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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02934633
Other study ID # SBIR 63-2
Secondary ID R44HD044281
Status Completed
Phase Phase 2
First received May 31, 2013
Last updated October 13, 2016
Start date August 2006
Est. completion date August 2008

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

This project completed an intervention designed to teach parents of children aged 0-2 years of age how to prevent injuries to their child. The intervention consisted of a two DVD package with information on creating a safe home environment and correctly choosing and installing an appropriate car safety seat. The study hypothesis was that parents who used the intervention would score significantly higher on measures of knowledge, motivation, intention and self-efficacy in implementing injury prevention strategies.


Recruitment information / eligibility

Status Completed
Enrollment 414
Est. completion date August 2008
Est. primary completion date August 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 13 Years to 65 Years
Eligibility Inclusion Criteria:

- 18 years or older

- Parent whose oldest child is 0-24 months old

- Speak and read English

- Have internet access (online study only)

Exclusion Criteria:

- Parents who do not have legal or physical custody

- Subjects live in a household in which a family member had an overnight stay in the hospital as a result of an injury in the last 2 years

Study Design

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


Related Conditions & MeSH terms


Intervention

Behavioral:
Keeping Baby Safe 2-DVD package
Keeping Baby Safe is a 2-DVD package that teaches childhood injury prevention skills to parents of children from birth to 24 months of age. One DVD addresses automobile passenger safety and focuses on the correct choice and proper installation of child safety seat for the age of the parent's child. The second DVD covers a core set of home safety skills: (a) preventing falls, (b) preventing fires and burns, (c) preventing poisoning, (d) firearm safety, (e) preventing drowning, (f) preventing suffocation and choking, (e) play equipment safety, and (f) animal safety. Content in the home safety DVD is based on information the American Academy of Pediatrics (AAP) recommends that physicians provide to parents during well-baby visits.
The Injury Prevention Program (TIPP) sheets
American Academy of Pediatrics The Injury Prevention Program (TIPP) sheets. Paper-based information sheets parents would typically receive from their pediatrician or general practitioner at well-baby visits.

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 Change in parent motivation to implement injury prevention strategies 7 day and 30 day post intervention No
Primary Change in parent knowledge of injury prevention practices 7 and 30 day post intervention No
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