NCT02934165

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2014

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

October 14, 2016

Completed
Last Updated

October 14, 2016

Status Verified

October 1, 2016

Enrollment Period

1 year

First QC Date

December 30, 2014

Last Update Submit

October 12, 2016

Conditions

Behavior

Keywords

child safetyinjurycomputerpreventioninternet

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (9)

  • Change in knowledge of injury prevention strategies

    30 days and 60 days

  • Change in attitudes and beliefs about injury prevention strategies

    30 days and 60 days

  • Change in self-efficacy for engaging in injury prevention strategies

    30 days and 60 days

  • Change in car safety knowledge of injury prevention

    30 days and 60 days

  • Change in car safety attitudes & beliefs of injury prevention

    30 days and 60 days

  • +4 more secondary outcomes

Study Arms (2)

Family Safety 123

EXPERIMENTAL

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

AAP TIPP sheets

ACTIVE COMPARATOR

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

Interventions

Family Safety 123BEHAVIORAL

Theoretically-based injury prevention videos for families

Also known as: Family Safety 123 for Parents of Children 2-5
Family Safety 123
AAP TIPP sheetsBEHAVIORAL

American Academy of Pediatrics The Injury Prevent Program materials converted to web-based materials.

AAP TIPP sheets

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Center for Applied Science

Eugene, Oregon, 97401, United States

Location

MeSH Terms

Conditions

BehaviorWounds and Injuries

Study Officials

  • Lynne H Grilley Swartz, MPH, CHES

    Oregon Center for Applied Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2014

First Posted

October 14, 2016

Study Start

September 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

October 14, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)