BehaviorPreschool_2NCT02934165
Safety Skills Training For Parents of Preschool Children
A study testing Family Safety 123 and AAP TIPP sheets in people with Behavior, run by Oregon Center for Applied Science, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior
- What is being tested?
- Family Safety 123 and AAP TIPP sheets
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Sep 2010
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Center for Applied Science
Eugene, Oregon, 97401
About this study
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.
Read the 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.
- Conditions
- Behavior
- Being tested
- Family Safety 123, AAP TIPP sheets
- Keywords
- child safety, injury, computer, prevention, internet
- Medical subject headings
- Behavior, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Safety 123Behavioural
Also called Family Safety 123 for Parents of Children 2-5
Theoretically-based injury prevention videos for families
AAP TIPP sheetsBehavioural
American Academy of Pediatrics The Injury Prevent Program materials converted to web-based materials.
| Study group | Role | What they receive |
|---|---|---|
| Family Safety 123 | Experimental | Parents viewed a website with videos on child injury prevention strategies and received emails for 30 days inviting them to view additional videos. Receives: Behavioral: Family Safety 123 |
| AAP TIPP sheets | Active comparator | Parents viewed online injury prevention materials developed by the American Academy of Pediatrics and had continuing access to these materials for 30 days. Receives: Behavioral: AAP TIPP sheets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral measure: Change from baseline in identification of correct/incorrect child car safety seat and booster seat situations and bicycle helmet placement situations.
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.
Measured: 30 days and 60 days
Secondary outcomes (9)
Change in knowledge of injury prevention strategies
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.
Measured: 30 days and 60 days
Change in attitudes and beliefs about injury prevention strategies
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.
Measured: 30 days and 60 days
Change in self-efficacy for engaging in injury prevention strategies
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.
Measured: 30 days and 60 days
Change in car safety knowledge of injury prevention
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.
Measured: 30 days and 60 days
Change in car safety attitudes & beliefs of injury prevention
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.
Measured: 30 days and 60 days
Change in car safety self-efficacy in performing injury prevention skills
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.
Measured: 30 days and 60 days
Change in wheeled sports knowledge of injury prevention
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.
Measured: 30 days and 60 days
Change in wheeled sports attitudes & beliefs of injury prevention
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.
Measured: 30 days and 60 days
Change in wheeled sports self-efficacy in performing injury prevention skills
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.
Measured: 30 days and 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startSep 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BehaviorStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 151 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
- NCT02934165
- Sponsor's protocol ID
- SBIR72RR-2
- Other IDs
- R44HD047068
- Acronym
- Preschool_2
- Status last verified
- Oct 2016
- First submitted
- 30 Dec 2014
- Last updated
- 14 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 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Skills Training For Parents of Preschool Children
- ClinicalTrials.gov ID
- NCT02934165
- Acronym / sponsor ID
- Preschool_2 / SBIR72RR-2
- Conditions
- Behavior
- Keywords
- child safety, injury, computer, prevention, internet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 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
- Sep 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 14 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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Safety 123 | Experimental | Behavioral: Family Safety 123Parents viewed a website with videos on child injury prevention strategies and received emails for 30 days inviting them to view additional videos. |
| AAP TIPP sheets | Active comparator | Behavioral: AAP TIPP sheetsParents viewed online injury prevention materials developed by the American Academy of Pediatrics and had continuing access to these materials for 30 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Family Safety 123Also: Family Safety 123 for Parents of Children 2-5Theoretically-based injury prevention videos for families | Behavioural | Family Safety 123 |
| AAP TIPP sheetsAmerican Academy of Pediatrics The Injury Prevent Program materials converted to web-based materials. | Behavioural | AAP TIPP sheets |
Primary outcome
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.
9 secondary outcomes
Change in knowledge of injury prevention strategies
Time frame: 30 days and 60 days
Change in attitudes and beliefs about injury prevention strategies
Time frame: 30 days and 60 days
Change in self-efficacy for engaging in injury prevention strategies
Time frame: 30 days and 60 days
Change in car safety knowledge of injury prevention
Time frame: 30 days and 60 days
Change in car safety attitudes & beliefs of injury prevention
Time frame: 30 days and 60 days
Change in car safety self-efficacy in performing injury prevention skills
Time frame: 30 days and 60 days
Change in wheeled sports knowledge of injury prevention
Time frame: 30 days and 60 days
Change in wheeled sports attitudes & beliefs of injury prevention
Time frame: 30 days and 60 days
Change in wheeled sports self-efficacy in performing injury prevention skills
Time frame: 30 days and 60 days
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 14 Oct 2016.
- Individual participant dataSharing planned: No
Related trials for Behavior
Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
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 study testing Family Safety 123 and AAP TIPP sheets in people with Behavior, 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 1 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 14 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.
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?
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). 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 14 Oct 2016.