- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02934165
Safety Skills Training For Parents of Preschool Children (Preschool_2)
October 12, 2016 updated by: Oregon Center for Applied Science, Inc.
As the leading cause of death and disability in children in America, unintentional injuries are a critical public health issue.
Most injuries can be prevented by parents implementing effective child safety practices.
This project produced an interactive multimedia (IMM) program delivered via Internet/Intranet that taught injury prevention skills to parents of children aged 2 through 5 years, with the ultimate goal of reducing mortality and disability from unintentional injury in this population.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This project produced a comprehensive, interactive multimedia (IMM) program called Family Safety 123 to teach childhood injury prevention skills to parents of children 2 to 5 years of age.
The program contained 40 high-quality video clips, each 2 to 5 minutes in length, depicting injury prevention strategies in 13 content areas: supervision, preventing airway obstructions, poison awareness, preventing burns, preventing falls, firearm safety, motor vehicle safety, pedestrian awareness, sports, playgrounds, water safety, bike safety, and other safety concerns.
Each content area contained 1 to 6 videos comprised of short video presentations, modeling vignettes demonstrating desired behaviors, supportive testimonials, and suggestions for modifications to home and recreational environments.
Family Safety 123 video content is derived from The Injury Prevention Program (TIPP) sheets developed by the American Academy of Pediatrics, which recognizes injury prevention as a primary topic for parents.
Study Type
Interventional
Enrollment (Actual)
151
Phase
- Not Applicable
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
-
-
Oregon
-
Eugene, Oregon, United States, 97401
- Oregon Center for Applied Science
-
-
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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Parents of children aged 2-5 potentially were as young as 18 years old. Parents or legal guardians could potentially be as old as 65 or older.
Exclusion Criteria:
- Only English-speaking participants were accepted because the program was developed only for English speakers. All English-speaking parents of children aged 2-5 years old who wished to participate were included. Online Survey: parents under 18 years of age were excluded because we were unable to obtain parental consent online.
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
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Family Safety 123
Parents viewed a website with videos on child injury prevention strategies and received emails for 30 days inviting them to view additional videos.
|
Theoretically-based injury prevention videos for families
Other Names:
|
|
Active Comparator: AAP TIPP sheets
Parents viewed online injury prevention materials developed by the American Academy of Pediatrics and had continuing access to these materials for 30 days.
|
American Academy of Pediatrics The Injury Prevent Program materials converted to web-based materials.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Behavioral measure: Change from baseline in identification of correct/incorrect child car safety seat and booster seat situations and bicycle helmet placement situations.
Time Frame: 30 days and 60 days
|
Parents viewed child car seat and booster seat situations and were asked whether 9 car safety seat and 7 booster seat items were correct or incorrect.
Parents also viewed 2 bicycle helmet situations and were asked to identify if these were correct or incorrect.
|
30 days and 60 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in knowledge of injury prevention strategies
Time Frame: 30 days and 60 days
|
An injury prevention knowledge scale was created across all content areas.
The injury prevention knowledge scale contained 41 items (e.g., "The best way to lessen the possibility of a young child choking …") for parents of younger children and 44-items for parents of older children.
The injury prevention knowledge scale represents the percent of items correctly endorsed.
|
30 days and 60 days
|
|
Change in attitudes and beliefs about injury prevention strategies
Time Frame: 30 days and 60 days
|
An injury prevention attitudes & beliefs scale was created across all content areas (e.g., "It is never ok to use a second hand car seat even if you know the car seat has never been involved in a crash.").
Thirty-four items assessed attitudes & beliefs for parents of younger children and 33-items for parents of older children (alpha = .85
for both younger and older children).
All items were assessed using a 5-point Likert scale with 1 = strongly disagree to 5 = strongly agree.
|
30 days and 60 days
|
|
Change in self-efficacy for engaging in injury prevention strategies
Time Frame: 30 days and 60 days
|
An injury prevention self-efficacy scale was created from 36 items across all content areas for the parents of younger children and 35 items for parents of older (e.g., "I am confident that I know the safest way to store guns and ammunition") (alpha = .77
for younger children and .89
for older children.)
All items were assessed using a 5-point Likert scale with 1 = strongly disagree to 5 = strongly agree.
|
30 days and 60 days
|
|
Change in car safety knowledge of injury prevention
Time Frame: 30 days and 60 days
|
Three items were used to assess knowledge of car safety injury prevention (e.g., "Your child should use a forward-facing safety seat until…") with the response coded as either 0 = incorrect or 1 = correct.
|
30 days and 60 days
|
|
Change in car safety attitudes & beliefs of injury prevention
Time Frame: 30 days and 60 days
|
Two items were used to assess attitudes and beliefs towards car safety injury prevention (e.g., "It is never ok to use a second car seat even if you know the car seat has never been involved in a crash").
Both items were assessed with a 5-point Likert scale with 1 = strongly disagree and 5 = strongly agree.
Both of the attitudes & beliefs items for the car safety attitudes content area were discarded because the wording proved confusing to participants.
|
30 days and 60 days
|
|
Change in car safety self-efficacy in performing injury prevention skills
Time Frame: 30 days and 60 days
|
Four items were used to assess self-efficacy in performing car safety injury prevention skills (e.g., "How confident are you that you know when to transition your child into a booster seat?").
Items were assessed with a 5-point Likert scale with 1 = not at all confident and 5 = extremely confident.
|
30 days and 60 days
|
|
Change in wheeled sports knowledge of injury prevention
Time Frame: 30 days and 60 days
|
Two items were used to assess knowledge of wheeled sports injury prevention (e.g., "A child carrier bike seat should…") with the response coded as either 0 = incorrect or 1 = correct.
|
30 days and 60 days
|
|
Change in wheeled sports attitudes & beliefs of injury prevention
Time Frame: 30 days and 60 days
|
Four items were used to assess attitudes & beliefs towards wheeled sports safety injury prevention (e.g., "It is extremely important for my child to wear a helmet whenever riding his or her bike").
Items were assessed with a 5-point Likert scale with 1 = strongly disagree and 5 = strongly agree.
|
30 days and 60 days
|
|
Change in wheeled sports self-efficacy in performing injury prevention skills
Time Frame: 30 days and 60 days
|
Three items were used to assess self-efficacy in performing wheeled sports injury prevention skills (e.g., "How confident are you that you know how to correctly check the fit of your child's helmet?").
Items were assessed with a 5-point Likert scale with 1 = not at all confident and 5 = extremely confident.
|
30 days and 60 days
|
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
September 1, 2009
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
December 30, 2014
First Submitted That Met QC Criteria
October 12, 2016
First Posted (Estimate)
October 14, 2016
Study Record Updates
Last Update Posted (Estimate)
October 14, 2016
Last Update Submitted That Met QC Criteria
October 12, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SBIR72RR-2
- R44HD047068 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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