Clinical trial NCT01859780: Visual Distraction as a Means of Enhancing Child Resistance
Official title: Visual Distraction as a Means of Enhancing Child Resistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unintentional Ingestion of Prescriptions Within Vials and Blisters
Keywords: Poison control
Child resistant packaging
prescription vials
prescription blisters
drug packaging
Lead sponsor: Michigan State University
Sponsor class: OTHER
First posted: 2013-05-22
Enrollment: 229
Sex: ALL
Minimum age (years): 2
Maximum age (years): 54
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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)

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Lactose allergy or lactose sensitivity

Primary outcomes:
measure: Package selection
timeFrame: Day of experiment- Stage I
measure: Time to opening
timeFrame: Day of experiment (Stage II)
Secondary outcomes:
measure: Time to selection (continuous variable)
timeFrame: Day of the experiment- Stage I
measure: Success/Failure to open
timeFrame: Day of the experiment (Stage II)
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Packaging Building
state: Michigan
city: Howell
country: United States
facility: LESA Early Childhood Programs
state: Michigan
city: Toledo
country: United States
facility: Great Lakes Marketing
state: Ohio
Study officials:
affiliation: School of Packaging, Michigan State University
name: Laura Bix, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cognition and Cognitive Neuroscience Group
name: Mark Becker, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Knowledge in Development Lab, Psychology
name: Judith Danovitch, PhD
role: PRINCIPAL_INVESTIGATOR
References: