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

NCT01062022 | Terminated

• 2 other identifiers: G188NIW81XWH-08-2-0650
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 3

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.

Conditions

Stress Disorders; Combat Disorders; Traumatic Stress Disorders

Keywords

intervention; combat wounded; family; Focus-CI

Outcome Measures

Primary Outcomes (1)

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

  every 12 months

Secondary Outcomes (4)

• Participant Satisfaction with Intervention

  every 12 months

• Clinician Satisfaction with Intervention

  months 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

Study Arms (2)

Control - Standard of Care

ACTIVE COMPARATOR

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.

Behavioral: Standard of Care

FOCUS-CI

ACTIVE COMPARATOR

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.

Behavioral: FOCUS-CI

Interventions

Standard of Care BEHAVIORAL

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.

Also known as: comparison group, standard of care

Control - Standard of Care

FOCUS-CI BEHAVIORAL

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

Also known as: FOCUS-CI, Families OverComing Under Stress-Combat Injury

FOCUS-CI

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (3)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5001, United States

Location

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

Location

Madigan Army Medical Center

Seattle, Washington, 98431, United States

Location

Related Links

• USUHS
• Henry M. Jackson Foundation for the Advancement of Military Medicine

MeSH Terms

Conditions

Stress Disorders, Traumatic; Combat Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Stephen Cozza, MD

  Uniformed Services University of the Health Sciences (USUHS)

  PRINCIPAL INVESTIGATOR

• Robert Ursano, MD

  Uniformed Services University of the Health Sciences (USUHS)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2010
• First Posted: February 4, 2010
• Study Start: January 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: August 18, 2016

Record last verified: 2016-08

Locations

US (3)