Unintentional Ingestion of Prescriptions Within Vials and BlistersVDCRNCT01859780
Visual Distraction as a Means of Enhancing Child Resistance
A study testing Visual distractor in people with Unintentional Ingestion of Prescriptions Within Vials and Blisters, run by Michigan State University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years to 54 monthsHealthy volunteers can take part
- Conditions the study is for
- Unintentional Ingestion of Prescriptions Within Vials and Blisters
- What is being tested?
- Visual distractor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2013to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years to 54 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 2-4.5 years of age
- Parental permission to video tape
Who cannot join
- Lactose allergy or lactose sensitivity
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Packaging Building
East Lansing, Michigan, 48824
LESA Early Childhood Programs
Howell, Michigan, 48843
Great Lakes Marketing
Toledo, Ohio, 43606
About this study
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.
Read more
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.
Read the 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)
- Being tested
- Visual distractor
- Keywords
- Poison control, Child resistant packaging, prescription vials, prescription blisters, drug packaging
- Medical subject headings
- Blister
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual distractorOther
| Study group | Role | What they receive |
|---|---|---|
| Prescription packages (vials and blisters) | Experimental | 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. Receives: Other: Visual distractor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Package selection
Selection of one of three treatments in stage one testing (categorical variable)
Measured: Day of experiment- Stage I
Time to opening
Time it takes a participant to successfully open a given treatment (continuous variable)
Measured: Day of experiment (Stage II)
Secondary outcomes (2)
Time to selection (continuous variable)
Time it takes participants to select package (continuous variable)
Measured: Day of the experiment- Stage I
Success/Failure to open
Success or failure in opening by package treatment (binary response variable)
Measured: Day of the experiment (Stage II)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startAug 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unintentional Ingestion of Prescriptions Within Vials and BlistersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Bix, Michigan State University
- Investigators
- Laura Bix, PhD, Principal investigator, School of Packaging, Michigan State UniversityMark Becker, PhD, Principal investigator, Cognition and Cognitive Neuroscience GroupJudith Danovitch, PhD, Principal investigator, Knowledge in Development Lab, Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859780
- Sponsor's protocol ID
- 13-246
- Acronym
- VDCR
- Status last verified
- May 2024
- First submitted
- 1 May 2013
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Distraction as a Means of Enhancing Child Resistance
- ClinicalTrials.gov ID
- NCT01859780
- Acronym / sponsor ID
- VDCR / 13-246
- Keywords
- Poison control, Child resistant packaging, prescription vials, prescription blisters, drug packaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 22 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prescription packages (vials and blisters) | Experimental | Other: Visual distractorStage 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. |
Who may qualify
- Ages
- 2 years to 54 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 2-4.5 years of age
- Parental permission to video tape
Key exclusion criteria (1 listed)
- Lactose allergy or lactose sensitivity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual distractor | Other | Prescription packages (vials and blisters) |
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)
2 secondary outcomes
Time to selection (continuous variable)
Time frame: Day of the experiment- Stage I
Success/Failure to open
Time frame: Day of the experiment (Stage II)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Protect and Protect Rx InitiativesLink provided by the sponsor.
- Up and Away Campaign (brochures from this campaign will be sent home with children after testing)Link provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Bix, PhD principal investigator
School of Packaging, Michigan State University
Mark Becker, PhD principal investigator
Cognition and Cognitive Neuroscience Group
Judith Danovitch, PhD principal investigator
Knowledge in Development Lab, Psychology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual distractor in people with Unintentional Ingestion of Prescriptions Within Vials and Blisters, run by Michigan State University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Package selection (time frame: Day of experiment- Stage I). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.