- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02934633
Parent Training in Child Safety Practices (BabySafety_2)
October 13, 2016 updated by: Oregon Center for Applied Science, Inc.
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
414
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oregon
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Eugene, Oregon, United States, 97401
- Oregon Center for Applied Science
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 65 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years or older
- Parent whose oldest child is 0-24 months old
- Speak and read English
- Have internet access (online study only)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Keeping Baby Safe
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.
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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.
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Active Comparator: AAP TIPP Sheets
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in parent motivation to implement injury prevention strategies
Time Frame: 7 day and 30 day post intervention
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7 day and 30 day post intervention
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Change in parent knowledge of injury prevention practices
Time Frame: 7 and 30 day post intervention
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7 and 30 day post intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
May 31, 2013
First Submitted That Met QC Criteria
October 13, 2016
First Posted (Estimate)
October 17, 2016
Study Record Updates
Last Update Posted (Estimate)
October 17, 2016
Last Update Submitted That Met QC Criteria
October 13, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- SBIR 63-2
- R44HD044281 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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