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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01554839
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : February 10, 2015
Sponsor:
Information provided by (Responsible Party):
Alejandro Interian, PhD, Department of Veterans Affairs, New Jersey

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.

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder PTSD Behavioral: "Family of Heroes" Behavioral: Baseline and Follow up Surveys Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Family of Heroes Program for Veterans and Their Families: An Evaluation of an Online Educational Tool for Helping Veterans.
Study Start Date : October 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Arm Intervention/treatment
Experimental: Treatment Group
Treatment group participates in 1 hour online educational tool in addition to baseline and follow up surveys
Behavioral: "Family of Heroes"
One hour online educational tool

Behavioral: Baseline and Follow up Surveys
Baseline and follow up questionaires completed online

Placebo Comparator: Non Treatment Group
Non Treatment group participates in baseline and follow up surveys
Behavioral: Baseline and Follow up Surveys
Baseline and follow up questionaires completed online




Primary Outcome Measures :
  1. Mental Health Treatment Engagement [ Time Frame: 6 months post enrollment ]
    Number of mental health visits attended. Obtained from chart review.


Secondary Outcome Measures :
  1. Change in Perceived Criticism Score [ Time Frame: Baseline and 2 months ]
    4 questions answered on a scale of 1 to 10; 1 being not at all critical and 10 being very critical.

  2. Change in Family Empowerment Scale Score [ Time Frame: Baseline and 2 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01554839


Locations
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United States, New Jersey
VANJHCS (Veterans Administration New Jersey Health Care Services)
Lyons, New Jersey, United States, 07939
Sponsors and Collaborators
Department of Veterans Affairs, New Jersey
Investigators
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Principal Investigator: Alejandro Interian, PhD Department of Veteran Affairs, New Jersey

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alejandro Interian, PhD, Clinical Psychologist, Department of Veterans Affairs, New Jersey
ClinicalTrials.gov Identifier: NCT01554839    
Other Study ID Numbers: MIRB#01165
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: June 2013
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders