Clinical trial NCT01062022: FOCUS-CI: A Preventive Intervention With Children and Families of the Combat Injured
Official title: FOCUS-CI: A Preventive Intervention With Children and Families of the Combat Injured
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stress Disorders
Combat Disorders
Traumatic Stress Disorders
Keywords: intervention
combat wounded
family
Focus-CI
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2010-02-04
Enrollment: 23
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: parent and child distress (including mental health service usage, symptoms of PTSD and Depression)
timeFrame: every 12 months
Secondary outcomes:
measure: Participant Satisfaction with Intervention
timeFrame: every 12 months
measure: Clinician Satisfaction with Intervention
timeFrame: months 12 and 24 at followup
measure: Parent Functioning (including substance use, parental efficacy, parental satisfaction, parenting behavior, social support and posttraumatic growth)
timeFrame: at 12 and 24 month followups
measure: Child Functioning (School Functioning, and Coping) Family Functioning (Communication, Problem Solving, Roles, and Relationships)
timeFrame: at 12 and 24 month followup
Other outcomes:
Locations:
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Seattle
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: Uniformed Services University of the Health Sciences (USUHS)
name: Stephen Cozza, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Uniformed Services University of the Health Sciences (USUHS)
name: Robert Ursano, MD
role: STUDY_CHAIR
References: