InjuryPhase 2BabySafety_2NCT02934633
Parent Training in Child Safety Practices
A Phase 2 study testing Keeping Baby Safe 2-DVD package and The Injury Prevention Program (TIPP) sheets in people with Injury, run by Oregon Center for Applied Science, Inc. at 1 site in United States.
Trial summary
This project completed an intervention designed to teach parents of children aged 0-2 years of age how to prevent injuries to their child. The intervention consisted of a two DVD package with information on creating a safe home environment and correctly choosing and installing an appropriate car safety seat. Read more about this study
- Who is it for?
- Ages 13 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Injury
- What is being tested?
- Keeping Baby Safe 2-DVD package and The Injury Prevention Program (TIPP) sheets
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 414 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Aug 2008
- Phase
- Phase 2
- 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 13 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 18 years or older
- Parent whose oldest child is 0-24 months old
- Speak and read English
- Have internet access (online study only)
Who cannot join
- Parents who do not have legal or physical custody
- Subjects live in a household in which a family member had an overnight stay in the hospital as a result of an injury in the last 2 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Center for Applied Science
Eugene, Oregon, 97401
About this study
This project completed an intervention designed to teach parents of children aged 0-2 years of age how to prevent injuries to their child. The intervention consisted of a two DVD package with information on creating a safe home environment and correctly choosing and installing an appropriate car safety seat. The study hypothesis was that parents who used the intervention would score significantly higher on measures of knowledge, motivation, intention and self-efficacy in implementing injury prevention strategies.
- Conditions
- Injury
- Being tested
- Keeping Baby Safe 2-DVD package, The Injury Prevention Program (TIPP) sheets
- Keywords
- injury, child, cars, pedestrians, child safety, interactive, computer, prevention, internet, CD-ROM
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Keeping Baby Safe 2-DVD packageBehavioural
Keeping Baby Safe is a 2-DVD package that teaches childhood injury prevention skills to parents of children from birth to 24 months of age. One DVD addresses automobile passenger safety and focuses on the correct choice and proper installation of child safety seat for the age of the parent's child. The second DVD covers a core set of home safety skills: (a) preventing falls, (b) preventing fires and burns, (c) preventing poisoning, (d) firearm safety, (e) preventing drowning, (f) preventing suffocation and choking, (e) play equipment safety, and (f) animal safety. Content in the home safety DVD is based on information the American Academy of Pediatrics (AAP) recommends that physicians provide to parents during well-baby visits.
The Injury Prevention Program (TIPP) sheetsBehavioural
American Academy of Pediatrics The Injury Prevention Program (TIPP) sheets. Paper-based information sheets parents would typically receive from their pediatrician or general practitioner at well-baby visits.
| Study group | Role | What they receive |
|---|---|---|
| Keeping Baby Safe | Experimental | Keeping Baby Safe 2-DVD package, designed for parents of children from birth to 24 months. One DVD addresses automobile passenger safety and focuses on the correct choice and proper installation of child safety seat for the age of the parent's child. The second DVD covers a core set of home safety skills: (a) preventing falls, (b) preventing fires and burns, (c) preventing poisoning, (d) firearm safety, (e) preventing drowning, (f) preventing suffocation and choking, (e) play equipment safety, and (f) animal safety. Content in the home safety DVD is based on information the American Academy of Pediatrics (AAP) recommends that physicians provide to parents during well-baby visits. Receives: Behavioral: Keeping Baby Safe 2-DVD package |
| AAP TIPP Sheets | Active comparator | American Academy of Pediatrics The Injury Prevention Program (TIPP) sheets. Paper-based information sheets that parents would typically receive from their pediatrician or general practitioner at well-baby visits. Receives: Behavioral: The Injury Prevention Program (TIPP) sheets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in parent motivation to implement injury prevention strategies
Measured: 7 day and 30 day post intervention
Change in parent knowledge of injury prevention practices
Measured: 7 and 30 day post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startAug 2006
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InjuryStudies 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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 414 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Center for Applied Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Lynne H Grilley Swartz, MPH, CHES, Principal investigator, Oregon Center for Applied Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934633
- Sponsor's protocol ID
- SBIR 63-2
- Other IDs
- R44HD044281
- Acronym
- BabySafety_2
- Status last verified
- Oct 2016
- First submitted
- 31 May 2013
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent Training in Child Safety Practices
- ClinicalTrials.gov ID
- NCT02934633
- Acronym / sponsor ID
- BabySafety_2 / SBIR 63-2
- Conditions
- Injury
- Keywords
- injury, child, cars, pedestrians, child safety, interactive, computer, prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 414 participants (actual)
- Lead sponsor
- Oregon Center for Applied Science, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Aug 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 17 Oct 2016 (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.
This project completed an intervention designed to teach parents of children aged 0-2 years of age how to prevent injuries to their child. The intervention consisted of a two DVD package with information on creating a safe home environment and correctly choosing and installing an appropriate car safety seat. The study hypothesis was that parents who used the intervention would score significantly higher on measures of knowledge, motivation, intention and self-efficacy in implementing injury prevention strategies.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Keeping Baby Safe | Experimental | Behavioral: Keeping Baby Safe 2-DVD packageKeeping Baby Safe 2-DVD package, designed for parents of children from birth to 24 months. One DVD addresses automobile passenger safety and focuses on the correct choice and proper installation of child safety seat for the age of the parent's child. The second DVD covers a core set of home safety skills: (a) preventing falls, (b) preventing fires and burns, (c) preventing poisoning, (d) firearm safety, (e) preventing drowning, (f) preventing suffocation and choking, (e) play equipment safety, and (f) animal safety. Content in the home safety DVD is based on information the American Academy of Pediatrics (AAP) recommends that physicians provide to parents during well-baby visits. |
| AAP TIPP Sheets | Active comparator | Behavioral: The Injury Prevention Program (TIPP) sheetsAmerican Academy of Pediatrics The Injury Prevention Program (TIPP) sheets. Paper-based information sheets that parents would typically receive from their pediatrician or general practitioner at well-baby visits. |
Who may qualify
- Ages
- 13 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- Parent whose oldest child is 0-24 months old
- Speak and read English
- Have internet access (online study only)
Key exclusion criteria (2 listed)
- Parents who do not have legal or physical custody
- Subjects live in a household in which a family member had an overnight stay in the hospital as a result of an injury in the last 2 years
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 |
|---|---|---|
| Keeping Baby Safe 2-DVD packageKeeping Baby Safe is a 2-DVD package that teaches childhood injury prevention skills to parents of children from birth to 24 months of age. One DVD addresses automobile passenger safety and focuses on the correct choice and proper installation of child safety seat for the age of the parent's child. The second DVD covers a core set of home safety skills: (a) preventing falls, (b) preventing fires and burns, (c) preventing poisoning, (d) firearm safety, (e) preventing drowning, (f) preventing suffocation and choking, (e) play equipment safety, and (f) animal safety. Content in the home safety DVD is based on information the American Academy of Pediatrics (AAP) recommends that physicians provide to parents during well-baby visits. | Behavioural | Keeping Baby Safe |
| The Injury Prevention Program (TIPP) sheetsAmerican Academy of Pediatrics The Injury Prevention Program (TIPP) sheets. Paper-based information sheets parents would typically receive from their pediatrician or general practitioner at well-baby visits. | Behavioural | AAP TIPP Sheets |
Primary outcome
Change in parent motivation to implement injury prevention strategies
Time frame: 7 day and 30 day post intervention
Change in parent knowledge of injury prevention practices
Time frame: 7 and 30 day post intervention
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 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Lynne H Grilley Swartz, MPH, CHES principal investigator
Oregon Center for Applied Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Keeping Baby Safe 2-DVD package and The Injury Prevention Program (TIPP) sheets in people with Injury, run by Oregon Center for Applied Science, Inc. 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 4 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 Oct 2016. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in parent motivation to implement injury prevention strategies (time frame: 7 day and 30 day post intervention). 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 17 Oct 2016.