Clinical Trial: Visual Distraction as a Means of Enhancing Child Resistance

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Visual Distraction as a Means of Enhancing Child Resistance

Brief Summary:

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.


Detailed Summary:

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 b
    Sponsor: Michigan State University

    Current Primary Outcome:

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


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

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


    Original Secondary Outcome: Same as current

    Information By: Michigan State University

    Dates:
    Date Received: May 1, 2013
    Date Started: August 2013
    Date Completion:
    Last Updated: April 6, 2015
    Last Verified: April 2015