More than 1.4 million people a year in the United States begin confronting life with the medical, cognitive, and psychosocial challenges resulting from traumatic brain injury (TBI) (82). A range of cognitive impairments commonly observed following injury increase caregiver burden (55, 56) as well as per-person lifetime costs for care and support of survivors of TBI, estimated at $600,000 to $1,875,000 (26). Our long-term goal is to lessen these burdens through improving the functional status of patients with TBI by providing an evidence-based, comprehensive, and brief, acute-care intervention, First Steps Acute Neurobehavioral and Cognitive Intervention (FANCI) (73-75). The 10-lesson, manualized FANCI Program will be tested in a controlled, randomized study. Specific hypotheses are that 1) FANCI will result in more improvement in functional status compared to standard interdisciplinary rehabilitation treatment and 2) FANCI will result in more improvement on measures of neurobehavioral functioning compared to standard rehabilitation care for patients with moderate to severe TBI. We base these hypotheses on the observations that 1) providing information about symptoms, treatment, and coping results in reduced symptom intensity and duration for patients with TBI (35, 68, 75, 77), and 2) inpatient participants enrolled in recent FANCI pilot studies learned >80% of the Program curriculum (75), and 3) the most recent FANCI pilot study participants significantly better functional outcomes at discharge than controls. The specific aims of the proposed study are to (1) evaluate the efficacy of FANCI for improving functional status using the FIM, (2) examine the impact of FANCI on broader outcome measures of general emotional and behavioral functioning and productive activity in the community as measured post-treatment and at 6-month follow-up, (3) examine contributions of participant injury severity and cognitive status at time of treatment to treatment outcome and treatment response, (4) examine contributions of the treatment variables of lesson topic and mastery, caregiver presence, and concurrent therapies on treatment outcome and treatment response for inpatients with TBI. Primary outcome measure is the (FIM). We will secondarily compare scores on the Disability Rating Scale (DRS), Neurobehavioral Rating Scale (NRS), Glasgow Outcome Scale-Extended (GOSE), Rehabilitation Intensity of Therapy Scale (RITS), and the Frontal Systems Behavior Scale (FRsBe).
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