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

NCT ID: NCT01062022

Last Updated: 2016-08-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2014-11-30

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.

Conditions

Stress Disorders; Combat Disorders; Traumatic Stress Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

FOCUS-CI

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: BEHAVIORAL

Other Intervention Names

comparison group, standard of care; FOCUS-CI, Families OverComing Under Stress-Combat Injury

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.

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

U.S. Army Medical Research and Development Command

FED

Sponsor Role: collaborator

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Cozza, MD

Role: PRINCIPAL_INVESTIGATOR

Uniformed Services University of the Health Sciences (USUHS)

Robert Ursano, MD

Role: STUDY_CHAIR

Uniformed Services University of the Health Sciences (USUHS)

Locations

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Brooke Army Medical Center

San Antonio, Texas, United States

Madigan Army Medical Center

Seattle, Washington, United States

Countries

United States

Related Links

http://www.usuhs.edu

USUHS

http://www.hjf.org

Henry M. Jackson Foundation for the Advancement of Military Medicine

Other Identifiers

W81XWH-08-2-0650

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

G188NI

Identifier Type: -

Identifier Source: org_study_id