Visual Distraction as a Means of Enhancing Child Resistance

Study Overview
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Brief Summary
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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 Description
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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)

Official Title
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Visual Distraction as a Means of Enhancing Child Resistance

Conditions
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Unintentional Ingestion of Drugs Contained Within Prescription Vials and Blisters.

Intervention / Treatment
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* Other: Visual distractor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 2-4.5 years of age Parental permission to video tape Exclusion Criteria: Lactose allergy or lactose sensitivity

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 54 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prescription packages (vials and blisters)<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Package selection | Selection of one of three treatments in stage one testing (categorical variable) | Day of experiment- Stage I | 
| Time to opening | 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 it takes participants to select package (continuous variable) | Day of the experiment- Stage I | 
| Success/Failure to open | Success or failure in opening by package treatment (binary response variable) | Day of the experiment (Stage II) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Poison control, Child resistant packaging, prescription vials, prescription blisters, drug packaging