An interventional study of Cognitive Training and Eye Motor Training in Autistic Disorder and Autism Spectrum Disorder, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 9 Years to 25 Years. Per ClinicalTrials.gov, last updated 2019-12-04.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment
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.
1,727 studies on the registry are indexed under Autism Spectrum Disorder; 504 are open to participants now.
This study's enrollment of 30 is below the median of 52 across 1,371 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
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Exclusion Criteria:
Cognitive Training Eye Motor Training
Behavioral: Cognitive Training · Behavioral: Eye Motor Training
Cognitive Training Hand Motor Training
Behavioral: Cognitive Training · Behavioral: Hand Motor 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.
Game play will be controlled by the player's eye movements (via an eye tracking device)
Game play will be controlled by the player's hand movements (via a joystick).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: end of Week 8
| Milestone | Eye Movement Game Control | Hand Movement Game Control |
|---|---|---|
| Started | 28 | 2 |
| Completed | 23 | 2 |
| Not completed | 5 | 0 |
| Withdrew: Withdrawal by subject | 5 | 0 |
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.
| Percent Correct | Eye Movement Game Control | Hand Movement Game Control |
|---|---|---|
| Spatial Attention Baseline | 80.3 ± 14.8 | 43.0 ± 26.9 |
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.
| percent correct direction | Eye Movement Game Control | Hand Movement Game Control |
|---|---|---|
| Saccadic Eye Movements Baseline | 49.20 ± 2.8 | — |
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.
| Percent Correct | Eye Movement Game Control | Hand Movement Game Control |
|---|---|---|
| Change in Spatial Attention at 8 Weeks | 88.07 ± 13.9 | 77.5 ± 16.3 |
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.
| Percent Correct Direction | Eye Movement Game Control | Hand Movement Game Control |
|---|---|---|
| Change in Saccadic Eye Movements at 8 Weeks | 59.4 ± 2.7 | — |
Collected over For each subject, data were collected from initial enrollment for 8 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Eye Movement Game Control | 0/28 (0%) | 0/28 (0%) | 0/28 (0%) |
| Hand Movement Game Control | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
These are the participants that completed the study.
| Age, Continuous(years) | Eye Movement Game Control | Hand Movement Game Control | Total |
|---|---|---|---|
| Mean | 17.31 ± 4.3 | 21.41 ± .4 | 17.62 ± 4.3 |
| Sex: Female, Male(Participants) | Eye Movement Game Control | Hand Movement Game Control | Total |
|---|---|---|---|
| Female | 5 | 0 | 5 |
| Male | 18 | 2 | 20 |
| Race (NIH/OMB)(Participants) | Eye Movement Game Control | Hand Movement Game Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 4 | 0 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 12 | 2 | 14 |
| More than one race | 7 | 0 | 7 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Eye Movement Game Control | Hand Movement Game Control | Total |
|---|---|---|---|
| United States | 23 | 2 | 25 |
| Autism Diagnosis(Participants) | Eye Movement Game Control | Hand Movement Game Control | Total |
|---|---|---|---|
| Count of participants | 23 | 2 | 25 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified IPD is being shared through National Institutes of Health (NIH) National Database for Autism Research (NDAR).
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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University of California, San Diego