Post Traumatic Stress DisorderNCT01554839
The Family of Heroes: an Evaluation of an Online Educational Tool
A study testing "Family of Heroes" and Baseline and Follow up Surveys in people with Post Traumatic Stress Disorder and PTSD, run by Department of Veterans Affairs, New Jersey at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder, PTSD
- What is being tested?
- "Family of Heroes" and Baseline and Follow up Surveys
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VANJHCS (Veterans Administration New Jersey Health Care Services)
Lyons, New Jersey, 07939
About this study
Official title: 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.
- Conditions
- Post Traumatic Stress Disorder, PTSD
- Being tested
- "Family of Heroes", Baseline and Follow up Surveys
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Family of Heroes"Behavioural
One hour online educational tool
Baseline and Follow up SurveysBehavioural
Baseline and follow up questionaires completed online
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Treatment group participates in 1 hour online educational tool in addition to baseline and follow up surveys Receives: Behavioral: "Family of Heroes"; Behavioral: Baseline and Follow up Surveys |
| Non Treatment Group | Placebo comparator | Non Treatment group participates in baseline and follow up surveys Receives: Behavioral: Baseline and Follow up Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Health Treatment Engagement
Number of mental health visits attended. Obtained from chart review.
Measured: 6 months post enrollment
Secondary outcomes (2)
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.
Measured: Baseline and 2 months
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.
Measured: Baseline and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startOct 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Veterans Affairs, New Jersey
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Alejandro Interian, PhD, Department of Veterans Affairs, New Jersey
- Investigators
- Alejandro Interian, PhD, Principal investigator, Department of Veteran Affairs, New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554839
- Sponsor's protocol ID
- MIRB#01165
- Status last verified
- Jun 2013
- First submitted
- 5 Mar 2012
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27898154
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Family of Heroes Program for Veterans and Their Families: An Evaluation of an Online Educational Tool for Helping Veterans.
- ClinicalTrials.gov ID
- NCT01554839
- Acronym / sponsor ID
- MIRB#01165
- Conditions
- Post Traumatic Stress Disorder, PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Department of Veterans Affairs, New JerseyUS federal agency
- Study start
- Oct 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Behavioral: "Family of Heroes", Behavioral: Baseline and Follow up SurveysTreatment group participates in 1 hour online educational tool in addition to baseline and follow up surveys |
| Non Treatment Group | Placebo comparator | Behavioral: Baseline and Follow up SurveysNon Treatment group participates in baseline and follow up surveys |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Family of Heroes"One hour online educational tool | Behavioural | Treatment Group |
| Baseline and Follow up SurveysBaseline and follow up questionaires completed online | Behavioural | Non Treatment Group, Treatment Group |
Primary outcome
Mental Health Treatment Engagement
Time frame: 6 months post enrollment
Number of mental health visits attended. Obtained from chart review.
2 secondary outcomes
Change in Perceived Criticism Score
Time frame: Baseline and 2 months
Change in Family Empowerment Scale Score
Time frame: Baseline and 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
- Derived from this study: PubMed 27898154Interian 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro Interian, PhD principal investigator
Department of Veteran Affairs, New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Family of Heroes" and Baseline and Follow up Surveys in people with Post Traumatic Stress Disorder and PTSD, run by Department of Veterans Affairs, New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental Health Treatment Engagement (time frame: 6 months post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01554839, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2015.