Autism Spectrum Disorder
Conditions
Brief summary
This study aims to demonstrate that improvements in identification of social clues (and improvement of overall social behaviour) in subjects with ASD can be achieved using social games together with a BCI setup. The primary goal is to ensure increased rate of responses to joint attention cues. Intervention Type is a Device (brain computer interface using EEG). Structure: (1) initial eligibility screening (within 1 week after admission), (2) pre-intervention (first week of study, baseline outcome measures and additional evaluations), (3) intervention process (16 weeks), (4) post-intervention (outcome measures and additional evaluations), and (5) follow-up (outcome measures at 6 months).
Detailed description
Clinical research has demonstrated that ASD children have deficits in the interpretation of others intentions from gaze-direction or other social attention cues (Baron-Cohen, Baldwin, & Crowson, 1997). The purpose of the study is to investigate whether a brain computer interface (BCI) using electroencephalographic (EEG) signals can be used to train social cognition skills (in particular interpretation of gaze direction pointing to objects of interest) in ASD patients and whether this improves clinical symptoms. The intervention comprehends seven BCI sessions spread over four months. The first four sessions are planned to occur weekly, and the rest monthly. In each session, the subject is asked to identify objects of interest based on the gaze direction of an avatar. The subject response is interpreted from the EEG signal (using the P300 component, as established in our previous work).
Interventions
DEVICEBCI to train joint attention in ASD
The intervention comprehends seven BCI sessions spread over four months. The first four sessions are planned to occur weekly, and the rest monthly. In each session, the subject is asked to identify objects of interest based on the gaze direction of an avatar. The subject response is interpreted from the EEG signal (using the P300 component, as established in our previous work).
Sponsors
University of Coimbra
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
* Positive diagnostic results for ASD in: Autism Diagnostic Interview-Revised; Autism Diagnostic Observation Schedule; The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
Exclusion criteria
* Global Intelligence Quotient \< 80 * Associated medical condition such as epilepsy, neurocutaneous or other genetic syndromes, or other usual comorbidity in ASD samples
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| JAAT_NoFace | 16 weeks, and 6 months after intervention | Number of fixations on the target object of the joint attention animation of an avatar after the animation starts (e.g. looking at, pointing at) in the Joint-attention assesment task - JAAT\_NoFace with no previous fixation on avatar face.. We will use a new task/realistic game that will challenge the detection of initiation of joint attention cues (from avatars - gaze or pointing). The number of correct responses (to particular objects and not to non-object parts of the scene) will be recorded. We will also record incorrect responses to non-pointing body gestures. |
| JAAT_Face | 16 weeks, and 6 months after intervention | Number of fixations on the target object of the joint attention animation of an avatar after the animation starts (e.g. looking at, pointing at) in the Joint-attention assesment task - JAAT\_NoFace with previous fixation on avatar face.. We will use a new task/realistic game that will challenge the detection of initiation of joint attention cues (from avatars - gaze or pointing). The number of correct responses (to particular objects and not to non-object parts of the scene) will be recorded. We will also record incorrect responses to non-pointing body gestures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ATEC - Autism Treatment Evaluation Checklist | 16 weeks, and Follow-Up (6 months after intervention) | Autism Treatment Evaluation Checklist (ATEC) evaluates the effectiveness of autism treatments - a 1-page form designed to be completed by parents or caretakers. It consists of 4 subtests: I. Speech/Language Communication (14 items, min.0-max.28); II. Sociability (20 items, min.0-max.40); III. Sensory/Cognitive Awareness (18 items, min.0-max.36); and IV. Health/Phys./Behavior (25 items, min.0-max.75). Total score (sum) ranges from min.0-max.179. The results reported here correspond to the total ATEC score to be used for comparison at a later date. The lower the score, the fewer the problems. |
| VABS - Vineland Adaptive Behaviour Scale | 16 weeks, and Follow-Up (6 months after intervention) | The Vineland Adaptive Behaviour Scale (VABS) is a semi-structured interview designed to assess global adaptive functioning, composed by 3 main domains: Communication COM, Daily Living Skills DLS and Socialization SOC. The Adaptive Behaviour Composite ABC (total score) is the sum of the raw scores from the main domains. These are transformed in standard scores (m.=100;std.=15). The higher the score, better is the adaptive behavior. Sparrow, S., Balla, D., & Cicchetti, D. (1984). Vineland Adaptative Behaviour Scales: Interview edition, Survey form. Circle Pines, MN: American Guidance Service. |
Other
| Measure | Time frame | Description |
|---|---|---|
| HADS - Hospital Anxiety & Depression Scale | 16 weeks | 21-item measure of clinical depression |
| Debriefing Interview Questionnaire | 16 weeks | Covers: strategies; general experience of the process; adverse effects; |
| POMS - Profile of Mood States | 16 weeks plus 6 months | — |
Participant flow
Recruitment details
A total of 15 (plus 3 in case of drop outs) participants will be recruited. We expect to recruit one subject each three weeks. We recruited the first participant on the second semester of 2015 and the study last up to 82 weeks (including follow-up).
Participants by arm
| Arm | Count |
|---|---|
| High Functioning ASD Adolescents and Adults The eligible patients for the study should be high functioning ASD adolescents and adults.
These participants should also meet all the following inclusion criteria and none of the exclusion criteria. All queries about patient eligibility should be directed to Susana Mouga before registration.
Positive diagnostic results for ASD in:
* Autism Diagnostic Interview-Revised;
* Autism Diagnostic Observation Schedule;
* The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | High Functioning ASD Adolescents and Adults |
|---|---|
| Age, Continuous | 22.333 years STANDARD_DEVIATION 5.5 |
| ATEC - Autism Treatment Evaluation Checklist | 35.57 score on a scale STANDARD_DEVIATION 12.53 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 15 Participants |
| JAAT_Face | 10.67 Correct Fixations STANDARD_DEVIATION 9.35 |
| JAAT_NoFace | 16.33 Correct Fixations STANDARD_DEVIATION 9.36 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment Portugal | 15 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 15 Participants |
| VABS - Vineland Adaptive Behaviour Scale VABS_ABC_baseline | 65.73 units on a scale STANDARD_DEVIATION 15.56 |
| VABS - Vineland Adaptive Behaviour Scale VABS_COM_baseline | 68.27 units on a scale STANDARD_DEVIATION 21.53 |
| VABS - Vineland Adaptive Behaviour Scale VABS_DLS_baseline | 77.53 units on a scale STANDARD_DEVIATION 14.05 |
| VABS - Vineland Adaptive Behaviour Scale VABS_SOC_baseline | 65.80 units on a scale STANDARD_DEVIATION 16.79 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
JAAT_Face
Number of fixations on the target object of the joint attention animation of an avatar after the animation starts (e.g. looking at, pointing at) in the Joint-attention assesment task - JAAT\_NoFace with previous fixation on avatar face.. We will use a new task/realistic game that will challenge the detection of initiation of joint attention cues (from avatars - gaze or pointing). The number of correct responses (to particular objects and not to non-object parts of the scene) will be recorded. We will also record incorrect responses to non-pointing body gestures.
Time frame: 16 weeks, and 6 months after intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Functioning ASD Adolescents and Adults | JAAT_Face | 16 weeks | 7.80 Correct Fixations | Standard Deviation 8.77 |
| High Functioning ASD Adolescents and Adults | JAAT_Face | 6 months after intervention | 7.53 Correct Fixations | Standard Deviation 8.11 |
Primary
JAAT_NoFace
Number of fixations on the target object of the joint attention animation of an avatar after the animation starts (e.g. looking at, pointing at) in the Joint-attention assesment task - JAAT\_NoFace with no previous fixation on avatar face.. We will use a new task/realistic game that will challenge the detection of initiation of joint attention cues (from avatars - gaze or pointing). The number of correct responses (to particular objects and not to non-object parts of the scene) will be recorded. We will also record incorrect responses to non-pointing body gestures.
Time frame: 16 weeks, and 6 months after intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Functioning ASD Adolescents and Adults | JAAT_NoFace | 16 weeks | 13.73 Correct Fixations | Standard Deviation 8.19 |
| High Functioning ASD Adolescents and Adults | JAAT_NoFace | 6 months after intervention | 15.00 Correct Fixations | Standard Deviation 10.02 |
Secondary
ATEC - Autism Treatment Evaluation Checklist
Autism Treatment Evaluation Checklist (ATEC) evaluates the effectiveness of autism treatments - a 1-page form designed to be completed by parents or caretakers. It consists of 4 subtests: I. Speech/Language Communication (14 items, min.0-max.28); II. Sociability (20 items, min.0-max.40); III. Sensory/Cognitive Awareness (18 items, min.0-max.36); and IV. Health/Phys./Behavior (25 items, min.0-max.75). Total score (sum) ranges from min.0-max.179. The results reported here correspond to the total ATEC score to be used for comparison at a later date. The lower the score, the fewer the problems.
Time frame: 16 weeks, and Follow-Up (6 months after intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Functioning ASD Adolescents and Adults | ATEC - Autism Treatment Evaluation Checklist | 16 weeks | 24.29 score on a scale | Standard Deviation 12.9 |
| High Functioning ASD Adolescents and Adults | ATEC - Autism Treatment Evaluation Checklist | Follow-up (6 months after intervention) | 18.43 score on a scale | Standard Deviation 11.77 |
Secondary
VABS - Vineland Adaptive Behaviour Scale
The Vineland Adaptive Behaviour Scale (VABS) is a semi-structured interview designed to assess global adaptive functioning, composed by 3 main domains: Communication COM, Daily Living Skills DLS and Socialization SOC. The Adaptive Behaviour Composite ABC (total score) is the sum of the raw scores from the main domains. These are transformed in standard scores (m.=100;std.=15). The higher the score, better is the adaptive behavior. Sparrow, S., Balla, D., & Cicchetti, D. (1984). Vineland Adaptative Behaviour Scales: Interview edition, Survey form. Circle Pines, MN: American Guidance Service.
Time frame: 16 weeks, and Follow-Up (6 months after intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Functioning ASD Adolescents and Adults | VABS - Vineland Adaptive Behaviour Scale | VABS_COM_16 weeks | 71.33 units on a scale | Standard Deviation 21.62 |
| High Functioning ASD Adolescents and Adults | VABS - Vineland Adaptive Behaviour Scale | VABS_COM_Follow-up (6 months after intervention) | 73.14 units on a scale | Standard Deviation 17.29 |
| High Functioning ASD Adolescents and Adults | VABS - Vineland Adaptive Behaviour Scale | VABS_DLS_16 weeks | 81.60 units on a scale | Standard Deviation 14.46 |
| High Functioning ASD Adolescents and Adults | VABS - Vineland Adaptive Behaviour Scale | VABS_DLS_Follow-up (6 months after intervention) | 86.29 units on a scale | Standard Deviation 14.02 |
| High Functioning ASD Adolescents and Adults | VABS - Vineland Adaptive Behaviour Scale | VABS_SOC_16 weeks | 67.67 units on a scale | Standard Deviation 16.18 |
| High Functioning ASD Adolescents and Adults | VABS - Vineland Adaptive Behaviour Scale | VABS_SOC_Follow-up (6 months after intervention) | 71.14 units on a scale | Standard Deviation 16.11 |
| High Functioning ASD Adolescents and Adults | VABS - Vineland Adaptive Behaviour Scale | VABS_ABC_16 weeks | 69.00 units on a scale | Standard Deviation 15.2 |
| High Functioning ASD Adolescents and Adults | VABS - Vineland Adaptive Behaviour Scale | VABS_ABC_Follow-up (6 months after intervention) | 72.00 units on a scale | Standard Deviation 13.65 |
Other Pre-specified
Debriefing Interview Questionnaire
Covers: strategies; general experience of the process; adverse effects;
Time frame: 16 weeks
Other Pre-specified
HADS - Hospital Anxiety & Depression Scale
21-item measure of clinical depression
Time frame: 16 weeks
Other Pre-specified
POMS - Profile of Mood States
Time frame: 16 weeks plus 6 months