NCT02329340

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
175

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_2

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
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
Last Updated

December 31, 2014

Status Verified

December 1, 2014

Enrollment Period

11 months

First QC Date

December 29, 2014

Last Update Submit

December 29, 2014

Conditions

Keywords

child safetyinjurypreventioncomputerinternet

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Knowledge of injury prevention strategies

    immediate posttest and 30-day follow-up

  • Attitudes and beliefs about injury prevention strategies

    immediate posttest and 30-day follow-up

  • Self-efficacy for engaging in injury prevention strategies

    immediate posttest and 30-day follow-up

Study Arms (2)

Am Academy of Pediatrics print materials

ACTIVE COMPARATOR

In-person session to read online version of American Academy of Pediatrics The Injury Prevention Program (TIPP sheets) childhood injury prevention print materials, followed by access to the TIPP sheets for 30 days.

Behavioral: Am Academy of Pediatrics print materials

Family Safety 1-2-3

EXPERIMENTAL

In-person session to view video and text-based interactive web site on injury prevention information and strategies, followed by 8 emails delivered over a 30-day period inviting participant to view additional child safety videos.

Behavioral: Family safety 1-2-3

Interventions

Print materials of injury prevention content.

Also known as: The Injury Prevention Program; tip sheets
Am Academy of Pediatrics print materials

Theoretically based school-aged childhood injury prevention videos for families

Family Safety 1-2-3

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

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

Wounds and Injuries

Study Officials

  • Lynne H Grilley Swartz, MPH, CHES

    Oregon Center for Applied Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

December 29, 2014

First Posted

December 31, 2014

Study Start

September 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

December 31, 2014

Record last verified: 2014-12

Locations