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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-08-2-0650 | Other Grant/Funding Number | CDMRP |
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Loss of funding
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| Name | Class |
|---|---|
| U.S. Army Medical Research and Development Command | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care | Behavioral | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| parent and child distress (including mental health service usage, symptoms of PTSD and Depression) | every 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Satisfaction with Intervention | every 12 months | |
| Clinician Satisfaction with Intervention | months 12 and 24 at followup | |
| Parent Functioning (including substance use, parental efficacy, parental satisfaction, parenting behavior, social support and posttraumatic growth) |
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Inclusion Criteria:
For a family to be eligible for the study, the injured service member must:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Cozza, MD | Uniformed Services University of the Health Sciences (USUHS) | Principal Investigator |
| Robert Ursano, MD | Uniformed Services University of the Health Sciences (USUHS) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307-5001 | United States | ||
| Brooke Army Medical Center |
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| Label | URL |
|---|---|
| USUHS | View source |
| Henry M. Jackson Foundation for the Advancement of Military Medicine | View source |
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study ended - no data
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| FOCUS-CI | Behavioral | 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 |
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| at 12 and 24 month followups |
| Child Functioning (School Functioning, and Coping) Family Functioning (Communication, Problem Solving, Roles, and Relationships) | at 12 and 24 month followup |
| San Antonio |
| Texas |
| 78234 |
| United States |
| Madigan Army Medical Center | Seattle | Washington | 98431 | United States |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D003130 | Combat Disorders |
| ID | Term |
|---|---|
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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