NCT06848504

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

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Sep 2026

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
1.5 years until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

February 21, 2025

Last Update Submit

March 13, 2026

Conditions

Opiate-Related DisordersOpiate Use DisorderOpioid

Keywords

Opioid EducationOpioid Use DisorderOpiate-Related DisordersOpiateOpioidSerious GameSmartphoneSmartphone GameMedication safetyAdolescent Health

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (4)

  • Change in Safe Opioid Storage Behaviour over 9 months

    Baseline, 3, 6, and 9 months.

  • Change in Opioid Disposal Behaviour over 9 months

    Baseline, 3, 6, and 9 months.

  • Change in Medication Understanding and Use Self-Efficacy (MUSE) scale scores over 9 months

    Baseline, 3, 6, and 9 months.

  • Change in Family Communication Behaviour Patterns over 9 months

    Baseline, 3, 6, and 9 months.

Study Arms (2)

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.

Behavioral: MedSMA℞T Mobile

Control

NO INTERVENTION

This group will receive the standard opioid-related counseling that all patients receive when newly prescribed opioids in the emergency department.

Interventions

MedSMA℞T MobileBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Swedish American Hospital

Rockford, Illinois, 61104, United States

Location

East Madison Hospital

Madison, Wisconsin, 53718, United States

Location

University Hospital

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Olufunmilola Abraham, PhD

    University of Kentucky College of Pharmacy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Strong

CONTACT

859-562-2766jmstrong@uky.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 21, 2025

First Posted

February 27, 2025

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(3)