Health TrialsbyHealthPanel

MedSMA℞T Mobile ED

ConditionsOpiate-Related DisordersOpiate Use DisorderOpioid
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorOlufunmilola Abraham

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

244 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

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.

Time frame
Baseline, 3, 6, and 9 months.

Secondary outcomes

1

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).

Time frame
Baseline, 3, 6, and 9 months.
2

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).

Time frame
Baseline, 3, 6, and 9 months.
3

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.

Time frame
Baseline, 3, 6, and 9 months.
4

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.

Time frame
Baseline, 3, 6, and 9 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Olufunmilola Abraham

Lead sponsor

University of Kentucky

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: