FOCUS-CI: A Preventive Intervention With Children and Families of the Combat Injured

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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FOCUS-CI: A Preventive Intervention With Children and Families of the Combat Injured

Conditions
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Stress Disorders, Combat Disorders, Traumatic Stress Disorders

Intervention / Treatment
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* Behavioral: Standard of Care
* Behavioral: FOCUS-CI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control - Standard of Care<br>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. | Behavioral: Standard of Care<br>* 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.<br>* Other names: comparison group, standard of care;|
| Active Comparator: FOCUS-CI<br>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. | Behavioral: FOCUS-CI<br>* 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<br>* Other names: FOCUS-CI, Families OverComing Under Stress-Combat Injury;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| parent and child distress (including mental health service usage, symptoms of PTSD and Depression) |  | every 12 months | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intervention, combat wounded, family, Focus-CI