Acute Cognitive and Neurobehavioral Intervention: Efficacy Evaluation

NCT ID: NCT00205569

Last Updated: 2017-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-10-31

Study Completion Date

2008-10-31

Brief Summary

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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

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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.

Conditions

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Traumatic Brain Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Individuals with traumatic brain injury requiring inpatient rehabilitation.

First Steps Educational Curriculum

Intervention Type BEHAVIORAL

10 sessions with the research participant to review an educational curriculum regarding brain injury rehabilitation and community reintegration

Interventions

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First Steps Educational Curriculum

10 sessions with the research participant to review an educational curriculum regarding brain injury rehabilitation and community reintegration

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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U.S. Department of Education

FED

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey S Kreutzer, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 16353506 (View on PubMed)

Other Identifiers

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H133A020516

Identifier Type: -

Identifier Source: secondary_id

H133A02051603

Identifier Type: -

Identifier Source: org_study_id

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