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Clinical Trials/NCT01062022
NCT01062022
Terminated
N/A

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

Henry M. Jackson Foundation for the Advancement of Military Medicine3 sites in 1 country23 target enrollmentJanuary 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stress Disorders
Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Enrollment
23
Locations
3
Primary Endpoint
parent and child distress (including mental health service usage, symptoms of PTSD and Depression)
Status
Terminated
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
November 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

parent and child distress (including mental health service usage, symptoms of PTSD and Depression)

Time Frame: every 12 months

Secondary Outcomes

  • 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)
  • Parent Functioning (including substance use, parental efficacy, parental satisfaction, parenting behavior, social support and posttraumatic growth)(at 12 and 24 month followups)

Study Sites (3)

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