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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01062022
Acronym
FOCUS-CI
Enrollment
23
Registered
2010-02-04
Start date
2011-01-31
Completion date
2014-11-30
Last updated
2016-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Combat Disorders, Stress Disorders, Traumatic Stress Disorders

Keywords

intervention, combat wounded, family, Focus-CI

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.

Interventions

BEHAVIORALStandard 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.

BEHAVIORALFOCUS-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

Sponsors

U.S. Army Medical Research and Development Command
CollaboratorFED
Henry M. Jackson Foundation for the Advancement of Military Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
parent and child distress (including mental health service usage, symptoms of PTSD and Depression)every 12 months

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026