Opiate-Related Disorders, Opiate Use Disorder, Opioid
Conditions
Keywords
Opioid Education, Opioid Use Disorder, Opiate-Related Disorders, Opiate, Opioid, Serious Game, Smartphone, Smartphone Game, Medication safety, Adolescent Health
Brief summary
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: * Join an online meeting with research staff to test the smartphone-based intervention * Report demographic information * Complete surveys about opioids * Complete a family medication safety plan * Complete surveys after 3, 6, and 9 months
Interventions
BEHAVIORALMedSMA℞T Mobile
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.
Sponsors
Olufunmilola Abraham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults who receive an opioid prescription from a study Emergency Department, AND * who report having an adolescent, aged 12-18, living at home, AND * who speak and understand English * Each participant must have the ability to provide informed consent
Exclusion criteria
* Adults who do not receive an opioid prescription from a study Emergency Department AND/OR * who do not have an adolescent, aged 12-18, living at home, AND/OR * who do not speak or understand English * Adults and/or adolescents who do not have the ability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Adolescent Opioid Safety and Learning (AOSL) scale score over 9 month study | Baseline, 3, 6, and 9 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Safe Opioid Storage Behaviour over 9 months | Baseline, 3, 6, and 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). |
| Change in Opioid Disposal Behaviour over 9 months | Baseline, 3, 6, and 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). |
| Change in Medication Understanding and Use Self-Efficacy (MUSE) scale scores over 9 months | Baseline, 3, 6, and 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. |
| Change in Family Communication Behaviour Patterns over 9 months | Baseline, 3, 6, and 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. |
Countries
United States
Contacts
CONTACTJoseph Strong
PRINCIPAL_INVESTIGATOROlufunmilola Abraham, PhD
University of Kentucky College of Pharmacy
Outcome results
None listed