MedSMA℞T Mobile ED

March 13, 2026 updated by: Olufunmilola Abraham

Implementing MedSMA℞T Families in the Emergency Department Setting: A Game-based Approach for Improving Opioid Safety Among Adolescents and Parents

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

244

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Rockford, Illinois, United States, 61104
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University Hospital
        • Contact:
        • Principal Investigator:
          • Allie Hurst, MD
      • Madison, Wisconsin, United States, 53718
        • East Madison Hospital
        • Contact:
        • Contact:
          • Kayla Zubke
          • Phone Number: 608-421-7367

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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.
Behavioral: MedSMA℞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.
No Intervention: Control
This group will receive the standard opioid-related counseling that all patients receive when newly prescribed opioids in the emergency department.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Adolescent Opioid Safety and Learning (AOSL) scale score over 9 month study
Time Frame: 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.
Baseline, 3, 6, and 9 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Safe Opioid Storage Behaviour over 9 months
Time Frame: 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).
Baseline, 3, 6, and 9 months.
Change in Opioid Disposal Behaviour over 9 months
Time Frame: 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).
Baseline, 3, 6, and 9 months.
Change in Medication Understanding and Use Self-Efficacy (MUSE) scale scores over 9 months
Time Frame: 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.
Baseline, 3, 6, and 9 months.
Change in Family Communication Behaviour Patterns over 9 months
Time Frame: 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.
Baseline, 3, 6, and 9 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Olufunmilola Abraham

Investigators

  • Principal Investigator: Olufunmilola Abraham, PhD, University of Kentucky College of Pharmacy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

February 21, 2025

First Submitted That Met QC Criteria

February 21, 2025

First Posted (Actual)

February 27, 2025

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 98853
  • R18HS030202 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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