Stress DisordersFOCUS-CINCT01062022
FOCUS-CI: A Preventive Intervention With Children and Families of the Combat Injured
A study testing FOCUS-CI in people with Stress Disorders and Combat Disorders, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 3 sites in United States.
Trial summary
The purpose of this study is to implement a unique evidence-based intervention program to help military families deal with the critical issue of combat injury and its impact on current and future family health and functioning. The study is a randomized study. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Stress Disorders, Combat Disorders, Traumatic Stress Disorders
- What is being tested?
- FOCUS-CI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2011to Nov 2014
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- For a family to be eligible for the study, the injured service member must:
- have sustained a combat injury that was severe enough to require a minimum of two weeks inpatient hospitalization immediately after the injury;
- currently be participating in outpatient rehabilitation for the same combat injury;
- must be within 6 months of discharge from inpatient hospitalization at the start of the intervention;
- families must have at least one child between the ages of 5 and 18 and be fluent in English. English fluency will be determined by asking, "Is English spoken in your home?"
- pregnant women are eligible to participate.
Who cannot join
- families in which the service member did not sustain a qualifying injury or has been discharged from inpatient care for more than six months will not be eligible to participate
- families in which a member is actively psychotic
- families in which a service member's primary relationship is with a "significant other" who is not eligible for military medical care
- due to the limited ability of young children to comprehend the intervention activities, children under the age of 5 years will not be invited to participate in the intervention.
- no one will be excluded based on race, ethnicity, gender, pregnancy, medical status, or cognitive functioning.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Brooke Army Medical Center
San Antonio, Texas, 78234
Madigan Army Medical Center
Seattle, Washington, 98431
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5001
About this study
The purpose of this study is to implement a unique evidence-based intervention program to help military families deal with the critical issue of combat injury and its impact on current and future family health and functioning. The study is a randomized study. The study will compare the effects of the newly designed FOCUS-CI (Families OverComing Under Stress - Combat Injury) with the existing standard of care (SoC) at three military medical rehabilitation sites (Walter Reed Amry Medical Center, Brooke Army Medical Center and Madigan Army Medical Center) on key aspects of family health and functioning.
Read the detailed description
Injured service members who have at least one child between the ages of 5 and 18 years who have sustained a combat injury severe enough to require at least two weeks of inpatient hospitalization and who are within 6 months of discharge from inpatient hospitalization and currently receiving outpatient care will be recruited into this study.
- Being tested
- Standard of Care, FOCUS-CI
- Keywords
- intervention, combat wounded, family, Focus-CI
- Medical subject headings
- Stress Disorders, Traumatic, Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareBehavioural
Also called comparison group, standard of care
Families randomized to this arm will receive the standard of care. They will be compared to the families in the FOCUS-CI arm of the study.
FOCUS-CIBehavioural
Also called FOCUS-CI, Families OverComing Under Stress-Combat Injury
Families randomized to this arm of the study will be part of a family skill-building/resiliency training program designed to provide information and skills training
| Study group | Role | What they receive |
|---|---|---|
| Control - Standard of Care | Active comparator | Participation in the study will involve your child completing a questionnaire about (a) your family's background, descriptive information about people in your family, and previous major life events, (b) his/her current functioning, (c) his/her feelings before, during, and after the combat injury, and (d) his/her current social relationships and adjustment. Your child will be asked to complete the questionnaire during the baseline assessment, and at 6 months, 12 months, and 24 months after the original assessment. Receives: Behavioral: Standard of Care |
| FOCUS-CI | Active comparator | Those participants in the FOCUS-CI intervention will be part of a family skill-building/resiliency training program designed to provide information and skills training in a variety of forms, including clinician-led sessions, handouts, on-line training modules, and individual family care management. Study participation will also involve completing a questionnaire about (a) your family's background, descriptive information about people in your family, and previous major life events, (b) his/her current functioning, (c) his/her feelings before, during, and after the combat injury, and (d) his/her current social relationships and adjustment. Questionnaires will be completed during the baseline assessment, and at 6 months, 12 months, and 24 months after the baseline assessment. Receives: Behavioral: FOCUS-CI |
What is being measured
The primary outcome is the main question the study is designed to answer.
parent and child distress (including mental health service usage, symptoms of PTSD and Depression)
Measured: every 12 months
Secondary outcomes (4)
Participant Satisfaction with Intervention
Measured: every 12 months
Clinician Satisfaction with Intervention
Measured: months 12 and 24 at followup
Parent Functioning (including substance use, parental efficacy, parental satisfaction, parenting behavior, social support and posttraumatic growth)
Measured: at 12 and 24 month followups
Child Functioning (School Functioning, and Coping) Family Functioning (Communication, Problem Solving, Roles, and Relationships)
Measured: at 12 and 24 month followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startJan 2011
- Primary completionNov 2014
- Study completionNov 2014
Why it stopped: Loss of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress DisordersStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
- Investigators
- Stephen Cozza, MD, Principal investigator, Uniformed Services University of the Health Sciences (USUHS)Robert Ursano, MD, Study chair, Uniformed Services University of the Health Sciences (USUHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062022
- Sponsor's protocol ID
- G188NI
- Other IDs
- W81XWH-08-2-0650
- Acronym
- FOCUS-CI
- Status last verified
- Aug 2016
- First submitted
- 1 Feb 2010
- Last updated
- 18 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: study ended - no data
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FOCUS-CI: A Preventive Intervention With Children and Families of the Combat Injured
- ClinicalTrials.gov ID
- NCT01062022
- Acronym / sponsor ID
- FOCUS-CI / G188NI
- Keywords
- intervention, combat wounded, family, Focus-CI
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Loss of funding
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- Jan 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 4 Feb 2010 (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 implement a unique evidence-based intervention program to help military families deal with the critical issue of combat injury and its impact on current and future family health and functioning. The study is a randomized study. The study will compare the effects of the newly designed FOCUS-CI (Families OverComing Under Stress - Combat Injury) with the existing standard of care (SoC) at three military medical rehabilitation sites (Walter Reed Amry Medical Center, Brooke Army Medical Center and Madigan Army Medical Center) on key aspects of family health and functioning.
Detailed description
Injured service members who have at least one child between the ages of 5 and 18 years who have sustained a combat injury severe enough to require at least two weeks of inpatient hospitalization and who are within 6 months of discharge from inpatient hospitalization and currently receiving outpatient care will be recruited into this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control - Standard of Care | Active comparator | Behavioral: Standard of CareParticipation in the study will involve your child completing a questionnaire about (a) your family's background, descriptive information about people in your family, and previous major life events, (b) his/her current functioning, (c) his/her feelings before, during, and after the combat injury, and (d) his/her current social relationships and adjustment. Your child will be asked to complete the questionnaire during the baseline assessment, and at 6 months, 12 months, and 24 months after the original assessment. |
| FOCUS-CI | Active comparator | Behavioral: FOCUS-CIThose participants in the FOCUS-CI intervention will be part of a family skill-building/resiliency training program designed to provide information and skills training in a variety of forms, including clinician-led sessions, handouts, on-line training modules, and individual family care management. Study participation will also involve completing a questionnaire about (a) your family's background, descriptive information about people in your family, and previous major life events, (b) his/her current functioning, (c) his/her feelings before, during, and after the combat injury, and (d) his/her current social relationships and adjustment. Questionnaires will be completed during the baseline assessment, and at 6 months, 12 months, and 24 months after the baseline assessment. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- have sustained a combat injury that was severe enough to require a minimum of two weeks inpatient hospitalization immediately after the injury;
- currently be participating in outpatient rehabilitation for the same combat injury;
- must be within 6 months of discharge from inpatient hospitalization at the start of the intervention;
- families must have at least one child between the ages of 5 and 18 and be fluent in English. English fluency will be determined by asking, "Is English spoken in your home?"
- pregnant women are eligible to participate.
Key exclusion criteria (5 listed)
- families in which the service member did not sustain a qualifying injury or has been discharged from inpatient care for more than six months will not be eligible to participate
- families in which a member is actively psychotic
- families in which a service member's primary relationship is with a "significant other" who is not eligible for military medical care
- due to the limited ability of young children to comprehend the intervention activities, children under the age of 5 years will not be invited to participate in the intervention.
- no one will be excluded based on race, ethnicity, gender, pregnancy, medical status, or cognitive functioning.
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 |
|---|---|---|
| Standard of CareAlso: comparison group, standard of careFamilies randomized to this arm will receive the standard of care. They will be compared to the families in the FOCUS-CI arm of the study. | Behavioural | Control - Standard of Care |
| FOCUS-CIAlso: FOCUS-CI, Families OverComing Under Stress-Combat InjuryFamilies randomized to this arm of the study will be part of a family skill-building/resiliency training program designed to provide information and skills training | Behavioural | FOCUS-CI |
Primary outcome
parent and child distress (including mental health service usage, symptoms of PTSD and Depression)
Time frame: every 12 months
4 secondary outcomes
Participant Satisfaction with Intervention
Time frame: every 12 months
Clinician Satisfaction with Intervention
Time frame: months 12 and 24 at followup
Parent Functioning (including substance use, parental efficacy, parental satisfaction, parenting behavior, social support and posttraumatic growth)
Time frame: at 12 and 24 month followups
Child Functioning (School Functioning, and Coping) Family Functioning (Communication, Problem Solving, Roles, and Relationships)
Time frame: at 12 and 24 month followup
Results and safety
The study was stopped early (reason given: Loss of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
- USUHSLink provided by the sponsor.
- Henry M. Jackson Foundation for the Advancement of Military MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. study ended - no data
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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.
Stephen Cozza, MD principal investigator
Uniformed Services University of the Health Sciences (USUHS)
Robert Ursano, MD study chair
Uniformed Services University of the Health Sciences (USUHS)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FOCUS-CI in people with Stress Disorders and Combat Disorders, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 3 sites 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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 18 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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 was stopped early (reason given: Loss of funding). Results are not available in the source record.
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?
parent and child distress (including mental health service usage, symptoms of PTSD and Depression) (time frame: every 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2016.