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

Primary Purpose

Stress Disorders, Combat Disorders, Traumatic Stress Disorders

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of Care
FOCUS-CI
Sponsored by
Henry M. Jackson Foundation for the Advancement of Military Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress Disorders focused on measuring intervention, combat wounded, family, Focus-CI

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Walter Reed Army Medical Center
  • Brooke Army Medical Center
  • Madigan Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control - Standard of Care

FOCUS-CI

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

parent and child distress (including mental health service usage, symptoms of PTSD and Depression)

Secondary Outcome Measures

Participant Satisfaction with Intervention
Clinician Satisfaction with Intervention
Parent Functioning (including substance use, parental efficacy, parental satisfaction, parenting behavior, social support and posttraumatic growth)
Child Functioning (School Functioning, and Coping) Family Functioning (Communication, Problem Solving, Roles, and Relationships)

Full Information

First Posted
February 1, 2010
Last Updated
August 16, 2016
Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators
U.S. Army Medical Research and Development Command
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1. Study Identification

Unique Protocol Identification Number
NCT01062022
Brief Title
FOCUS-CI: A Preventive Intervention With Children and Families of the Combat Injured
Acronym
FOCUS-CI
Official Title
FOCUS-CI: A Preventive Intervention With Children and Families of the Combat Injured
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
Loss of funding
Study Start Date
January 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators
U.S. Army Medical Research and Development Command

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Combat Disorders, Traumatic Stress Disorders
Keywords
intervention, combat wounded, family, Focus-CI

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control - Standard of Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
FOCUS-CI
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care
Other Intervention Name(s)
comparison group, standard of care
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
FOCUS-CI
Other Intervention Name(s)
FOCUS-CI, Families OverComing Under Stress-Combat Injury
Intervention Description
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
Primary Outcome Measure Information:
Title
parent and child distress (including mental health service usage, symptoms of PTSD and Depression)
Time Frame
every 12 months
Secondary Outcome Measure Information:
Title
Participant Satisfaction with Intervention
Time Frame
every 12 months
Title
Clinician Satisfaction with Intervention
Time Frame
months 12 and 24 at followup
Title
Parent Functioning (including substance use, parental efficacy, parental satisfaction, parenting behavior, social support and posttraumatic growth)
Time Frame
at 12 and 24 month followups
Title
Child Functioning (School Functioning, and Coping) Family Functioning (Communication, Problem Solving, Roles, and Relationships)
Time Frame
at 12 and 24 month followup

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Cozza, MD
Organizational Affiliation
Uniformed Services University of the Health Sciences (USUHS)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Ursano, MD
Organizational Affiliation
Uniformed Services University of the Health Sciences (USUHS)
Official's Role
Study Chair
Facility Information:
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307-5001
Country
United States
Facility Name
Brooke Army Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Madigan Army Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98431
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
study ended - no data
Links:
URL
http://www.usuhs.edu
Description
USUHS
URL
http://www.hjf.org
Description
Henry M. Jackson Foundation for the Advancement of Military Medicine

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

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