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| ID | Type | Description | Link |
|---|---|---|---|
| 5P50DA054039-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study is being completed to pilot prevention methods to promote wellness and reduce risky behaviors, including the use of substances such as cannabis. This study will help researchers learn about ways of delivering this information that is both appealing and helpful to young adults who use mobile apps.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JITAI | Experimental | Experimental: Within-participant micro-randomization Twice daily in the study, a participant is assigned to receive a message or no message. The micro-randomization will be performed by a reinforcement learning algorithm based on the participant's engagement with the intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Just-In-Time-Adaptive-Intervention (JITAI) | Other | Behavioral: MiWaves behavioral messages Participants will be using the MiWaves mobile app for 30 days. When a participant is assigned to receive a message, a message will be randomly selected from a pool of intervention message sets. Messages are based in motivational interviewing and include affect management and behavioral economic strategies. |
| Measure | Description | Time Frame |
|---|---|---|
| App Feasibility | % of participants who consented to the study who download the MiWaves app. | 1 month |
| App Acceptability | Participants will complete acceptability ratings for the MiWaves app within their post-test assessment (percent with positive rating). | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39159806 | Derived | Coughlin LN, Campbell M, Wheeler T, Rodriguez C, Florimbio AR, Ghosh S, Guo Y, Hung PY, Newman MW, Pan H, Zhang KW, Zimmermann L, Bonar EE, Walton M, Murphy S, Nahum-Shani I. A mobile health intervention for emerging adults with regular cannabis use: A micro-randomized pilot trial design protocol. Contemp Clin Trials. 2024 Oct;145:107667. doi: 10.1016/j.cct.2024.107667. Epub 2024 Aug 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | JITAI | Experimental: Within-participant micro-randomization Twice daily in the study, a participant is assigned to receive a message or no message. The micro-randomization will be performed by a reinforcement learning algorithm based on the participant's engagement with the intervention. Just-In-Time-Adaptive-Intervention (JITAI): Behavioral: MiWaves behavioral messages Participants will be using the MiWaves mobile app for 30 days. When a participant is assigned to receive a message, a message will be randomly selected from a pool of intervention message sets. Messages are based in motivational interviewing and include affect management and behavioral economic strategies. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | JITAI | Experimental: Within-participant micro-randomization Twice daily in the study, a participant is assigned to receive a message or no message. The micro-randomization will be performed by a reinforcement learning algorithm based on the participant's engagement with the intervention. Just-In-Time-Adaptive-Intervention (JITAI): Behavioral: MiWaves behavioral messages Participants will be using the MiWaves mobile app for 30 days. When a participant is assigned to receive a message, a message will be randomly selected from a pool of intervention message sets. Messages are based in motivational interviewing and include affect management and behavioral economic strategies. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | App Feasibility | % of participants who consented to the study who download the MiWaves app. | App feasibility outcome is operationalized as % of participants who consented to the study who download the MiWaves app. Not all that consented to the study were included in study flow since not all that consented downloaded the app. Therefore, the number analyzed for app feasibility is greater than the number in the participant flow. | Posted | Count of Participants | Participants | 1 month |
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Up to 2.5 months. After enrollment, participants were followed for AEs until either: a) The participant completes the follow-up survey (2-months post enrollment) b) The window for completing the follow-up survey passed (2 weeks after sending follow-up survey) Therefore, the maximum amount of time a participant would be followed for AEs is 2.5 months post-enrollment.
There are no adverse events to report.
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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 | JITAI | Experimental: Within-participant micro-randomization Twice daily in the study, a participant is assigned to receive a message or no message. The micro-randomization will be performed by a reinforcement learning algorithm based on the participant's engagement with the intervention. Just-In-Time-Adaptive-Intervention (JITAI): Behavioral: MiWaves behavioral messages Participants will be using the MiWaves mobile app for 30 days. When a participant is assigned to receive a message, a message will be randomly selected from a pool of intervention message sets. Messages are based in motivational interviewing and include affect management and behavioral economic strategies. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Inbal Billie Nahum-Shani | University of Michigan | 7346609626 | inbal@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 | Mar 26, 2024 | Apr 2, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 28, 2024 | Apr 2, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| D019966 | Substance-Related Disorders |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | App Acceptability | Participants will complete acceptability ratings for the MiWaves app within their post-test assessment (percent with positive rating). | Posted | Count of Participants | Participants | 1 month |
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