Evaluating a Website for Parents of Injured Children
Primary Purpose
Acute Post-Traumatic Stress Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
After The Injury website
Control
Sponsored by
About this trial
This is an interventional prevention trial for Acute Post-Traumatic Stress Disorder
Eligibility Criteria
Inclusion Criteria:
- Children age 6 through 17 who sustained an injury within the past 2 months and their parents.
- Have access to the Internet at home (for Stage 3 only)
Exclusion Criteria:
- Parent does not read or understand English
- Child's injury is due to participation in organized sports
- Child's injury is due to suspected abuse or family violence
Sites / Locations
- Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
After The Injury website
Usual care
Arm Description
Treatment as usual
Outcomes
Primary Outcome Measures
Scores on measure of parent knowledge re: traumatic stress and coping assistance.
Secondary Outcome Measures
Full Information
NCT ID
NCT00974467
First Posted
September 9, 2009
Last Updated
March 11, 2015
Sponsor
Children's Hospital of Philadelphia
1. Study Identification
Unique Protocol Identification Number
NCT00974467
Brief Title
Evaluating a Website for Parents of Injured Children
Official Title
Evaluating a Website for Parents of Injured Children
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the current protocol is to evaluate the ability of the AfterTheInjury website to increase parent knowledge and skills.
Detailed Description
The purpose of the current protocol is to evaluate the ability of the AfterTheInjury website to increase parent knowledge and skills. Primary objective is to compare website condition vs control with regard to (a) immediate parent learning outcomes and (b) coping assistance provided by parents as reported at 6 wks. Secondary objective is to compare conditions as above with regard to child and parent PTS symptoms at 6 wks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Post-Traumatic Stress Disorder
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
After The Injury website
Arm Type
Experimental
Arm Title
Usual care
Arm Type
Other
Arm Description
Treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
After The Injury website
Intervention Description
Parents participate in a web-based prevention intervention, which provides education and tips specific to coping with a child's injury.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Usual hospital care provided.
Primary Outcome Measure Information:
Title
Scores on measure of parent knowledge re: traumatic stress and coping assistance.
Time Frame
6 wks post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children age 6 through 17 who sustained an injury within the past 2 months and their parents.
Have access to the Internet at home (for Stage 3 only)
Exclusion Criteria:
Parent does not read or understand English
Child's injury is due to participation in organized sports
Child's injury is due to suspected abuse or family violence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Kassam-Adams, Ph.D.
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluating a Website for Parents of Injured Children
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