Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02934165
Other study ID # SBIR72RR-2
Secondary ID R44HD047068
Status Completed
Phase N/A
First received December 30, 2014
Last updated October 12, 2016
Start date September 2009
Est. completion date September 2010

Study information

Verified date October 2016
Source Oregon Center for Applied Science, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 151
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Family Safety 123
Theoretically-based injury prevention videos for families
AAP TIPP sheets
American Academy of Pediatrics The Injury Prevent Program materials converted to web-based materials.

Locations

Country Name City State
United States Oregon Center for Applied Science Eugene Oregon

Sponsors (2)

Lead Sponsor Collaborator
Oregon Center for Applied Science, Inc. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 30 days and 60 days No
Secondary 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. 30 days and 60 days No
Secondary 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. 30 days and 60 days No
Secondary 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. 30 days and 60 days No
Secondary 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. 30 days and 60 days No
Secondary 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. 30 days and 60 days No
Secondary 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. 30 days and 60 days No
Secondary 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. 30 days and 60 days No
Secondary 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. 30 days and 60 days No
Secondary 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. 30 days and 60 days No
See also
  Status Clinical Trial Phase
Completed NCT04612842 - Engaging Older Adults in Fall Prevention Using Motivational Interviewing (MI) N/A
Active, not recruiting NCT05516264 - Behavioural and Physiological Responses to Dog Visits in Nursing Homes N/A
Completed NCT05152342 - Reducing Stigma Among Individuals With Addiction and Staff in the Criminal Justice System N/A
Enrolling by invitation NCT05092100 - Neural Mechanisms for Reducing Interference During Episodic Memory Formation N/A
Completed NCT03216213 - Evaluating Attitudes Towards Organ Donation in Singapore N/A
Completed NCT04656574 - The Effects of Sımulatıon Used in Vagınal Chıldbırth on Malpractıce Tendency And Perceptıons of Care Behavıors N/A
Enrolling by invitation NCT05319821 - PA Moves Trial - PCP Participants N/A
Not yet recruiting NCT03266666 - Welcome to WellnessRX: Steps Toward a Healthier Life! N/A
Completed NCT03003923 - Promoting Vegetable Intake in Preschool Aged Children N/A
Completed NCT02267265 - Pilot Study of Novel Postpartum Educational Video Intervention N/A
Completed NCT01629069 - A Transplant or Cancer Resilience Intervention N/A
Completed NCT01945645 - Ready to Act - Health Education in People With Hyperglycaemia N/A
Completed NCT00056940 - Prevention of Violent Behavior Among Children N/A
Recruiting NCT03912597 - VR-assisted Curriculum on Depression for Stigma Reduction N/A
Completed NCT04525703 - Pathways for Parents After Incarceration Feasibility Study N/A
Completed NCT06217289 - A Study on Behavior of Healthcare Professionals Who Handle Oral Solid Drug
Completed NCT04078633 - Innovative Hand Washing Interventions for Internally Displaced Populations in Ethiopia N/A
Completed NCT03687658 - Applying Novel Technologies and Methods to Self-Regulation: Behavior Change Tools for Smoking and Binge Eating N/A
Completed NCT04826276 - Effects of Smoking State on Decision Making N/A
Not yet recruiting NCT04924452 - Er:YAG Laser Therapy in Combination With Behaviour Management Technique in Reducing Anxiety Among Paediatric Patients N/A