Clinical trial NCT00205569: Acute Cognitive and Neurobehavioral Intervention: Efficacy Evaluation
Official title: Acute Cognitive and Neurobehavioral Intervention: Efficacy Evaluation (a Research Project Within the Traumatic Brain Injury Model System Grant)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Keywords: brain injury, acute rehabilitation
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2005-09-20
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with traumatic brain injury requiring inpatient rehabilitation and admitted to Virginia Commonwealth University's Medical College of Virginia Hospitals acutely after injury.

Brief summary: To learn more about behavior and everyday functioning after brain injury, and to learn if behavior and functioning gets better with more education about changes after brain injury.

Detailed description: To evaluate the efficacy of the First Steps intervention for improving neurobehavioral functioning, functional status, and life satisfaction, and for increasing knowledge about TBI and compensatory strategies. The First Steps program was developed to address the neurobehavioral and emotional concerns of survivors of TBI during the course of inpatient rehabilitation. Program format and content reflects clinical experience and extensive research review. Input from survivors, family members, and rehabilitation staff trained in working with the TBI population has also helped shape the implementation protocol. The foundation of the protocol is a curriculum \[Niemeier, J., Kreutzer, J., \& Taylor, L. (2005). Acute cognitive and neurobehavioral intervention for individuals with acquired brain injury: Preliminary outcome data. Neuropsychological Rehabilitation, 15(2), 129-146.\] The First Steps curriculum consists of ten lessons and was developed to address the common needs, issues, and concerns of TBI survivors admitted acutely for inpatient rehabilitation.

Eligibility criteria: Inclusion Criteria:

* adults (18 years or older) who have experienced a TBI (damage to brain tissue caused by an external mechanical force as evidenced by: loss of consciousness due to brain trauma, or post traumatic amnesia, or skull fracture, or objective neurological findings that can be reasonably attributed to TBI on physical examination or mental status examination).

Exclusion Criteria:

* imminent risk of psychiatric hospitalization, or in imminent danger of hurting themselves or others.
* unable to tolerate treatment sessions due to physical, cognitive, behavioral, or other difficulties.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Jeffrey S Kreutzer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Niemeier JP, Kreutzer JS, Taylor LA. Acute cognitive and neurobehavioural intervention for individuals with acquired brain injury: preliminary outcome data. Neuropsychol Rehabil. 2005 May;15(2):129-46. doi: 10.1080/09602010443000083.