Visual Distraction as a Means of Enhancing Child Resistance (VDCR)

May 1, 2024 updated by: Laura Bix, Michigan State University

Unintentional poisonings of children continues to be a major issue in the US. According to a study conducted by Cincinnati Children's Hospital Medical Centers, during the period from 2001-2008, emergency room visits for children less than 5 rose 28% as the result of pharmaceutical products. The authors note, "the problem of pediatric medication poisoning is getting worse, not better."

Child resistant closures have been required on most medications sold in the US since the early 1970s. However, most designs attempt to thwart children through purely physical means (e.g. simultaneous dissimilar motion or opening using sequential tasks). Few, if any designs, have utilized perception and cognition as a way to enhance child resistance.

The investigators propose utilizing visual illusions in spaces distinct from the opening mechanism of prescription packages as a means of enhancing child resistance. In this project, visual illusion images are applied to both vials and wallet blisters in order to attract children's interest and prolong the time before opening.

During Stage I, the investigators will determine if the visual distractor attracts attention when samples are displayed in a storage rack. During Stage II, the investigators will test the effect of visual distractors on child resistance as measured by successful openings and time to open.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Stage I

Objective: to determine if the visual distractor attracts attention when samples are displayed in a storage rack.

Eligibility Criteria

To participate in this study children must:

  • Be 2 years to 4 ½ years old
  • Have parent's permission to be videotaped
  • Have parent's signed permission (in the form of the official (IRB approved, signed consent)
  • Have no known history of lactose allergy or lactose sensitivity (packages contain a lactose placebo)
  • Verbally agree to participate after a brief explanation of what we want them to do

Outcome Measures Categorical variable (package choice) Continuous variable (time to choice)

Stage II Objective: to test the effect of visual distractors on child resistance as measured by successful openings and time to open.

Eligibility Criteria

To participate in this stage of the study children must:

  • Have no known history of lactose allergy or lactose sensitivity (packages contain a lactose placebo)
  • Be 2 years to 4 ½ years old
  • Have their parent's permission to be videotaped
  • Have their parent's permission (in the form of the official, IRB approved signed consent)
  • Verbally agree to participate after a brief explanation of what we want them to do

Outcome Measures Binary (package opened yes/no) Continuous variable (time to open for those successful)

Study Type

Interventional

Enrollment (Actual)

229

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 Locations

  • United States
    • Michigan
      • East Lansing, Michigan, United States, 48824
        • Packaging Building
      • Howell, Michigan, United States, 48843
        • LESA Early Childhood Programs
    • Ohio
      • Toledo, Ohio, United States, 43606
        • Great Lakes Marketing

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

2 years to 4 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 2-4.5 years of age
  • Parental permission to video tape

Exclusion Criteria:

  • Lactose allergy or lactose sensitivity

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prescription packages (vials and blisters)

Stage I Prescription vials and wallets (packaging) with three levels of distractor placement (hidden, absent and obvious) will be tested for an effect of placement on selection behavior and time to package selection.

Stage II Prescription vials and wallets (packaging) with and without distractors will be tested for an effect on time to open and number of successful openings.
Other: Visual distractor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Package selection
Time Frame: Day of experiment- Stage I
Selection of one of three treatments in stage one testing (categorical variable)
Day of experiment- Stage I
Time to opening
Time Frame: Day of experiment (Stage II)
Time it takes a participant to successfully open a given treatment (continuous variable)
Day of experiment (Stage II)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to selection (continuous variable)
Time Frame: Day of the experiment- Stage I
Time it takes participants to select package (continuous variable)
Day of the experiment- Stage I
Success/Failure to open
Time Frame: Day of the experiment (Stage II)
Success or failure in opening by package treatment (binary response variable)
Day of the experiment (Stage II)

Collaborators and Investigators

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

Sponsor

Michigan State University

Investigators

  • Principal Investigator: Laura Bix, PhD, School of Packaging, Michigan State University
  • Principal Investigator: Mark Becker, PhD, Cognition and Cognitive Neuroscience Group
  • Principal Investigator: Judith Danovitch, PhD, Knowledge in Development Lab, Psychology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

August 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

May 1, 2013

First Submitted That Met QC Criteria

May 20, 2013

First Posted (Estimated)

May 22, 2013

Study Record Updates

Last Update Posted (Estimated)

May 3, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-246

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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