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

Not Applicable

Terminated

• Conditions: Stress Disorders; Combat Disorders; Traumatic Stress Disorders
• Interventions: Behavioral: Standard of Care; Behavioral: FOCUS-CI

• Registration Number: NCT01062022
• Lead Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

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.

Study Timeline

• Study First Submitted: 2010-02-01
• Study First Submitted QC: 2010-02-02
• Study First Posted: 2010-02-04
• Study Start: 2011-01
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-16
• Last Update Posted: 2016-08-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control - Standard of Care	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.
FOCUS-CI	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Parent Functioning (including substance use, parental efficacy, parental satisfaction, parenting behavior, social support and posttraumatic growth)	at 12 and 24 month followups
Participant Satisfaction with Intervention	every 12 months
Clinician Satisfaction with Intervention	months 12 and 24 at followup
Child Functioning (School Functioning, and Coping) Family Functioning (Communication, Problem Solving, Roles, and Relationships)	at 12 and 24 month followup

Trial Locations

Locations (3)

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, United States