Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00283153




Registration number
NCT00283153
Ethics application status
Date submitted
24/01/2006
Date registered
27/01/2006
Date last updated
4/08/2014

Titles & IDs
Public title
Affect Recognition: Enhancing Performance of Persons With Acquired Brain Injury (ABI)
Scientific title
Controlled Study of Affect Recognition Training for Individuals With Acquired Brain Injury
Secondary ID [1] 0 0
NIDRR H133G080043A
Secondary ID [2] 0 0
DR-050573-BW-2300
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired Brain Injury (Including Stroke) 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Facial Affect Recognition Training
Other interventions - Stories of Emotional Inference

Experimental: FAR - Facial affect recognition training (with computer assistance)

Experimental: SEI - Stories of Emotional Inference


BEHAVIORAL: Facial Affect Recognition Training
A series of pictures of faces displaying various emotions are presented one at a time using a computerized training program.Participants are taught to recognize how emotions affect facial features such as the mouth and eyes.Participants are also taught how to recognize their own emotions.

Other interventions: Stories of Emotional Inference
Participants are presented with a series of short stories one at a time. Each story presents various contextual cues regarding the emotions the characters are likely to experience. Participants learn to connect the cues to specific emotions.
Intervention code [1] 0 0
BEHAVIORAL
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Diagnostic Assessment of Nonverbal Affect-Adult Faces (DANVA2-AF)
Timepoint [1] 0 0
Seven months
Primary outcome [2] 0 0
Emotional Inference From Stories Test
Timepoint [2] 0 0
Seven months
Secondary outcome [1] 0 0
Interpersonal Reactivity Index
Timepoint [1] 0 0
Seven Months
Secondary outcome [2] 0 0
Neuropsychiatric Inventory
Timepoint [2] 0 0
Seven Months

Eligibility
Key inclusion criteria
* Age between eighteen and sixty-five years old.
* At minimum, one year post-injury.
* Glasgow Coma Score (GCS) of 12 or less, or stroke with hemi-paresis signifying a moderate to severe acquired brain injury.
* A TBI that resulted in either a closed or open head injury or a stroke that resulted in severe disability
* Perform at least one standard deviation below the norm on the DANVA2-Adult Faces test, a standardized assessment of facial affect recognition.
* Verbally able to express a basic understanding of emotional descriptors (e.g. Happy, sad, angry, fearful).
* Demonstrate basic comprehension for short paragraphs presented in 2 ways: 1)auditorily and 2)silent reading. This measure is part of the Discourse Comprehension Test.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Diagnosed mental illness.
* Uncorrected visual acuity.
* Uncorrected hearing impairment.
* Perceptual impairment (visual neglect and/or visual discrimination).
* Impaired verbal expression/ aphasia
* Alcohol or substance abuse.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2014
Sample size
Target
Accrual to date
Final
71
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
New Zealand
State/province [4] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Other
Name
University at Buffalo
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
U.S. Department of Education
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Massey University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Wake Forest University Health Sciences
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Brock University
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Barry Willer, Ph.D.
Address 0 0
University at Buffalo, Department of Psychiatry
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents


Results not provided in https://clinicaltrials.gov/study/NCT00283153