6 months post-baseline ]
    Marijuana Adolescent Consequences Questionnaire will be used to assess past 3 month consequences of cannabis use. Consequences are measured by report of number of times incidents from the list of 26 items (e.g., quality of work suffered, had less energy, etc.) resulted from cannabis use. Responses will be dichotomized (0 = never, 1= greater than never) and summed for a total score reflecting total number of consequences. Response scale: Never 1-2 times 3-5 times 6-10 times More than 10 times
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2022)
  • Perceived Risk of Cannabis Use as Measured by 2 Modified Items From the Monitoring the Future Survey [ Time Frame: 3-months post-baseline ]
    Two items rating current opinion on a scale from "no risk" to "great risk" of their perceived risk harm from occasional cannabis use and regular use. Items are-- How much do you think people risk harming themselves (physically or in other ways), if they:
    1. Use marijuana or marijuana products occasionally
    2. Use marijuana or marijuana products regularly
    Response options are:
    1. No risk
    2. Slight risk
    3. Moderate risk
    4. Great risk
    Answers from both items are added together. The total range of two items summed can be 2-8. Higher totals indicate higher perceived risk.
  • Perceived Risk of Cannabis Use as Measured by Modified Items From the Monitoring the Future Survey [ Time Frame: 6-months post-baseline ]
    Two items rating current opinion on a scale from "no risk" to "great risk" of their perceived risk harm from occasional cannabis use and regular use. Items are-- How much do you think people risk harming themselves (physically or in other ways), if they:
    1. Use marijuana or marijuana products occasionally
    2. Use marijuana or marijuana products regularly
    Response options are:
    1. No risk
    2. Slight risk
    3. Moderate risk
    4. Great risk
    Answers from both items are added together. The total range of two items summed can be 2-8. Higher totals indicate higher perceived risk.
  • Peer Approval/Disapproval of Cannabis Use as Measured by Item Modified From Monitoring the Future Survey [ Time Frame: 3 months post-baseline ]
    One item rating of current perception of whether their close friends would disapprove of their cannabis use (regardless of how much they use), rated as:
    1. Not disapprove
    2. Disapprove
    3. Strongly disapprove
  • Peer Approval/Disapproval of Cannabis Use as Measured by Item Modified From Monitoring the Future Survey [ Time Frame: 6 months post-baseline ]
    One item rating of current perception of whether their close friends would disapprove of their cannabis use (regardless of how much they use), rated as: 1 Not disapprove 2 Disapprove 3 Strongly disapprove
  • Cannabis Impaired Driving as Measured by 5 Items From the Modified Young Adult Driving Questionnaire [ Time Frame: 3 months post-baseline ]
    Five items from the modified Young Adult Driving Questionnaire will be used to assess past 3 month driving under the influence of cannabis. Response values will be summed for a total score. In the PAST 3 MONTHS...how many times did you drive within one hour after using marijuana or marijuana products containing THC?
    • how many times did you drive while a little high on marijuana or marijuana products containing THC?
    • how many times did you drive while very high on marijuana or marijuana products containing THC?
    • how many times did you drive when you knew your use of marijuana/marijuana products containing THC may already have affected your coordination?
    • how many times did you ride in a car or other vehicle driven by someone who had been using marijuana or marijuana products containing THC?
    Response options: 0= Never
    1. Once
    2. Twice
    3. 3 times
    4. 4 times
    5. 5 times
    6. 6-9 times
    7. 10 or more times
  • Cannabis Impaired Driving as Measured by 5 Items From the Modified Young Adult Driving Questionnaire [ Time Frame: 6 months post-baseline ]
    Five items from the modified Young Adult Driving Questionnaire will be used to assess past 3 month driving under the influence of cannabis. Response values will be summed for a total score. In the PAST 3 MONTHS...how many times did you drive within one hour after using marijuana or marijuana products containing THC?
    • how many times did you drive while a little high on marijuana or marijuana products containing THC?
    • how many times did you drive while very high on marijuana or marijuana products containing THC?
    • how many times did you drive when you knew your use of marijuana/marijuana products containing THC may already have affected your coordination?
    • how many times did you ride in a car or other vehicle driven by someone who had been using marijuana or marijuana products containing THC?
    Response options: 0= Never
    1. Once
    2. Twice
    3. 3 times
    4. 4 times
    5. 5 times
    6. 6-9 times
    7. 10 or more times
  • Other Drug Use as Measured by Items Modified From Monitoring the Future Survey [ Time Frame: 3 months post-baseline ]
    Items from the Monitoring the Future Survey will be used to assess past 30 day use of 6 other substances - substances used and number of times of use. Response values will be summed for a total score using mid-point of the range scoring. Substances assessed include: hallucinogens, opioids, stimulants, sedatives, lsd, ecstasy Response scale: 0 0 Occasions
    1. 1-2 Occasions
    2. 3-5 Occasions
    3. 6-9 Occasions
    4. 10-19 Occasions
    5. 20-39 Occasions
    6. 40 or More Occasions
  • Other Drug Use as Measured by Items Modified From Monitoring the Future Survey [ Time Frame: 6 months post-baseline ]
    Items from the Monitoring the Future Survey will be used to assess past 30 day use of 6 other substances - substances used and number of times of use. Response values will be summed for a total score using mid-point of the range scoring. Substances assessed include: hallucinogens, opioids, stimulants, sedatives, lsd, ecstasy Response scale: 0 0 Occasions
    1. 1-2 Occasions
    2. 3-5 Occasions
    3. 6-9 Occasions
    4. 10-19 Occasions
    5. 20-39 Occasions
    6. 40 or More Occasions
  • Frequency of Alcohol Consumption as Reported on the Timeline Follow-Back (TLFB) [ Time Frame: 3 months post-baseline ]
    30-day TLFB self-report will be used to assess total number of days of alcohol consumption.
  • Frequency of Alcohol Consumption as Reported on the Timeline Follow-Back (TLFB) [ Time Frame: 6 months post-baseline ]
    30-day TLFB self-report will be used to assess total number of days of alcohol consumption.
  • Quantity of Alcohol Consumption as Reported on the Timeline Follow-Back (TLFB) [ Time Frame: 3 months post-baseline ]
    30-day TLFB self-report will be used to assess the quantity of alcohol consumed.
  • Quantity of Alcohol Consumption as Reported on the Timeline Follow-Back (TLFB) [ Time Frame: 6 months post-baseline ]
    30-day TLFB self-report will be used to assess the quantity of alcohol consumed.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2019)
  • Change in perceived risk of cannabis use as measured by modified items from the Monitoring the Future survey [ Time Frame: 3 and 6 months post-baseline ]
    Two items rating current opinion on a scale from "no risk" to "great risk" of their perceived risk harm from occasional cannabis use and regular use.
  • Change in peer approval/disapproval of cannabis use as measured by item modified from Monitoring the Future Survey [ Time Frame: 3 and 6 months post-baseline ]
    One item rating of current perception of whether their close friends would disapprove of their cannabis use (regardless of how much they use), rated as: 1 Not disapprove 2 Disapprove 3 Strongly disapprove
  • Changes in cannabis impaired driving as measured by 5 items from the modified Young Adult Driving Questionnaire [ Time Frame: 3 and 6 months post-baseline ]
    Five items from the modified Young Adult Driving Questionnaire will be used to assess past 3 month driving under the influence of cannabis. Questions include report of number of times of driving under different levels of cannabis use. Response values will be summed for a total score. Response scale: 0 Never
    1. 1-2 times
    2. 3-5 times
    3. 6-10 times
    4. 10+ times
  • Change in other drug use as measured by items modified from Monitoring the Future survey [ Time Frame: 3 and 6 months post-baseline ]
    Items from the Monitoring the Future Survey will be used to assess past 30 day use of 9 other substances - substances used and number of times of use. Response values will be summed for a total score. Response scale: 0 0 Occasions
    1. 1-2 Occasions
    2. 3-5 Occasions
    3. 6-9 Occasions
    4. 10-19 Occasions
    5. 20-39 Occasions
    6. 40 or More Occasions
  • Change in frequency of alcohol consumption as reported on the Timeline Follow-Back (TLFB) [ Time Frame: 3 and 6 months post-baseline ]
    30-day TLFB self-report will be used to assess total number of days of alcohol consumption.
  • Change in quantity of alcohol consumption as reported on the Timeline Follow-Back (TLFB) [ Time Frame: 3 and 6 months post-baseline ]
    30-day TLFB self-report will be used to assess the quantity of alcohol consumed.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Social Media Intervention for Cannabis Use in Emerging Adults
Official Title  ICMJE Social Media Intervention for Cannabis Use in Emerging Adults
Brief Summary The purpose of the study is to develop and test social media interventions to help young people increase well-being and reduce risky behaviors. The study will help researchers learn about ways to deliver wellness information in a way that is appealing and helpful to young people who use Facebook.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Cannabis Use
Intervention  ICMJE Behavioral: Social Media Intervention
Information will be posted by e-coaches. You can interact with the e-coaches as well as other study members in your group.
Study Arms  ICMJE
  • Experimental: Social Media Intervention
    Facebook page that will deliver health information focused on increasing well-being and reducing risky behaviors.
    Intervention: Behavioral: Social Media Intervention
  • No Intervention: Control
    An Attention-Control E-News (control) condition
Publications * Bonar EE, Goldstick JE, Chapman L, Bauermeister JA, Young SD, McAfee J, Walton MA. A social media intervention for cannabis use among emerging adults: Randomized controlled trial. Drug Alcohol Depend. 2022 Mar 1;232:109345. doi: 10.1016/j.drugalcdep.2022.109345. Epub 2022 Feb 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 19, 2022)		 149
Original Estimated Enrollment  ICMJE
 (submitted: December 4, 2019)		 180
Actual Study Completion Date  ICMJE December 18, 2020
Actual Primary Completion Date December 18, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • self-report using cannabis at least 3 time per week or more often in the past month
  • active Facebook profile
  • view and click on a social media ad

Exclusion Criteria:

  • fail identity verification based on 1) Internet Protocol (IP) addresses, 2) survey time completion, 3) repeat attempts, 4) survey responses, and 5) photo identification via a timestamped selfie sent to the research staff.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 25 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04187989
Other Study ID Numbers  ICMJE HUM00152202
R34DA045712 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Erin Bonar, University of Michigan
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Michigan
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Erin Bonar University of Michigan
PRS Account University of Michigan
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP