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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
History of Changes
  Purpose

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.


Condition Intervention
Traumatic Brain Injury
 Behavioral: First Steps Educational Curriculum

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acute Cognitive and Neurobehavioral Intervention: Efficacy Evaluation (a Research Project Within the Traumatic Brain Injury Model System Grant)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Virginia Commonwealth University:

Enrollment: 103
Study Start Date: October 2002
Study Completion Date: October 2008
Groups/Cohorts Assigned Interventions
1
Individuals with traumatic brain injury requiring inpatient rehabilitation.
 Behavioral: First Steps Educational Curriculum
10 sessions with the research participant to review an educational curriculum regarding brain injury rehabilitation and community reintegration

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00205569

Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
U.S. Department of Education
Investigators
Principal Investigator: Jeffrey S Kreutzer, PhD Virginia Commonwealth University
  More Information

Additional Information:
Virginia Commonwealth University Traumatic Brain Injury Model System  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00205569     History of Changes
Other Study ID Numbers: H133A02051603, H133A020516
Study First Received: September 12, 2005
Last Updated: February 21, 2012
Health Authority: United States: Federal Government

Keywords provided by Virginia Commonwealth University:
brain injury, acute rehabilitation

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013