InjuriesPhase 2SAS_2NCT02329340
Safety Skills Training: Parents of School-Aged Children
A Phase 2 study testing Am Academy of Pediatrics print materials and Family safety 1-2-3 in people with Injuries, run by Oregon Center for Applied Science, Inc. at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Injuries
- What is being tested?
- Am Academy of Pediatrics print materials and Family safety 1-2-3
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Aug 2010
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Center for Applied Science
Eugene, Oregon, 97401
About this study
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.
Read the 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.
- Conditions
- Injuries
- Being tested
- Am Academy of Pediatrics print materials, Family safety 1-2-3
- Keywords
- child safety, injury, prevention, computer, internet
- 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.
Am Academy of Pediatrics print materialsBehavioural
Also called The Injury Prevention Program; tip sheets
Print materials of injury prevention content.
Family safety 1-2-3Behavioural
Theoretically based school-aged childhood injury prevention videos for families
| Study group | Role | What they receive |
|---|---|---|
| Am Academy of Pediatrics print materials | Active comparator | 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. Receives: Behavioral: Am Academy of Pediatrics print materials |
| Family Safety 1-2-3 | Experimental | 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. Receives: Behavioral: Family safety 1-2-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral measure: identification of correct/incorrect car booster safety seat, seat belt, and bicycle helmet placement
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.
Measured: Immediate posttest and 30-day follow-up
Secondary outcomes (3)
Knowledge of injury prevention strategies
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.
Measured: immediate posttest and 30-day follow-up
Attitudes and beliefs about injury prevention strategies
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.
Measured: immediate posttest and 30-day follow-up
Self-efficacy for engaging in injury prevention strategies
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.
Measured: immediate posttest and 30-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startSep 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InjuriesStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 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
- Principal investigator, Susan Schroeder, Oregon Center for Applied Science, Inc.
- Investigators
- Lynne H Grilley Swartz, MPH, CHES, Principal investigator, Oregon Center for Applied Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329340
- Sponsor's protocol ID
- SBIR76R-2
- Other IDs
- R44HD048005
- Acronym
- SAS_2
- Status last verified
- Dec 2014
- First submitted
- 29 Dec 2014
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Skills Training: Parents of School-Aged Children
- ClinicalTrials.gov ID
- NCT02329340
- Acronym / sponsor ID
- SAS_2 / SBIR76R-2
- Conditions
- Injuries
- Keywords
- child safety, injury, prevention, computer, internet
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 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
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 31 Dec 2014 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Am Academy of Pediatrics print materials | Active comparator | Behavioral: Am Academy of Pediatrics print materialsIn-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. |
| Family Safety 1-2-3 | Experimental | Behavioral: Family safety 1-2-3In-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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Am Academy of Pediatrics print materialsAlso: The Injury Prevention Program; tip sheetsPrint materials of injury prevention content. | Behavioural | Am Academy of Pediatrics print materials |
| Family safety 1-2-3Theoretically based school-aged childhood injury prevention videos for families | Behavioural | Family Safety 1-2-3 |
Primary outcome
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.
3 secondary outcomes
Knowledge of injury prevention strategies
Time frame: immediate posttest and 30-day follow-up
Attitudes and beliefs about injury prevention strategies
Time frame: immediate posttest and 30-day follow-up
Self-efficacy for engaging in injury prevention strategies
Time frame: immediate posttest and 30-day follow-up
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 31 Dec 2014.
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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 Am Academy of Pediatrics print materials and Family safety 1-2-3 in people with Injuries, 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 31 Dec 2014. 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?
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). 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 31 Dec 2014.