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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02329340
Other study ID # SBIR76R-2
Secondary ID R44HD048005
Status Completed
Phase Phase 2
First received December 29, 2014
Last updated December 29, 2014
Start date September 2009
Est. completion date August 2010

Study information

Verified date December 2014
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

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 175
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

Behavioral:
Am Academy of Pediatrics print materials
Print materials of injury prevention content.
Family safety 1-2-3
Theoretically based school-aged childhood injury prevention videos for families

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: 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. Immediate posttest and 30-day follow-up No
Secondary 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. immediate posttest and 30-day follow-up No
Secondary 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. immediate posttest and 30-day follow-up No
Secondary 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. immediate posttest and 30-day follow-up No
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