Neurotherapy to Promote Emotion Recognition in Autism
1 other identifier
interventional
28
1 country
1
Brief Summary
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder, more prevalent than previously thought and heterogeneous in expression, though uniformly characterized by severe social disability. The social disability that defines ASD pervades other areas of adaptive behavior, is predictive of secondary mental health problems, and adversely affects long-term outcome. Although ASD is a chronic condition, there has been little research on interventions for adults with ASD. This study proposes to first establish the neural plasticity of specific brain mechanisms underlying difficulties with facial emotion recognition, a core deficit believed to be pivotal in the behavioral expression of ASD-social disability. The investigators will then develop a novel, computer-based intervention using real-time feedback, to the user, to ameliorate emotion recognition deficits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 18, 2016
CompletedFirst Posted
Study publicly available on registry
December 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedSeptember 16, 2020
September 1, 2020
3.3 years
December 18, 2016
September 12, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
facial emotion recognition (RMET)
Change in facial emotion recognition 5 weeks after baseline appointment
5 weeks
Study Arms (2)
active
EXPERIMENTALNeurofeedback for FER
control
NO INTERVENTIONwaiting list
Interventions
Eligibility Criteria
You may qualify if:
- diagnosis of ASD
You may not qualify if:
- No severe psychopathology which warrants other immediate treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Child Study Center
Blacksburg, Virginia, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richey
Virginia Polytechnic Institute and State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- independent evaluators are masked to condition assignment
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 18, 2016
First Posted
December 18, 2017
Study Start
September 1, 2016
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
September 16, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share