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

Combat Disorders Clinical Trial

— FOCUS-CI  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01062022
• Other study ID #: G188NI
• Secondary ID: W81XWH-08-2-0650
• Status: Terminated
• Phase: N/A
• First received: February 1, 2010
• Last updated: August 16, 2016
• Start date: January 2011
• Est. completion date: November 2014

Study information

• Verified date: August 2016
• Source: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Combat Disorders
• Disease
• Stress Disorders
• Stress Disorders, Traumatic
• Traumatic Stress Disorders

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	San Antonio	Texas
United States	Madigan Army Medical Center	Seattle	Washington
United States	Walter Reed Army Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Henry M. Jackson Foundation for the Advancement of Military Medicine	U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	parent and child distress (including mental health service usage, symptoms of PTSD and Depression)		every 12 months	No
Secondary	Participant Satisfaction with Intervention		every 12 months	No
Secondary	Clinician Satisfaction with Intervention		months 12 and 24 at followup	No
Secondary	Parent Functioning (including substance use, parental efficacy, parental satisfaction, parenting behavior, social support and posttraumatic growth)		at 12 and 24 month followups	No
Secondary	Child Functioning (School Functioning, and Coping) Family Functioning (Communication, Problem Solving, Roles, and Relationships)		at 12 and 24 month followup	No

External Links

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