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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alejandro Interian, PhD, Department of Veterans Affairs, New Jersey
ClinicalTrials.gov Identifier:
NCT01554839
First received: March 5, 2012
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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 Intervention
Post Traumatic Stress Disorder
PTSD
Behavioral: "Family of Heroes"
Behavioral: Baseline and Follow up Surveys

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs, New Jersey:

Primary Outcome Measures:
  • Mental Health Treatment Engagement [ Time Frame: 6 months post enrollment ] [ Designated as safety issue: No ]
    Number of mental health visits attended. Obtained from chart review.


Secondary Outcome Measures:
  • Change in Perceived Criticism Score [ Time Frame: Baseline and 2 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 2 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Study Start Date: October 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01554839

Locations
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
Principal Investigator: Alejandro Interian, PhD Department of Veteran Affairs, New Jersey
  More Information

No publications provided

Responsible Party: Alejandro Interian, PhD, Clinical Psychologist, Department of Veterans Affairs, New Jersey
ClinicalTrials.gov Identifier: NCT01554839     History of Changes
Other Study ID Numbers: MIRB#01165
Study First Received: March 5, 2012
Last Updated: June 18, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014