NCT03376373

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2016

Completed
1 year until next milestone

First Posted

Study publicly available on registry

December 18, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

3.3 years

First QC Date

December 18, 2016

Last Update Submit

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

EXPERIMENTAL

Neurofeedback for FER

Behavioral: neurofeedback

control

NO INTERVENTION

waiting list

Interventions

neurofeedbackBEHAVIORAL

real-time feedback on accuracy of emotion recognition

active

Eligibility Criteria

Age16 Years - 29 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

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

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Officials

  • Richey

    Virginia Polytechnic Institute and State University

    PRINCIPAL INVESTIGATOR

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

Locations