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

NCT ID: NCT01554839

Last Updated: 2015-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post Traumatic Stress Disorder PTSD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment Group

Treatment group participates in 1 hour online educational tool in addition to baseline and follow up surveys

Group Type EXPERIMENTAL

"Family of Heroes"

Intervention Type BEHAVIORAL

One hour online educational tool

Baseline and Follow up Surveys

Intervention Type BEHAVIORAL

Baseline and follow up questionaires completed online

Non Treatment Group

Non Treatment group participates in baseline and follow up surveys

Group Type PLACEBO_COMPARATOR

Baseline and Follow up Surveys

Intervention Type BEHAVIORAL

Baseline and follow up questionaires completed online

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

"Family of Heroes"

One hour online educational tool

Intervention Type BEHAVIORAL

Baseline and Follow up Surveys

Baseline and follow up questionaires completed online

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Department of Veterans Affairs, New Jersey

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Alejandro Interian, PhD

Clinical Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alejandro Interian, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Veteran Affairs, New Jersey

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

VANJHCS (Veterans Administration New Jersey Health Care Services)

Lyons, New Jersey, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 27898154 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MIRB#01165

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Supported Education Pilot
NCT01073657 COMPLETED EARLY_PHASE1