Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Current therapies for autism target social and language behaviors, but due to the high-level nature of these skills any improvement rarely extends beyond the targeted behavior. This project uses new technology to implement a novel concept for behavioral intervention to improve basic attention and eye movement skills in ASD. Because these basic skills form the foundation for good social communication, training these abilities has the potential to improve a broad spectrum of clinical symptoms, and in young children may affect the course of development.
Autism Spectrum Disorder (ASD) is a lifelong disorder that severely affects the ability to learn and function in a social environment. In typical function, higher level social, language and communication skills develop over the first few years of life and depend upon the critical building blocks of sensory-motor and attention abilities. Similarly in autism, higher level problems with social communication develop over the first two post-natal years and are preceded by subtle but abnormal visual attention and motor skills. Trainings to improve social interaction and communication are the most common of behavioral interventions in ASD. These therapies may improve the specific behaviors that are targets of the training, but rarely do they generalize to broader function or other clinical symptoms. The investigators propose that interventions aimed instead at the early deficits that support social and language skills would be more broadly effective. Because disruption of attention is one of the earliest and most persistent symptoms in autism, and because attention is highly subject to improvement with training, it is an important target for intervention.
This a novel intervention to train the speed and accuracy of attention orienting and eye movement. The training is designed to target attentional behaviors that have been shown to be impaired in autism, including attention orienting, disengagement and shifting, and a restricted attentional field. Because eye movement and attention are tightly linked, eye movement deficits in ASD parallel those found in spatial attention. Eye movements provide a marker for attention and the proposed training is designed to improve speed, accuracy and flexibility of eye movement and attention simultaneously. Training uses a series of entertaining video games to gradually shape behavior using visual and auditory feedback provided in real time. The investigators plan three levels of outcome measures for pre- and post-training to test the effectiveness of the intervention (direct tests of attention and eye movement; tests of improvement in attentional and visual monitoring and speed and accuracy of response in a simulated environment; tests of behavior in an actual social environment). The investigators will conduct clinical trials with control conditions (e.g., standard video games without training elements) with a small sample of ASD children aged 9-15. If this initial work is successful, the long term goal is to develop a readily available inexpensive eyetracker-based system for home use that is suitable for a broad age range of ASD children and adults.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eye Movement Game Control | Experimental | Cognitive Training Eye Motor Training |
|
| Hand Movement Game Control | Active Comparator | Cognitive Training Hand Motor Training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Training | Behavioral | A collection of video games that rely on various aspects of visual behavior (i.e. sustained attention, vigilance, rapid discrimination, etc) for successful play. |
| Measure | Description | Time Frame |
|---|---|---|
| Spatial Attention Baseline | This behavioral task assesses the participant's baseline ability to rapidly and accurately shift visual attention to different spatial locations. This task also reveals whether a participant becomes overly-focused ('stuck') at specific locations. | Pre-intervention |
| Saccadic Eye Movements Baseline | This task uses an eyetracker to measure the baseline speed and accuracy of a participant's saccadic eye movements in response to various stimuli. Measure is accuracy of first saccade in the anti-saccade task. | Pre-intervention |
| Change in Spatial Attention at 8 Weeks | This behavioral task assesses the change in the participant's ability to rapidly and accurately shift visual attention to different spatial locations as a result of the intervention. | end of Week 8 |
| Change in Saccadic Eye Movements at 8 Weeks | This task uses an eyetracker to measure the change in the speed and accuracy of a participant's saccadic eye movements in response to various stimuli as a result of the intervention. Measure is accuracy of first saccade in an anti-saccade task. | end of Week 8 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jeanne Townsend, Ph.D. | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | La Jolla | California | 92093-0959 | United States |
De-identified IPD is being shared through National Institutes of Health (NIH) National Database for Autism Research (NDAR).
Not provided
Data are available to share now (August 8, 2019) and can remain available indefinitely or as long as the National Database for Autism Research is supported.
Data are shared through the National Database for Autism Research. Access is by registration and meeting eligibility requirements established by the National Institutes of Health for data sharing.
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Eye Movement Game Control | Cognitive Training Eye Motor Training Cognitive Training: A collection of video games that rely on various aspects of visual behavior (i.e. sustained attention, vigilance, rapid discrimination, etc) for successful play. Eye Motor Training: Gameplay will be controlled by the player's eye movements (via an eye tracking device) |
| FG001 | Hand Movement Game Control | Cognitive Training Hand Motor Training Cognitive Training: A collection of video games that rely on various aspects of visual behavior (i.e. sustained attention, vigilance, rapid discrimination, etc) for successful play. Hand Motor Training: Gameplay will be controlled by the player's hand movements (via a joystick). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
These are the participants that completed the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Eye Movement Game Control | Cognitive Training Eye Motor Training Cognitive Training: A collection of video games that rely on various aspects of visual behavior (i.e. sustained attention, vigilance, rapid discrimination, etc) for successful play. Eye Motor Training: Game play will be controlled by the player's eye movements (via an eye tracking device) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Spatial Attention Baseline | This behavioral task assesses the participant's baseline ability to rapidly and accurately shift visual attention to different spatial locations. This task also reveals whether a participant becomes overly-focused ('stuck') at specific locations. | All participants who completed the 8 weeks of game-based training were analyzed. | Posted | Mean | Standard Deviation | Percent Correct | Pre-intervention |
|
For each subject, data were collected from initial enrollment for 8 weeks.
Definition not different.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eye Movement Game Control | Cognitive Training Eye Motor Training Cognitive Training: A collection of video games that rely on various aspects of visual behavior (i.e. sustained attention, vigilance, rapid discrimination, etc) for successful play. Eye Motor Training: Gameplay will be controlled by the player's eye movements (via an eye tracking device) |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeanne Townsend, PhD, Professor of Neurosciences | University of California, San Diego | 858-246-1931 | jtownsend@ucsd.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 8, 2019 | Aug 8, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
Not provided
Not provided
This project develops the intervention and includes a small clinical (behavioral) trial for ASD participants. A small number of ASD participants will be randomly assigned to intervention 'games' played by mouse response--the others to gaze-driven response.
Not provided
Not provided
Not provided
Not provided
| Eye Motor Training | Behavioral | Game play will be controlled by the player's eye movements (via an eye tracking device) |
|
| Hand Motor Training | Behavioral | Game play will be controlled by the player's hand movements (via a joystick). |
|
| BG001 |
| Hand Movement Game Control |
Cognitive Training Hand Motor Training Cognitive Training: A collection of video games that rely on various aspects of visual behavior (i.e. sustained attention, vigilance, rapid discrimination, etc) for successful play. Hand Motor Training: Game play will be controlled by the player's hand movements (via a joystick). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Autism Diagnosis | Count of Participants | Participants |
|
| OG001 |
| Hand Movement Game Control |
Cognitive Training Hand Motor Training Cognitive Training: A collection of video games that rely on various aspects of visual behavior (i.e. sustained attention, vigilance, rapid discrimination, etc) for successful play. Hand Motor Training: Gameplay will be controlled by the player's hand movements (via a joystick). |
|
|
| Primary | Saccadic Eye Movements Baseline | This task uses an eyetracker to measure the baseline speed and accuracy of a participant's saccadic eye movements in response to various stimuli. Measure is accuracy of first saccade in the anti-saccade task. | Because of technical difficulties we have only partial data for this measure. | Posted | Mean | Standard Deviation | percent correct direction | Pre-intervention |
|
|
|
| Primary | Change in Spatial Attention at 8 Weeks | This behavioral task assesses the change in the participant's ability to rapidly and accurately shift visual attention to different spatial locations as a result of the intervention. | All participants who completed 8 weeks of training were analyzed. | Posted | Mean | Standard Deviation | Percent Correct | end of Week 8 |
|
|
|
|
| Primary | Change in Saccadic Eye Movements at 8 Weeks | This task uses an eyetracker to measure the change in the speed and accuracy of a participant's saccadic eye movements in response to various stimuli as a result of the intervention. Measure is accuracy of first saccade in an anti-saccade task. | Because of technical difficulties we have data for only part of the sample. | Posted | Mean | Standard Deviation | Percent Correct Direction | end of Week 8 |
|
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Hand Movement Game Control | Cognitive Training Hand Motor Training Cognitive Training: A collection of video games that rely on various aspects of visual behavior (i.e. sustained attention, vigilance, rapid discrimination, etc) for successful play. Hand Motor Training: Gameplay will be controlled by the player's hand movements (via a joystick). | 0 | 2 | 0 | 2 | 0 | 2 |
Not provided
Not provided
Not provided
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |