Acute Cognitive and Neurobehavioral Intervention: Efficacy Evaluation

This study has been completed.
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00205569
First received: September 12, 2005
Last updated: February 21, 2012
Last verified: February 2009

September 12, 2005
February 21, 2012
October 2002
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Complete list of historical versions of study NCT00205569 on ClinicalTrials.gov Archive Site
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Acute Cognitive and Neurobehavioral Intervention: Efficacy Evaluation
Acute Cognitive and Neurobehavioral Intervention: Efficacy Evaluation (a Research Project Within the Traumatic Brain Injury Model System Grant)

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Individuals with traumatic brain injury requiring inpatient rehabilitation and admitted to Virginia Commonwealth University's Medical College of Virginia Hospitals acutely after injury.

Traumatic Brain Injury
Behavioral: First Steps Educational Curriculum
10 sessions with the research participant to review an educational curriculum regarding brain injury rehabilitation and community reintegration
1
Individuals with traumatic brain injury requiring inpatient rehabilitation.
Intervention: Behavioral: First Steps Educational Curriculum
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
October 2008
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00205569
H133A02051603, H133A020516
No
Virginia Commonwealth University
Virginia Commonwealth University
U.S. Department of Education
Principal Investigator: Jeffrey S Kreutzer, PhD Virginia Commonwealth University
Virginia Commonwealth University
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP