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| ID | Type | Description | Link |
|---|---|---|---|
| R34DA045712 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Social Media Intervention | Experimental | Facebook page that will deliver health information focused on increasing well-being and reducing risky behaviors. |
|
| Control | No Intervention | An Attention-Control E-News (control) condition |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Social Media Intervention | Behavioral | Information will be posted by e-coaches. You can interact with the e-coaches as well as other study members in your group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Cannabis Use as Reported on the Timeline Follow-Back (TLFB) | 30-day TLFB self-report will be used to assess total number of days of cannabis use. | 3-months post baseline |
| Frequency of Cannabis Use as Reported on the Timeline Follow-Back (TLFB) | 30-day TLFB self-report will be used to assess total number of days of cannabis use. | 6-months post baseline |
| Quantity of Cannabis Used as Reported on the Timeline Follow-Back (TLFB) | 30-day Timeline Follow-Back (TLFB) self-report will be used to assess quantity (grams) of cannabis consumed. | 3-months post baseline |
| Quantity of Cannabis Used as Reported on the Timeline Follow-Back (TLFB) | 30-day Timeline Follow-Back (TLFB) self-report will be used to assess quantity (grams) of cannabis consumed. | 6-months post baseline |
| Consequences of Cannabis Use as Measured by the Marijuana Adolescent Consequences Questionnaire Using Dichotomous Response Scale as Previously Described Throughout This Trial Registration. | 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. | 3-months post-baseline |
| Consequences of Cannabis Use as Measured by the Marijuana Adolescent Consequences Questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Risk of Cannabis Use as Measured by 2 Modified Items From the Monitoring the Future Survey | 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:
Response options are:
Answers from both items are added together. The total range of two items summed can be 2-8. Higher totals indicate higher perceived risk. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erin Bonar | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35144238 | Derived | 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. |
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There were 2 waves of recruitment: Wave 1 (February 2020) occurred for participants residing in states without legal recreational cannabis; Wave 2 (May 2020) occurred for those living in states with legal recreational cannabis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Social Media Intervention | Facebook page that will deliver health information focused on increasing well-being and reducing risky behaviors. 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. |
| FG001 | Control | An Attention-Control E-News (control) condition |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study - 3-Month Follow-Up |
|
| ||||||||||||||||||
| Overall Study - 6-Month Follow-Up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Social Media Intervention | Facebook page that will deliver health information focused on increasing well-being and reducing risky behaviors. 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequency of Cannabis Use as Reported on the Timeline Follow-Back (TLFB) | 30-day TLFB self-report will be used to assess total number of days of cannabis use. | Posted | Mean | Standard Deviation | days | 3-months post baseline |
|
From baseline to 6-month follow-up. Note that adverse events were monitored but none occurred; this is a no more than minimal risk study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Social Media Intervention | Facebook page that will deliver health information focused on increasing well-being and reducing risky behaviors. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Erin Bonar | University of Michigan | 7347647936 | erinbona@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 18, 2021 | Dec 17, 2021 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 22, 2019 | Feb 16, 2021 | ICF_000.pdf |
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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. |
| 6-months post-baseline |
| 3-months post-baseline |
| Perceived Risk of Cannabis Use as Measured by Modified Items From the Monitoring the Future Survey | 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:
Response options are:
Answers from both items are added together. The total range of two items summed can be 2-8. Higher totals indicate higher perceived risk. | 6-months post-baseline |
| Peer Approval/Disapproval of Cannabis Use as Measured by Item Modified From Monitoring the Future Survey | 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:
| 3 months post-baseline |
| Peer Approval/Disapproval of Cannabis Use as Measured by Item Modified From Monitoring the Future Survey | 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 | 6 months post-baseline |
| Cannabis Impaired Driving as Measured by 5 Items From the Modified Young Adult Driving Questionnaire | 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?
Response options: 0= Never
| 3 months post-baseline |
| Cannabis Impaired Driving as Measured by 5 Items From the Modified Young Adult Driving Questionnaire | 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?
Response options: 0= Never
| 6 months post-baseline |
| Other Drug Use as Measured by Items Modified From Monitoring the Future Survey | 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
| 3 months post-baseline |
| Other Drug Use as Measured by Items Modified From Monitoring the Future Survey | 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
| 6 months post-baseline |
| Frequency of Alcohol Consumption as Reported on the Timeline Follow-Back (TLFB) | 30-day TLFB self-report will be used to assess total number of days of alcohol consumption. | 3 months post-baseline |
| Frequency of Alcohol Consumption as Reported on the Timeline Follow-Back (TLFB) | 30-day TLFB self-report will be used to assess total number of days of alcohol consumption. | 6 months post-baseline |
| Quantity of Alcohol Consumption as Reported on the Timeline Follow-Back (TLFB) | 30-day TLFB self-report will be used to assess the quantity of alcohol consumed. | 3 months post-baseline |
| Quantity of Alcohol Consumption as Reported on the Timeline Follow-Back (TLFB) | 30-day TLFB self-report will be used to assess the quantity of alcohol consumed. | 6 months post-baseline |
| NOT COMPLETED |
|
|
| Control |
An Attention-Control E-News (control) condition |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Total days of cannabis use in past 30 (from Timeline Follow Back: TLFB) | Mean | Standard Deviation | days |
|
| Total estimated grams cannabis use from Timeline Follow Back (past 30 days) | 2 participants in the control group had missing baseline data on quantity | Mean | Standard Deviation | grams |
|
| Total consequences from Marijuana Adolescent Consequences Questionnaire | 2 participants in the control group are missing data on the consequences measure | Mean | Standard Deviation | count of consequences |
|
| Perceived risk | Two control participants were missing baseline data on this measure | Mean | Standard Deviation | units on a scale |
|
| Peer approval | 3 control participants are missing data on this measure at baseline | Mean | Standard Deviation | units on a scale |
|
| Cannabis-impaired driving | 2 control participants had missing data on this scale | Mean | Standard Deviation | units on a scale |
|
| Past 30-day other substance use index | 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 1-2 Occasions 3-5 Occasions 6-9 Occasions 10-19 Occasions 20-39 Occasions 40 or More Occasions Higher scores = greater substance use | Mean | Standard Deviation | mid-point of range total score across 6 |
|
| Alcohol use days in past 30 (from Timeline Follow Back: TLFB) | This measure restricted to only those participants who drank alcohol at baseline | Mean | Standard Deviation | days |
|
| Alcohol quantity (total drinks) in past 30 days | This measure restricted to those who drank alcohol at baseline. | Mean | Standard Deviation | estimated standard drinks |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Frequency of Cannabis Use as Reported on the Timeline Follow-Back (TLFB) | 30-day TLFB self-report will be used to assess total number of days of cannabis use. | Posted | Mean | Standard Deviation | days | 6-months post baseline |
|
|
|
|
| Primary | Quantity of Cannabis Used as Reported on the Timeline Follow-Back (TLFB) | 30-day Timeline Follow-Back (TLFB) self-report will be used to assess quantity (grams) of cannabis consumed. | Posted | Mean | Standard Deviation | quantity (grams) | 3-months post baseline |
|
|
|
| Primary | Quantity of Cannabis Used as Reported on the Timeline Follow-Back (TLFB) | 30-day Timeline Follow-Back (TLFB) self-report will be used to assess quantity (grams) of cannabis consumed. | Posted | Mean | Standard Deviation | quantity (grams) | 6-months post baseline |
|
|
|
|
| Primary | Consequences of Cannabis Use as Measured by the Marijuana Adolescent Consequences Questionnaire Using Dichotomous Response Scale as Previously Described Throughout This Trial Registration. | 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. | Posted | Mean | Standard Deviation | total number of consequences (count) | 3-months post-baseline |
|
|
|
|
| Primary | Consequences of Cannabis Use as Measured by the Marijuana Adolescent Consequences Questionnaire | 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. | Posted | Mean | Standard Deviation | total consequences (count) | 6-months post-baseline |
|
|
|
|
| Secondary | Perceived Risk of Cannabis Use as Measured by 2 Modified Items From the Monitoring the Future Survey | 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:
Response options are:
Answers from both items are added together. The total range of two items summed can be 2-8. Higher totals indicate higher perceived risk. | Posted | Mean | Standard Deviation | total of two items | 3-months post-baseline |
|
|
|
|
| Secondary | Perceived Risk of Cannabis Use as Measured by Modified Items From the Monitoring the Future Survey | 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:
Response options are:
Answers from both items are added together. The total range of two items summed can be 2-8. Higher totals indicate higher perceived risk. | Posted | Mean | Standard Deviation | total of two items | 6-months post-baseline |
|
|
|
|
| Secondary | Peer Approval/Disapproval of Cannabis Use as Measured by Item Modified From Monitoring the Future Survey | 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:
| Number of participants analyzed is due to missing data | Posted | Mean | Standard Deviation | score on the single item | 3 months post-baseline |
|
|
|
|
| Secondary | Peer Approval/Disapproval of Cannabis Use as Measured by Item Modified From Monitoring the Future Survey | 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 | Number of participants analyzed is due to missing data | Posted | Mean | Standard Deviation | score on the single item | 6 months post-baseline |
|
|
|
|
| Secondary | Cannabis Impaired Driving as Measured by 5 Items From the Modified Young Adult Driving Questionnaire | 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?
Response options: 0= Never
| Posted | Mean | Standard Deviation | total of 5 items (range = 0 to 35) | 3 months post-baseline |
|
|
|
|
| Secondary | Cannabis Impaired Driving as Measured by 5 Items From the Modified Young Adult Driving Questionnaire | 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?
Response options: 0= Never
| Posted | Mean | Standard Deviation | total of 5 items (range 0 to 35) | 6 months post-baseline |
|
|
|
|
| Secondary | Other Drug Use as Measured by Items Modified From Monitoring the Future Survey | 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
| Posted | Mean | Standard Deviation | total of 6 items using mid-point scoring | 3 months post-baseline |
|
|
|
|
| Secondary | Other Drug Use as Measured by Items Modified From Monitoring the Future Survey | 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
| Posted | Mean | Standard Deviation | total of 6 items using midpoint of range | 6 months post-baseline |
|
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|
|
| Secondary | Frequency of Alcohol Consumption as Reported on the Timeline Follow-Back (TLFB) | 30-day TLFB self-report will be used to assess total number of days of alcohol consumption. | Number of participants analyzed is due to focus on alcohol drinkers only | Posted | Mean | Standard Deviation | days | 3 months post-baseline |
|
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|
|
| Secondary | Frequency of Alcohol Consumption as Reported on the Timeline Follow-Back (TLFB) | 30-day TLFB self-report will be used to assess total number of days of alcohol consumption. | Number of participants analyzed is due to focus on alcohol drinkers only | Posted | Mean | Standard Deviation | days | 6 months post-baseline |
|
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|
|
| Secondary | Quantity of Alcohol Consumption as Reported on the Timeline Follow-Back (TLFB) | 30-day TLFB self-report will be used to assess the quantity of alcohol consumed. | Number of participants analyzed is due to focus on alcohol drinkers only | Posted | Mean | Standard Deviation | estimated standard drinks | 3 months post-baseline |
|
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|
|
| Secondary | Quantity of Alcohol Consumption as Reported on the Timeline Follow-Back (TLFB) | 30-day TLFB self-report will be used to assess the quantity of alcohol consumed. | Number of participants analyzed is due to focus on alcohol drinkers only | Posted | Mean | Standard Deviation | estimated standard drinks | 6 months post-baseline |
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|
| 0 |
| 76 |
| 0 |
| 76 |
| 0 |
| 76 |
| EG001 | Control | An Attention-Control E-News (control) condition | 0 | 73 | 0 | 73 | 0 | 73 |
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| Unknown or Not Reported |
|
| Other |
Two-sided test of the null hypothesis of no difference between groups |
The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects). |
| Other |
Two-sided test of the null hypothesis of no difference between groups |
| Other |
Two-sided test of the null hypothesis of no difference between groups |
| Other |
Two-sided test of the null hypothesis of no difference between groups |
| Other |
Two-sided test of the null hypothesis of no difference between groups |
| Other |
Two-sided test of the null hypothesis of no difference between groups |
| Other |
Two-sided test of the null hypothesis of no difference between groups |
| Other |
Two-sided test of the null hypothesis of no difference between groups |
| Other |
Two-sided test of the null hypothesis of no difference between groups |
| Other |
Two-sided test of the null hypothesis of no difference between groups |
| Other |
Two-sided test of the null hypothesis of no difference between groups |
The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects). |
| Other |
Two-sided test of the null hypothesis of no difference between groups |
| Other |
Two-sided test of the null hypothesis of no difference between groups |
| Other |
Two-sided test of the null hypothesis of no difference between groups |
| Other |
Two-sided test of the null hypothesis of no difference between groups |