Visual Distraction as a Means of Enhancing Child Resistance (VDCR)
Primary Purpose
Unintentional Ingestion of Drugs Contained Within Prescription Vials and Blisters.
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Visual distractor
Sponsored by
About this trial
This is an interventional basic science trial for Unintentional Ingestion of Drugs Contained Within Prescription Vials and Blisters. focused on measuring Poison control, Child resistant packaging, prescription vials, prescription blisters, drug packaging
Eligibility Criteria
Inclusion Criteria:
- 2-4.5 years of age
- Parental permission to video tape
Exclusion Criteria:
- Lactose allergy or lactose sensitivity
Sites / Locations
- Packaging Building
- LESA Early Childhood Programs
- Great Lakes Marketing
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prescription packages (vials and blisters)
Arm Description
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.
Outcomes
Primary Outcome Measures
Package selection
Selection of one of three treatments in stage one testing (categorical variable)
Time to opening
Time it takes a participant to successfully open a given treatment (continuous variable)
Secondary Outcome Measures
Time to selection (continuous variable)
Time it takes participants to select package (continuous variable)
Success/Failure to open
Success or failure in opening by package treatment (binary response variable)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01859780
Brief Title
Visual Distraction as a Means of Enhancing Child Resistance
Acronym
VDCR
Official Title
Visual Distraction as a Means of Enhancing Child Resistance
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unintentional Ingestion of Drugs Contained Within Prescription Vials and Blisters.
Keywords
Poison control, Child resistant packaging, prescription vials, prescription blisters, drug packaging
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
229 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prescription packages (vials and blisters)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Visual distractor
Primary Outcome Measure Information:
Title
Package selection
Description
Selection of one of three treatments in stage one testing (categorical variable)
Time Frame
Day of experiment- Stage I
Title
Time to opening
Description
Time it takes a participant to successfully open a given treatment (continuous variable)
Time Frame
Day of experiment (Stage II)
Secondary Outcome Measure Information:
Title
Time to selection (continuous variable)
Description
Time it takes participants to select package (continuous variable)
Time Frame
Day of the experiment- Stage I
Title
Success/Failure to open
Description
Success or failure in opening by package treatment (binary response variable)
Time Frame
Day of the experiment (Stage II)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
54 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
2-4.5 years of age
Parental permission to video tape
Exclusion Criteria:
Lactose allergy or lactose sensitivity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Bix, PhD
Organizational Affiliation
School of Packaging, Michigan State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Becker, PhD
Organizational Affiliation
Cognition and Cognitive Neuroscience Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Judith Danovitch, PhD
Organizational Affiliation
Knowledge in Development Lab, Psychology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Packaging Building
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Facility Name
LESA Early Childhood Programs
City
Howell
State/Province
Michigan
ZIP/Postal Code
48843
Country
United States
Facility Name
Great Lakes Marketing
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.cdc.gov/MedicationSafety/protect/protect_Initiative.html
Description
Protect and Protect Rx Initiatives
URL
http://www.upandaway.org/
Description
Up and Away Campaign (brochures from this campaign will be sent home with children after testing)
Learn more about this trial
Visual Distraction as a Means of Enhancing Child Resistance
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