The Family of Heroes: an Evaluation of an Online Educational Tool

PTSD Clinical Trial

Official title:

The Family of Heroes Program for Veterans and Their Families: An Evaluation of an Online Educational Tool for Helping Veterans.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01554839
• Other study ID #: MIRB#01165
• Status: Completed
• Phase: N/A
• First received: March 5, 2012
• Last updated: February 9, 2015
• Start date: October 2011
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Department of Veterans Affairs, New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• "Family of Heroes"
One hour online educational tool
• Baseline and Follow up Surveys
Baseline and follow up questionaires completed online

Locations

Country	Name	City	State
United States	VANJHCS (Veterans Administration New Jersey Health Care Services)	Lyons	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Department of Veterans Affairs, New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mental Health Treatment Engagement	Number of mental health visits attended. Obtained from chart review.	6 months post enrollment	No
Secondary	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.	Baseline and 2 months	No
Secondary	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.	Baseline and 2 months	No