Acute Cognitive and Neurobehavioral Intervention: Efficacy Evaluation

Traumatic Brain Injury Clinical Trial

Official title:

Acute Cognitive and Neurobehavioral Intervention: Efficacy Evaluation (a Research Project Within the Traumatic Brain Injury Model System Grant)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00205569
• Other study ID #: H133A02051603
• Secondary ID: H133A020516
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: March 16, 2017
• Start date: October 2002
• Est. completion date: October 2008

Study information

• Verified date: March 2017
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Behavioral:
• First Steps Educational Curriculum
10 sessions with the research participant to review an educational curriculum regarding brain injury rehabilitation and community reintegration

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	U.S. Department of Education

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation