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

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.

Study Overview

• Status: Terminated
• Conditions: Combat Disorders; Stress Disorders; Traumatic Stress Disorders
• Intervention / Treatment: Behavioral: Standard of Care; Behavioral: FOCUS-CI

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20307-5001
      • Walter Reed Army Medical Center
  • Texas
    • San Antonio, Texas, United States, 78234
      • Brooke Army Medical Center
  • Washington
    • Seattle, Washington, United States, 98431
      • Madigan Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control - Standard of Care; 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; 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.; Other Names: comparison group, standard of care
Active Comparator: FOCUS-CI; 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; 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; Other Names: FOCUS-CI, Families OverComing Under Stress-Combat Injury

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Collaborators: U.S. Army Medical Research and Development Command
• Investigators: Principal Investigator: Stephen Cozza, MD, Uniformed Services University of the Health Sciences (USUHS); Study Chair: Robert Ursano, MD, Uniformed Services University of the Health Sciences (USUHS)

Publications and helpful links

Helpful Links

• Henry M. Jackson Foundation for the Advancement of Military Medicine
• USUHS
• Walter Reed Army Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: February 1, 2010
• First Submitted That Met QC Criteria: February 2, 2010
• First Posted (Estimate): February 4, 2010

Study Record Updates

• Last Update Posted (Estimate): August 18, 2016
• Last Update Submitted That Met QC Criteria: August 16, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: family; intervention; combat wounded; Focus-CI
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Trauma and Stressor Related Disorders; Disease; Stress Disorders, Traumatic; Combat Disorders
• Other Study ID Numbers: G188NI; W81XWH-08-2-0650 (Other Grant/Funding Number: CDMRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: study ended - no data