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| ID | Type | Description | Link |
|---|---|---|---|
| R18HS030202 | U.S. AHRQ Grant/Contract | View source |
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The goal of this clinical trial is to learn if a new smartphone-based intervention can help with factors related to opioid misuse in parents and adolescent/early adult children. The main question it aims to answer is:
• Can this intervention improve knowledge of, and attitudes towards, opioid misuse over traditional opioid-related counseling alone?
Participants will, in addition to receiving opioid counseling:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | This group will receive the intervention of interest, MedSMA℞T Mobile, in addition to standard opioid-related counseling. MedSMA℞T Mobile is a serious game (intended to educate while entertaining) focused on opioid safety. |
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| Control | No Intervention | This group will receive the standard opioid-related counseling that all patients receive when newly prescribed opioids in the emergency department. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MedSMA℞T Mobile | Behavioral | MedSMA℞T Mobile is an innovative mobile digital health intervention that integrates technology-based learning to facilitate family communication and creation of a personalized Family Medication Safety Plan. The Family Medication Safety Plan (FMSP) is a tool for families to record important information about their medications and create a plan for safe use, storage, and disposal. Participants will play MedSMA℞T Mobile for up to 30 minutes at the first study visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Adolescent Opioid Safety and Learning (AOSL) scale score over 9 month study | The fourth factor of the Adolescent Opioid Safety and Learning (AOSL) scale, Opioid Harm, measures understanding of negative social and professional effects of opioid misuse. Scores range from 3-15, where 3 indicates the lowest level of overall opioid harm awareness and 15 is the highest level. | Baseline, 3, 6, and 9 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Safe Opioid Storage Behaviour over 9 months | This outcome contains 4 items from the Wisconsin Strategic Prevention Framework Partnerships for Success Community Survey - V02, comprised of yes/no questions. The minimum score for this scale is 0 (indicating least safe opioid storage behaviour) and the maximum is 4 (indicating most safe opioid storage behaviour). | Baseline, 3, 6, and 9 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joseph Strong | Contact | 859-562-2766 | jmstrong@uky.edu |
| Name | Affiliation | Role |
|---|---|---|
| Olufunmilola Abraham, PhD | University of Kentucky College of Pharmacy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swedish American Hospital | Rockford | Illinois | 61104 | United States |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Change in Opioid Disposal Behaviour over 9 months | This outcome contains 6 items from the Wisconsin Strategic Prevention Framework Partnerships for Success Community Survey - V02, and includes yes/no questions. The minimum score for this scale is 0 (indicating least safe opioid disposal behaviour) and the maximum is 6 (indicating most safe opioid disposal behaviour). | Baseline, 3, 6, and 9 months. |
| Change in Medication Understanding and Use Self-Efficacy (MUSE) scale scores over 9 months | This section covers the second factor, Learning About Medication, of the Medication Understanding and Use Self-Efficacy (MUSE) scale. This factor is comprised of 4 items, each scored 1-4. The minimum score is 4, and the maximum is 16. A score of 4 indicates lower understanding and self-efficacy in opioid use, whereas a score of 16 indicates highest level of understanding and self-efficacy in opioid use. | Baseline, 3, 6, and 9 months. |
| Change in Family Communication Behaviour Patterns over 9 months | This includes both the parent and child versions of the 26-item, 2-factor scales. The first factor, Conversation orientation, contains 15 items. The second factor, Conformity orientation, contains 11 items. Items are scored from 1-5, where 1 is "Disagree Strongly" and 5 is "Agree Strongly". Scale scores are averages for the two scales, with each item contributing equally. The minimum and maximum average scores, therefore, cannot exceed 1 and 5, respectively. | Baseline, 3, 6, and 9 months. |
| East Madison Hospital | Madison | Wisconsin | 53718 | United States |
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| University Hospital | Madison | Wisconsin | 53792 | United States |
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