Expired Study
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Richmond, Virginia 23298


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.


Study summary:

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.


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.


Study is Available At:


Original ID:

H133A02051603


NCT ID:

NCT00205569


Secondary ID:

H133A020516


Study Acronym:


Brief Title:

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)


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Virginia Commonwealth University


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

103


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jeffrey S Kreutzer, PhD
Principal Investigator
Virginia Commonwealth University

Study Dates

Start Date:October 2002
Completion Date:October 2008
Completion Type:Actual
Primary Completion Date:October 2008
Primary Completion Type:Actual
Verification Date:March 2017
Last Changed Date:March 16, 2017
First Received Date:September 12, 2005

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Behavioral
Name:First Steps Educational Curriculum
Description:10 sessions with the research participant to review an educational curriculum regarding brain injury rehabilitation and community reintegration
Arm Name:1

Study Arms

Study Arm Type:Other
Arm Name:1
Description:Individuals with traumatic brain injury requiring inpatient rehabilitation.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Virginia Commonwealth University
Agency Class:U.S. Fed
Agency Type:Collaborator
Agency Name:U.S. Department of Education

Samples and Retentions

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.
Sample Method:Probability Sample

Study References

Reference Type:Results Reference
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.
PMID:16353506

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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