- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02329340
Safety Skills Training: Parents of School-Aged Children (SAS_2)
December 29, 2014 updated by: Susan Schroeder, Oregon Center for Applied Science, Inc.
Injuries are the leading cause of death and disability in children in America.
Most injuries can be prevented when parents implement effective child safety practices.
This project will create a behaviorally based program to teach parents what to do to prevent injuries to their school aged child, in an effort to reduce the number of injuries, hospitalizations, medical costs, and missed work days.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This project will produce a comprehensive, interactive multimedia (IMM) program to teach childhood injury prevention skills to parents of children 6 through 11 years of age.
This is one of a four-part series of funded programs to address injury prevention issues for three age groups of children (birth through 24 months, 2-5 years of age and 6-11 years of age).
The program will be created in three formats: Internet/intranet, CD-ROM, and linear video (DVD) suitable for use in homes, worksites, medical settings, service agencies, and health information Web sites.
On-screen narrators will guide the user through program material comprised of short video presentations, modeling vignettes demonstrating desired behaviors, supportive testimonials, and suggestions for modifications to home and recreational environments.
Study Type
Interventional
Enrollment (Actual)
175
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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The basic lower age limit for parents or guardians of children aged 6-11 for this study was 18. 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 or guardians living in the U.S., with children aged 6-11 years old, who wished to participate were included. Parents under 18 were excluded from this online study because parental consent cannot be obtained 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 |
---|---|
Active Comparator: Am Academy of Pediatrics print materials
In-person session to read online version of American Academy of Pediatrics The Injury Prevention Program (TIPP sheets) childhood injury prevention print materials, followed by access to the TIPP sheets for 30 days.
|
Print materials of injury prevention content.
Other Names:
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Experimental: Family Safety 1-2-3
In-person session to view video and text-based interactive web site on injury prevention information and strategies, followed by 8 emails delivered over a 30-day period inviting participant to view additional child safety videos.
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Theoretically based school-aged childhood injury prevention videos for families
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behavioral measure: identification of correct/incorrect car booster safety seat, seat belt, and bicycle helmet placement
Time Frame: Immediate posttest and 30-day follow-up
|
Parents viewed 2 car seat installations and were asked whether 7 car booster safety seat situations (e.g., age of the child for the seat) and 7 seat belt installations (e.g., placement of the seat belt) were correct or incorrect.
Parents also viewed a bicycle helmet on a dummy and were asked to identify whether 2 helmet situations were correct or incorrect.
|
Immediate posttest and 30-day follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knowledge of injury prevention strategies
Time Frame: immediate posttest and 30-day follow-up
|
An injury prevention knowledge scale was created across all content areas.
The injury prevention knowledge scale contained 39 items (e.g., "To prevent scald injuries, hot water heaters should be set to …") for all age groups.
The injury prevention knowledge scale represented the percent of items correctly endorsed.
|
immediate posttest and 30-day follow-up
|
Attitudes and beliefs about injury prevention strategies
Time Frame: immediate posttest and 30-day follow-up
|
An injury prevention attitudes & beliefs scale was created across all content areas (e.g., "A family emergency plan is extremely important strategy to keep your family safe in case of a fire.").
Twenty-five items assessed attitudes & beliefs for the 6-9 year age group and 24-items the 10-11 age group (alpha = .81
for both younger and older children).
All items were assessed using a 5-point Likert scale with 1 = strongly disagree to 5 = strongly agree.
|
immediate posttest and 30-day follow-up
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Self-efficacy for engaging in injury prevention strategies
Time Frame: immediate posttest and 30-day follow-up
|
An injury prevention self-efficacy scale was created from 29 items across all content areas for all age groups (e.g., "How confident are you that you know how to test the temperature of your water heater?")
(alpha = .91
for all age groups) All items were assessed using a 5-point Likert scale with 1 = strongly disagree to 5 = strongly agree.
|
immediate posttest and 30-day follow-up
|
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)
August 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
December 29, 2014
First Submitted That Met QC Criteria
December 29, 2014
First Posted (Estimate)
December 31, 2014
Study Record Updates
Last Update Posted (Estimate)
December 31, 2014
Last Update Submitted That Met QC Criteria
December 29, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SBIR76R-2
- R44HD048005 (U.S. NIH Grant/Contract)
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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