Child Passenger Seat SafetyNCT02242682
Video Education: Capitalizing on Caregiver Time Spent in the Pediatric Emergency Department Waiting Room
A study testing Child passenger safety video in people with Child Passenger Seat Safety, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The purpose of this study is to determine if video education is an effective means of caregiver education in the waiting room of a pediatric emergency department (ED). This will be tested with the showing of a child passenger safety video. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Child Passenger Seat Safety
- What is being tested?
- Child passenger safety video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Feb 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- caregivers of patients presenting to Children's Hospital of Wisconsin for treatment
- family use of automobile for transportation
Who cannot join
- non-English speaking caregivers
- triage level 1 or 2 or requiring immediate medical attention
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
The purpose of this study is to determine if video education is an effective means of caregiver education in the waiting room of a pediatric emergency department (ED). This will be tested with the showing of a child passenger safety video.
- Conditions
- Child Passenger Seat Safety
- Being tested
- Child passenger safety video
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Child passenger safety videoOther
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This group of subjects will not be exposed to a video during their time in the ED waiting room |
| Child passenger safety video | Experimental | This group of subjects will be exposed to a video during their time in the ED waiting room Receives: Other: Child passenger safety video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Difference in caregiver knowledge on a questionnaire
A knowledge questionnaire will be completed by caregivers in control and intervention groups
Measured: day 0 in the ED
Secondary outcomes (1)
Retention
A knowledge questionnaire for caregivers will be given at phone follow up 4 weeks after initial enrollment
Measured: up to 4 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Child Passenger Seat SafetyStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nina Muhammad, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242682
- Sponsor's protocol ID
- 527345
- Status last verified
- Jun 2015
- First submitted
- 2 Sep 2014
- Last updated
- 17 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wheeler JG, Fair M, Simpson PM, Rowlands LA, Aitken ME, Jacobs RF. Impact of a waiting room videotape message on parent attitudes toward pediatric antibiotic use. Pediatrics. 2001 Sep;108(3):591-6. doi: 10.1542/peds.108.3.591.
PubMed 11533323Dunn RA, Shenouda PE, Martin DR, Schultz AJ. Videotape increases parent knowledge about poliovirus vaccines and choices of polio vaccination schedules. Pediatrics. 1998 Aug;102(2):e26. doi: 10.1542/peds.102.2.e26.
PubMed 9685472Macy ML, Davis MM, Clark SJ, Stanley RM. Parental health literacy and asthma education delivery during a visit to a community-based pediatric emergency department: a pilot study. Pediatr Emerg Care. 2011 Jun;27(6):469-74. doi: 10.1097/PEC.0b013e31821c98a8.
PubMed 21629152Shenoi R, Saz EU, Jones JL, Ma L, Yusuf S. An emergency department intervention to improve knowledge of child passenger safety. Pediatr Emerg Care. 2010 Dec;26(12):881-7. doi: 10.1097/PEC.0b013e3181fe909f.
PubMed 21088639Schnellinger M, Finkelstein M, Thygeson MV, Vander Velden H, Karpas A, Madhok M. Animated video vs pamphlet: comparing the success of educating parents about proper antibiotic use. Pediatrics. 2010 May;125(5):990-6. doi: 10.1542/peds.2009-2916. Epub 2010 Apr 12.
PubMed 20385634Uherick L, Gorelick MH, Biechler R, Brixey SN, Melzer-Lange M. Validation of two child passenger safety questionnaires. Inj Prev. 2010 Oct;16(5):343-7. doi: 10.1136/ip.2009.022681. Epub 2010 Aug 30.
PubMed 20805618Durbin DR, Elliott MR, Winston FK. Belt-positioning booster seats and reduction in risk of injury among children in vehicle crashes. JAMA. 2003 Jun 4;289(21):2835-40. doi: 10.1001/jama.289.21.2835.
PubMed 12783914
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Education: Capitalizing on Caregiver Time Spent in the Pediatric Emergency Department Waiting Room
- ClinicalTrials.gov ID
- NCT02242682
- Acronym / sponsor ID
- 527345
- Conditions
- Child Passenger Seat Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 17 Sep 2014 (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.
The purpose of this study is to determine if video education is an effective means of caregiver education in the waiting room of a pediatric emergency department (ED). This will be tested with the showing of a child passenger safety video.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This group of subjects will not be exposed to a video during their time in the ED waiting room |
| Child passenger safety video | Experimental | Other: Child passenger safety videoThis group of subjects will be exposed to a video during their time in the ED waiting room |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- caregivers of patients presenting to Children's Hospital of Wisconsin for treatment
- family use of automobile for transportation
Key exclusion criteria (2 listed)
- non-English speaking caregivers
- triage level 1 or 2 or requiring immediate medical attention
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 |
|---|---|---|
| Child passenger safety video | Other | Child passenger safety video |
Primary outcome
Efficacy: Difference in caregiver knowledge on a questionnaire
Time frame: day 0 in the ED
A knowledge questionnaire will be completed by caregivers in control and intervention groups
1 secondary outcome
Retention
Time frame: up to 4 weeks after enrollment
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 17 Jun 2015.
- Background: PubMed 11533323Wheeler JG, Fair M, Simpson PM, Rowlands LA, Aitken ME, Jacobs RF. Impact of a waiting room videotape message on parent attitudes toward pediatric antibiotic use. Pediatrics. 2001 Sep;108(3):591-6. doi: 10.1542/peds.108.3.591.
- Background: PubMed 9685472Dunn RA, Shenouda PE, Martin DR, Schultz AJ. Videotape increases parent knowledge about poliovirus vaccines and choices of polio vaccination schedules. Pediatrics. 1998 Aug;102(2):e26. doi: 10.1542/peds.102.2.e26.
- Background: PubMed 21629152Macy ML, Davis MM, Clark SJ, Stanley RM. Parental health literacy and asthma education delivery during a visit to a community-based pediatric emergency department: a pilot study. Pediatr Emerg Care. 2011 Jun;27(6):469-74. doi: 10.1097/PEC.0b013e31821c98a8.
- Background: PubMed 21088639Shenoi R, Saz EU, Jones JL, Ma L, Yusuf S. An emergency department intervention to improve knowledge of child passenger safety. Pediatr Emerg Care. 2010 Dec;26(12):881-7. doi: 10.1097/PEC.0b013e3181fe909f.
- Background: PubMed 20385634Schnellinger M, Finkelstein M, Thygeson MV, Vander Velden H, Karpas A, Madhok M. Animated video vs pamphlet: comparing the success of educating parents about proper antibiotic use. Pediatrics. 2010 May;125(5):990-6. doi: 10.1542/peds.2009-2916. Epub 2010 Apr 12.
- Background: PubMed 20805618Uherick L, Gorelick MH, Biechler R, Brixey SN, Melzer-Lange M. Validation of two child passenger safety questionnaires. Inj Prev. 2010 Oct;16(5):343-7. doi: 10.1136/ip.2009.022681. Epub 2010 Aug 30.
- Background: PubMed 12783914Durbin DR, Elliott MR, Winston FK. Belt-positioning booster seats and reduction in risk of injury among children in vehicle crashes. JAMA. 2003 Jun 4;289(21):2835-40. doi: 10.1001/jama.289.21.2835.
- Related InfoLink 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Child passenger safety video in people with Child Passenger Seat Safety, run by Medical College of Wisconsin at 1 site 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 2 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 17 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Efficacy: Difference in caregiver knowledge on a questionnaire (time frame: day 0 in the ED). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02242682, which also lists 7 linked publications.
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 17 Jun 2015.