Back to resultsThe Family of Heroes: an Evaluation of an Online Educational Tool
Primary Purpose
Post Traumatic Stress Disorder, PTSD
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
"Family of Heroes"
Baseline and Follow up Surveys
Sponsored by
About this trial
This is an interventional treatment trial for Post Traumatic Stress Disorder
Eligibility Criteria
Inclusion Criteria:
- Male or female Operation Iraqi Freedom/ Operation Enduring Freedom (OIF/OEF) veteran
- Positive for PTSD, based on PTSD Checklist (PCL) score greater than or equal to 50
- Availability of a family member who is both willing to participate in the study AND has contact with the veteran 3 or more times per week
- Ability to access a computer with internet access to take educational training and surveys
Exclusion Criteria:
- Not and OIF/OEF veteran
- Negative for PTSD, based on PCL score less than 50
- Unavailability of a family member who is both willing to participate in the study or has contact with the veteran 3 or more times per week
- Inability to access a computer with internet access to take the educational training and surveys
Sites / Locations
- VANJHCS (Veterans Administration New Jersey Health Care Services)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment Group
Non Treatment Group
Arm Description
Treatment group participates in 1 hour online educational tool in addition to baseline and follow up surveys
Non Treatment group participates in baseline and follow up surveys
Outcomes
Primary Outcome Measures
Mental Health Treatment Engagement
Number of mental health visits attended. Obtained from chart review.
Secondary Outcome Measures
Change in Perceived Criticism Score
4 questions answered on a scale of 1 to 10; 1 being not at all critical and 10 being very critical.
Change in Family Empowerment Scale Score
12 questions answered on a scale of 1 through 5. 1 = not true at all, 2 = mostly not true, 3 = somewhat true, 4 = mostly true, and 5 = very true.
Full Information
NCT ID
NCT01554839
First Posted
March 5, 2012
Last Updated
February 9, 2015
Sponsor
Department of Veterans Affairs, New Jersey
1. Study Identification
Unique Protocol Identification Number
NCT01554839
Brief Title
The Family of Heroes: an Evaluation of an Online Educational Tool
Official Title
The Family of Heroes Program for Veterans and Their Families: An Evaluation of an Online Educational Tool for Helping Veterans.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Department of Veterans Affairs, New Jersey
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effectiveness of a unique web based educational tool called "Family of Heroes," which is designed to educate families about Post Traumatic Stress Disorder (PTSD) and provide them with practical tools for interacting with affected veteran family members. The study includes veterans and a family member of their choosing. Participants are randomly assigned to a group which takes the online training or a group that does not take the training. Both groups complete a baseline questionnaire and a follow up questionaire 60 days later. The study will examine the number of Veteran Affairs (VA) mental health visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder, PTSD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
206 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Treatment group participates in 1 hour online educational tool in addition to baseline and follow up surveys
Arm Title
Non Treatment Group
Arm Type
Placebo Comparator
Arm Description
Non Treatment group participates in baseline and follow up surveys
Intervention Type
Behavioral
Intervention Name(s)
"Family of Heroes"
Intervention Description
One hour online educational tool
Intervention Type
Behavioral
Intervention Name(s)
Baseline and Follow up Surveys
Intervention Description
Baseline and follow up questionaires completed online
Primary Outcome Measure Information:
Title
Mental Health Treatment Engagement
Description
Number of mental health visits attended. Obtained from chart review.
Time Frame
6 months post enrollment
Secondary Outcome Measure Information:
Title
Change in Perceived Criticism Score
Description
4 questions answered on a scale of 1 to 10; 1 being not at all critical and 10 being very critical.
Time Frame
Baseline and 2 months
Title
Change in Family Empowerment Scale Score
Description
12 questions answered on a scale of 1 through 5. 1 = not true at all, 2 = mostly not true, 3 = somewhat true, 4 = mostly true, and 5 = very true.
Time Frame
Baseline and 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female Operation Iraqi Freedom/ Operation Enduring Freedom (OIF/OEF) veteran
Positive for PTSD, based on PTSD Checklist (PCL) score greater than or equal to 50
Availability of a family member who is both willing to participate in the study AND has contact with the veteran 3 or more times per week
Ability to access a computer with internet access to take educational training and surveys
Exclusion Criteria:
Not and OIF/OEF veteran
Negative for PTSD, based on PCL score less than 50
Unavailability of a family member who is both willing to participate in the study or has contact with the veteran 3 or more times per week
Inability to access a computer with internet access to take the educational training and surveys
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alejandro Interian, PhD
Organizational Affiliation
Department of Veteran Affairs, New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
VANJHCS (Veterans Administration New Jersey Health Care Services)
City
Lyons
State/Province
New Jersey
ZIP/Postal Code
07939
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27898154
Citation
Interian A, Kline A, Perlick D, Dixon L, Feder A, Weiner MD, Goldstein MF, Hennessy K, St Hill L, Losonczy M. Randomized controlled trial of a brief Internet-based intervention for families of Veterans with posttraumatic stress disorder. J Rehabil Res Dev. 2016;53(5):629-640. doi: 10.1682/JRRD.2014.10.0257.
Results Reference
derived
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The Family of Heroes: an Evaluation of an Online Educational Tool
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