Injury PreventionNCT01432041
Brief Child Safety Interventions in Emergency Departments (Safety in Seconds)
A study testing tailored health education in people with Injury Prevention, run by Johns Hopkins Bloomberg School of Public Health.
Trial summary
Safety in seconds is a randomized controlled trial of a computer tailored Injury Prevention program which was conducted in the waiting area of a level 1 pediatric trauma center. A computer kiosk was used to randomly assign participants to study groups, collect baseline data and generate tailored reports based on… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Injury Prevention
- What is being tested?
- tailored health education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 901 participants
- Where
- No sites listed yet
- Study dates
- Sep 2004to Dec 2005
- 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
- Eligible parents or guardians had to be English-speaking;
- have a child between 4-66 months of age seeking treatment for an injury or medical complaint, or have an age-appropriate sibling of a child being seen for these reasons;
- live in Baltimore City;
- and live with the child at least some of the time.
Who cannot join
- -parents which did not meet inclusion criteria
About this study
Safety in seconds is a randomized controlled trial of a computer tailored Injury Prevention program which was conducted in the waiting area of a level 1 pediatric trauma center. A computer kiosk was used to randomly assign participants to study groups, collect baseline data and generate tailored reports based on responses to assessment items. An intervention group received a personalized and stage-tailored safety report and a control group received a personalized, but otherwise generic report on other child health topics. Telephone follow-up interviews were conducted 2-4 weeks and again 4-6 months after enrollment. Home visits were completed for a subset (n=100) of parents who completed the 4-6 month follow-up interview. The study aimed to increase knowledge, self reported and observed safety behaviors.
- Conditions
- Injury Prevention
- Being tested
- tailored health education
- Keywords
- Injury prevention, smoke alarms, car seats
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tailored health educationBehavioural
Also called Tailored health Communication
Health Information via a computer kiosk in the pediatric emergency department
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge outcome
Measures of Home safety Knowledge
Reported and Observed Home Safety behaviors
Reportedf and Observed Home Safety Behaviors (Car Seats, Smoke Alarms)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2011 (estimated)
- Study startSep 2004
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Injury PreventionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe 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
- Primary purpose
- Prevention
- Enrolment
- 901 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea C Gielen, ScD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01432041
- Sponsor's protocol ID
- JHSPH-H.31.02.04.03.B2
- Status last verified
- Sep 2011
- First submitted
- 8 Sep 2011
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Gielen AC, McKenzie LB, McDonald EM, Shields WC, Wang MC, Cheng YJ, Weaver NL, Walker AR. Using a computer kiosk to promote child safety: results of a randomized, controlled trial in an urban pediatric emergency department. Pediatrics. 2007 Aug;120(2):330-9. doi: 10.1542/peds.2006-2703.
PubMed 17671059
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Child Safety Interventions in Emergency Departments (Safety in Seconds)
- ClinicalTrials.gov ID
- NCT01432041
- Acronym / sponsor ID
- JHSPH-H.31.02.04.03.B2
- Conditions
- Injury Prevention
- Keywords
- Injury prevention, smoke alarms, car seats
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 901 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 12 Sep 2011 (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.
Safety in seconds is a randomized controlled trial of a computer tailored Injury Prevention program which was conducted in the waiting area of a level 1 pediatric trauma center. A computer kiosk was used to randomly assign participants to study groups, collect baseline data and generate tailored reports based on responses to assessment items. An intervention group received a personalized and stage-tailored safety report and a control group received a personalized, but otherwise generic report on other child health topics. Telephone follow-up interviews were conducted 2-4 weeks and again 4-6 months after enrollment. Home visits were completed for a subset (n=100) of parents who completed the 4-6 month follow-up interview. The study aimed to increase knowledge, self reported and observed safety behaviors.
Study design
- Primary purpose
- Prevention
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Eligible parents or guardians had to be English-speaking;
- have a child between 4-66 months of age seeking treatment for an injury or medical complaint, or have an age-appropriate sibling of a child being seen for these reasons;
- live in Baltimore City;
- and live with the child at least some of the time.
Key exclusion criteria (1 listed)
- -parents which did not meet inclusion criteria
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 |
|---|---|---|
| tailored health educationAlso: Tailored health CommunicationHealth Information via a computer kiosk in the pediatric emergency department | Behavioural | – |
Primary outcome
Knowledge outcome
Measures of Home safety Knowledge
Reported and Observed Home Safety behaviors
Reportedf and Observed Home Safety Behaviors (Car Seats, Smoke Alarms)
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 22 Mar 2023.
- Background: PubMed 17671059Gielen AC, McKenzie LB, McDonald EM, Shields WC, Wang MC, Cheng YJ, Weaver NL, Walker AR. Using a computer kiosk to promote child safety: results of a randomized, controlled trial in an urban pediatric emergency department. Pediatrics. 2007 Aug;120(2):330-9. doi: 10.1542/peds.2006-2703.
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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.
Andrea C Gielen, ScD principal investigator
Johns Hopkins Bloomberg School of Public Health
Questions about this trial
What is this clinical trial studying?
A study testing tailored health education in people with Injury Prevention, run by Johns Hopkins Bloomberg School of Public Health.
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 4 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 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Knowledge outcome. 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?
On the ClinicalTrials.gov record for NCT01432041, which also lists 1 linked publication.
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 22 Mar 2023.