Visual Distraction as a Means of Enhancing Child Resistance
NCT ID: NCT01859780
Last Updated: 2024-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
229 participants
INTERVENTIONAL
2013-08-31
2015-04-30
Brief Summary
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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.
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Detailed Description
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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)
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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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.
Visual distractor
Interventions
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Visual distractor
Eligibility Criteria
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Inclusion Criteria
* Parental permission to video tape
Exclusion Criteria
2 Years
54 Months
ALL
Yes
Sponsors
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Michigan State University
OTHER
Responsible Party
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Laura Bix
Associate Professor
Principal Investigators
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Laura Bix, PhD
Role: PRINCIPAL_INVESTIGATOR
School of Packaging, Michigan State University
Mark Becker, PhD
Role: PRINCIPAL_INVESTIGATOR
Cognition and Cognitive Neuroscience Group
Judith Danovitch, PhD
Role: PRINCIPAL_INVESTIGATOR
Knowledge in Development Lab, Psychology
Locations
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Packaging Building
East Lansing, Michigan, United States
LESA Early Childhood Programs
Howell, Michigan, United States
Great Lakes Marketing
Toledo, Ohio, United States
Countries
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Related Links
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Up and Away Campaign (brochures from this campaign will be sent home with children after testing)
Other Identifiers
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13-246
Identifier Type: -
Identifier Source: org_study_id
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