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

This study has been terminated.
(Loss of funding)
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier:
NCT01062022
First received: February 1, 2010
Last updated: August 16, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention
Stress Disorders
Combat Disorders
Traumatic Stress Disorders
Behavioral: Standard of Care
Behavioral: FOCUS-CI

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: FOCUS-CI: A Preventive Intervention With Children and Families of the Combat Injured

Further study details as provided by Henry M. Jackson Foundation for the Advancement of Military Medicine:

Primary Outcome Measures:
  • parent and child distress (including mental health service usage, symptoms of PTSD and Depression) [ Time Frame: every 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Participant Satisfaction with Intervention [ Time Frame: every 12 months ] [ Designated as safety issue: No ]
  • Clinician Satisfaction with Intervention [ Time Frame: months 12 and 24 at followup ] [ Designated as safety issue: No ]
  • Parent Functioning (including substance use, parental efficacy, parental satisfaction, parenting behavior, social support and posttraumatic growth) [ Time Frame: at 12 and 24 month followups ] [ Designated as safety issue: No ]
  • Child Functioning (School Functioning, and Coping) Family Functioning (Communication, Problem Solving, Roles, and Relationships) [ Time Frame: at 12 and 24 month followup ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: January 2011
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: FOCUS-CI, Families OverComing Under Stress-Combat Injury

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.
  Eligibility

Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062022

Locations
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5001
United States, Texas
Brooke Army Medical Center
San Antonio, Texas, United States, 78234
United States, Washington
Madigan Army Medical Center
Seattle, Washington, United States, 98431
Sponsors and Collaborators
Henry M. Jackson Foundation for the Advancement of Military Medicine
U.S. Army Medical Research and Materiel 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)
  More Information

Additional Information:
USUHS  This link exits the ClinicalTrials.gov site

Responsible Party: Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier: NCT01062022     History of Changes
Other Study ID Numbers: G188NI  W81XWH-08-2-0650 
Study First Received: February 1, 2010
Last Updated: August 16, 2016
Health Authority: United States: Institutional Review Board
United States: Federal Government
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: study ended - no data

Keywords provided by Henry M. Jackson Foundation for the Advancement of Military Medicine:
intervention
combat wounded
family
Focus-CI

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Combat Disorders
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on December 02, 2016