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

February 9, 2015 updated by: Alejandro Interian, PhD, Department of Veterans Affairs, New Jersey

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

206

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Lyons, New Jersey, United States, 07939
        • VANJHCS (Veterans Administration New Jersey Health Care Services)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mental Health Treatment Engagement
Time Frame: 6 months post enrollment
Number of mental health visits attended. Obtained from chart review.
6 months post enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 2 months
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.
Baseline and 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Department of Veterans Affairs, New Jersey

Investigators

  • Principal Investigator: Alejandro Interian, PhD, Department of Veteran Affairs, New Jersey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

March 5, 2012

First Submitted That Met QC Criteria

March 13, 2012

First Posted (Estimate)

March 15, 2012

Study Record Updates

Last Update Posted (Estimate)

February 10, 2015

Last Update Submitted That Met QC Criteria

February 9, 2015

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIRB#01165

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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