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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
151

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Family Safety 123
Theoretically-based injury prevention videos for families
Other Names:
  • Family Safety 123 for Parents of Children 2-5
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.
Behavioral: AAP TIPP sheets
American Academy of Pediatrics The Injury Prevent Program materials converted to web-based materials.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon Center for Applied Science, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 14, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SBIR72RR-2
  • R44HD047068 (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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