Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
AutismEyes Eyetracking system Autism Symptoms Index (ASI) |
AutismEYES is an eye tracking device that is an objective, quantitative set of measurements that has been validated as both a diagnostic tool and measure of severity in children with ASD. |
Baseline to Week 12 |
|
| Other |
Telehealth Functional Behavior Analysis (Tele-FBA) |
A Functional Analysis (FA) evaluates variables that influence the occurrence of problem behavior by directly evaluating behaviors in natural settings. |
Baseline to Week 12 |
|
| Other |
Autism Screening Instrument for Educational Planning- 3rd Edition Sample of Vocal Behavior (ASIEP-3 SVB) Vocalization Score |
The Autism Screening Instrument for Educational Planning - 3rd Edition (ASIEP-3) is a 12-minute play-based assessment that evaluates social interactions and social responses. Videos of the session are coded for interactions, social avoidance, and negative behaviors (self-stimulatory, aggression). The vocal behavior is also coded as a separate domain to provide a sample of language function. |
Baseline to Week 12 |
|
| Other |
Parent/Caregiver Improvement Scale |
The Parent/Caregiver Improvement Scale is caregiver-completed questionnaire that assesses improvement in domains of communication skills, social skills, daily living skills and overall behavioral symptoms. A 7-point Likert scale is used for each domain with scores ranging from "very much improved" (1) to "very much worse" (7). |
Baseline to Week 12 |
|
| Primary |
Aberrant Behavior Checklist- 2nd Edition (ABC-2): Irritability subscale raw score |
The Aberrant Behavior Checklist- 2nd Edition (ABC-2) is a standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials. The ABC-2 is a 58-item questionnaire and measures domains of Irritability, Lethargy/Social Withdrawal, Stereotypic Behavior, Hyperactivity/noncompliance, and Inappropriate Speech. Behaviors are assessed using a 4-point Likert scale. Scores range from "not at all a problem" (0) to "the problem is severe in degree" (3). The Irritability subscale range is from 0 to 45. |
Baseline to Week 12 |
|
| Secondary |
Aberrant Behavior Checklist- 2nd Edition (ABC-2): Lethargy/Social Withdrawal subscale |
The Aberrant Behavior Checklist- 2nd Edition (ABC-2) is a standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials. The ABC-2 is a 58-item questionnaire and measures domains of Irritability, Lethargy/Social Withdrawal, Stereotypic Behavior, Hyperactivity/noncompliance, and Inappropriate Speech. Behaviors are assessed using a 4-point Likert scale. Scores range from "not at all a problem" (0) to "the problem is severe in degree" (3). The Lethargy/Social Withdrawal subscale range is from 0 to 48. |
Baseline to Week 12 |
|
| Secondary |
Aberrant Behavior Checklist- 2nd Edition (ABC-2): Stereotypic Behavior subscale |
The Aberrant Behavior Checklist- 2nd Edition (ABC-2) is a standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials. The ABC-2 is a 58-item questionnaire and measures domains of Irritability, Lethargy/Social Withdrawal, Stereotypic Behavior, Hyperactivity/noncompliance, and Inappropriate Speech. Behaviors are assessed using a 4-point Likert scale. Scores range from "not at all a problem" (0) to "the problem is severe in degree" (3). The Stereotypic Behavior subscale range is from 0 to 21. |
Baseline to Week 12 |
|
| Secondary |
Aberrant Behavior Checklist- 2nd Edition (ABC-2): Inappropriate Speech subscale |
The Aberrant Behavior Checklist- 2nd Edition (ABC-2) is a standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials. The ABC-2 is a 58-item questionnaire and measures domains of Irritability, Lethargy/Social Withdrawal, Stereotypic Behavior, Hyperactivity/noncompliance, and Inappropriate Speech. Behaviors are assessed using a 4-point Likert scale. Scores range from "not at all a problem" (0) to "the problem is severe in degree" (3). The Inappropriate Speech subscale range is from 0 to 12. |
Baseline to Week 12 |
|
| Secondary |
Aberrant Behavior Checklist- 2nd Edition (ABC-2): Hyperactivity/Noncompliance subscale |
The Aberrant Behavior Checklist- 2nd Edition (ABC-2) is a standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials. The ABC-2 is a 58-item questionnaire and measures domains of Irritability, Lethargy/Social Withdrawal, Stereotypic Behavior, Hyperactivity/noncompliance, and Inappropriate Speech. Behaviors are assessed using a 4-point Likert scale. Scores range from "not at all a problem" (0) to "the problem is severe in degree" (3). The Hyperactivity/Noncompliance subscale range is from 0 to 48. |
Baseline to Week 12 |
|
| Secondary |
Anxiety, Depression, and Mood Scale (ADAMS): Total Score |
The Anxiety, Depression, and Mood Scale (ADAMS) is a 28-item parent-report scale designed for individuals with disabilities to measure domains of anxiety (range 0 - 21), depression (range 0 - 21), hyperactivity (range 0 - 15), social avoidance (range 0 - 21), and obsessive/compulsive behavior (range 0 - 9). The total score is the sum of all items (range 0 - 87). Items are rated on a scale of "not a problem" (0) to "severe problem" (3). |
Baseline to Week 12 |
|
| Secondary |
Anxiety, Depression, and Mood Scale (ADAMS): General Anxiety subscale |
The Anxiety, Depression, and Mood Scale (ADAMS) is a 28-item parent-report scale designed for individuals with disabilities to measure domains of anxiety (range 0 - 21), depression (range 0 - 21), hyperactivity (range 0 - 15), social avoidance (range 0 - 21), and obsessive/compulsive behavior (range 0 - 9). The total score is the sum of all items (range 0 - 87). Items are rated on a scale of "not a problem" (0) to "severe problem" (3). |
Baseline to Week 12 |
|
| Secondary |
Anxiety, Depression, and Mood Scale (ADAMS): Social Avoidance subscale |
The Anxiety, Depression, and Mood Scale (ADAMS) is a 28-item parent-report scale designed for individuals with disabilities to measure domains of anxiety (range 0 - 21), depression (range 0 - 21), hyperactivity (range 0 - 15), social avoidance (range 0 - 21), and obsessive/compulsive behavior (range 0 - 9). The total score is the sum of all items (range 0 - 87). Items are rated on a scale of "not a problem" (0) to "severe problem" (3). |
Baseline to Week 12 |
|
| Secondary |
Social Responsiveness Scale - 2nd Edition (SRS-2): total T-score |
The Social Responsiveness Scale - 2nd Edition (SRS-2) is a standardized questionnaire that provides T-scores in domains of social communication, social motivation, social cognition, and restrictive/repetitive behaviors. The SRS-2 Total T-score ranges from 30 to =90 with higher scores indicating greater deficiencies in reciprocal social behavior. |
Baseline to Week 12 |
|
| Secondary |
Ohio Autism Clinical Impressions Scale - Severity (OACIS-S) scale |
The Ohio Autism Clinical Impressions Scale - Severity (OACIS-S) is a 10-item, clinician completed measures based upon interview and/or observation. The OACIS-S assesses severity in domains of social interaction, aberrant behavior (including irritability and aggressive behavior), repetitive or ritualistic behavior, verbal communication, nonverbal communication skills, hyperactivity and inattention, anxiety and fearfulness, sensory sensitivities, restricted and narrow interests, and a global rating of autism severity. A 7-point Likert scale is used with scores ranging from "normal" (1) to "among the most severe" (7). |
Baseline to Week 12 |
|
| Secondary |
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) scale |
The Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) is a 10-item, clinician completed measures based upon interview and/or observation. The OACIS-I assesses improvement in domains of social interaction, aberrant behavior (including irritability and aggressive behavior), repetitive or ritualistic behavior, verbal communication, nonverbal communication skills, hyperactivity and inattention, anxiety and fearfulness, sensory sensitivities, restricted and narrow interests, and a global rating of autism severity. A 7-point Likert scale is used with scores ranging from "very much improved" (1) to "very much worse" (7). |
Baseline to Week 12 |
|
| Secondary |
Autism Screening Instrument for Educational Planning - 3rd Edition (ASIEP - 3): Interaction Assessment Autism Interaction Score |
The Autism Screening Instrument for Educational Planning - 3rd Edition (ASIEP-3) is a 12-minute play-based assessment that evaluates social interactions and social responses. Videos of the session are coded for interactions, social avoidance, and negative behaviors (self-stimulatory, aggression). The vocal behavior is also coded as a separate domain to provide a sample of language function. |
Baseline to Week 12 |
|
| Secondary |
Repetitive Behavior Scale - Revised (RBS-R) |
The Repetitive Behavior Scale - Revised (RBS-R) is a caregiver-completed, 43-item questionnaire assessing repetitive behaviors with 6 subscales: stereotyped (range 0 - 27), ritualistic/sameness (range 0 - 36) , self-injurious (range 0 - 24), compulsive (range 0 - 18), and restricted (range 0 - 9). The total score ranges from 0 to 129, with a higher score indicating more significant problems with repetitive behaviors. Repetitive Behaviors are assessed using a 4-point Likert scale. Scores range from "behavior does not occur" (0) to "behavior occurs and is a severe problem" (3). |
Baseline to Week 12 |
|
| Secondary |
Brief Rating Inventory of Executive Functioning - 2nd edition (BRIEF-2): Global Executive Functioning Score |
The Brief Rating Inventory of Executive Functioning - 2nd edition (BRIEF-2) is a standardized rating scale that measures domains of executive functioning, including behavior regulation (inhibition, self-monitoring), emotional regulation (shifting, emotional control), and cognitive regulation (initiation, working memory, plan/organize, task monitoring, and organization of materials). It is made up of 63 items with three answer options (1 = Never; 2= Sometimes; 3=Often). Each item on the parent form is scored 1-3 (1 = Never; 2 = Sometimes; 3 = Often), yielding a raw score of the global scale range from 63 to 189. T scores (M = 50, SD = 10) are used to interpret the level of executive functioning. T-score range is 0-100, and higher scores are indicative of more severe deficiency - 65 or higher is considered to be in the "clinically significant" range. |
Baseline to Week 12 |
|
| Secondary |
Brief Rating Inventory of Executive Functioning - 2nd edition (BRIEF-2): ADHD score |
The Brief Rating Inventory of Executive Functioning - 2nd edition (BRIEF-2) is a standardized rating scale that measures domains of executive functioning, including behavior regulation (inhibition, self-monitoring), emotional regulation (shifting, emotional control), and cognitive regulation (initiation, working memory, plan/organize, task monitoring, and organization of materials). It is made up of 63 items with three answer options (1 = Never; 2= Sometimes; 3=Often). For the ADHD score, 18 items on the BRIEF-2 that correlate with clinical criteria for a diagnosis of ADHD each receive a score from 1-3 (1 = Never; 2 = Sometimes; 3 = Often). These items are summed and produce a range from 18-54, with higher values indicating more ADHD symptoms. |
Baseline to Week 12 |
|
| Secondary |
Brief Rating Inventory of Executive Functioning - 2nd edition (BRIEF-2): Index scores |
The Brief Rating Inventory of Executive Functioning - 2nd edition (BRIEF-2) is a standardized rating scale that measures domains of executive functioning, including 3 index scores of behavior regulation (inhibition, self-monitoring), emotional regulation (shifting, emotional control), and cognitive regulation (initiation, working memory, plan/organize, task monitoring, and organization of materials). It is made up of 63 items with three answer options (1 = Never; 2= Sometimes; 3=Often). Each item on the parent form is scored 1-3 (1 = Never; 2 = Sometimes; 3 = Often), yielding a raw score of the global scale range from 63 to 189. T scores (M = 50, SD = 10) are used to interpret the level of executive functioning. T-score range is 0-100, and higher scores are indicative of more severe deficiency - 65 or higher is considered to be in the "clinically significant" range. |
Baseline to Week 12 |
|
| Secondary |
Sleep Clinical Global Impressions - Severity Scale (Sleep CGI-S) |
The Sleep Clinical Global Impressions - Severity Scale (Sleep CGI-S) is a clinician completed measure based upon interview which assesses severity in domains of ability to fall asleep and remain sleeping independently, bedtime resistance; sleep onset delay; night awakening; caregiver satisfaction with their child's current sleep patterns; family functioning, as affected by their child's current sleep patterns. A 7-point Likert scale is used for each domain with scores ranging from "no concerns"/"does not occur" (1) to "Among the worst" (7). |
Baseline to Week 12 |
|
| Secondary |
Sleep Clinical Global Impressions - Improvement Scale (Sleep CGI-I) |
The Sleep Clinical Global Impressions - Improvement Scale (Sleep CGI-I) is a clinician completed measure based upon interview which assesses improvement in domains of ability to fall asleep and remain sleeping independently, bedtime resistance; sleep onset delay; night awakening; caregiver satisfaction with their child's current sleep patterns; family functioning, as affected by their child's current sleep patterns. A 7-point Likert scale is used for each domain with scores ranging from "very much improved" (1) to "very much worse" (7). |
Baseline to Week 12 |
|
| Secondary |
Autism Family Experience Questionnaire (AFEQ) |
The Autism Family Experience Questionnaire (AFEQ) is a 48-item questionnaire that measures family quality of life with domains of experience of being a parent (range 13 - 65), family live (range 9 - 45), child development and social relationships (range 14 - 70), and child's feelings and behavior (range 12 - 60). The sum of all domains gives the total score (range 48 - 240). Each question is assessed using a 5-point Likert scale. Scores range from "always" (1) to "never" (5)". For the total score and the domain scores a higher score indicates a lower outcome. |
Baseline to Week 12 |
|
| Secondary |
NIH Toolbox Scales: Satisfaction with Social Roles and Activities - Short Form 4a |
National Institutes of Health Patient Reported Outcome Measures Information System (NIH PROMIS) will be used to quantify psychological wellbeing and quality of life through self-report and/or parent proxy report. Satisfaction with Social Roles and Activities - Short Form 4a assesses satisfaction with performing one's usual social roles and activities and uses a 5-point Likert scale with scores ranging from "not at all" (1) to "very much" (5). The sum of all scores yields a total raw score (range 4 - 20) with higher scores indicating a greater level of satisfaction. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. |
Baseline to Week 12 |
|
| Secondary |
NIH Toolbox Scales: Life Satisfaction - Short Form 8b |
National Institutes of Health Patient Reported Outcome Measures Information System (NIH PROMIS) will be used to quantify psychological wellbeing and quality of life through self-report and/or parent proxy report. Life Satisfaction - Short Form 8b assesses an individual's cognitive evaluation of life experiences and whether one likes his/her life or not. Each question is scored using a 5-point Likert scale with scores ranging from "not at all" (1) to "very much" (5). The sum of all scores yields a total raw score (range 8 - 40) with higher scores indicating a greater level of satisfaction. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. |
Baseline to Week 12 |
|
| Secondary |
NIH Toolbox Scales: Positive Affect - Short Form 4a |
National Institutes of Health Patient Reported Outcome Measures Information System (NIH PROMIS) will be used to quantify psychological wellbeing and quality of life through self-report and/or parent proxy report. Positive Affect - Short Form 41 assesses momentary positive or rewarding affective experiences, such as feelings and mood associated with pleasure, joy, happiness, and excitement. Each question is scored using a 5-point Likert scale with scores ranging from "not at all" (1) to "very much" (5). The sum of all scores yields a total raw score (range 4 - 20) with higher scores indicating a greater level of positive affect. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. |
Baseline to Week 12 |
|
| Secondary |
Pediatric Quality of Life Inventory (PedsQL) - Core Scale |
The Pediatric Quality of Life Inventory (PedsQL) - Core Scale is a 23-item caregiver questionnaire to evaluate overall quality of life (QOL) in domains of physical functioning, emotional functioning, social functioning, and school functioning. A 5-point Likert scale is used with responses ranging from "Never" (0) to "Almost Always" (4). Items are reversed scored and transformed to a 0 - 100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. The total score is the sum of all the items over the number of items answered with higher scores indicating better health-related quality of life (HRQoL). |
Baseline to Week 12 |
|
| Secondary |
Pediatric Quality of Life Inventory (PedsQL) - Cognitive Functioning Scale |
The Pediatric Quality of Life Inventory (PedsQL) - Cognitive Scale is a 6-item caregiver questionnaire to evaluate an individual's mental abilities including learning, thinking, remembering and attention . A 5-point Likert scale is used with responses ranging from "Never" (0) to "Almost Always" (4). Items are reversed scored and transformed to a 0 - 100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. The total score is the sum of all the items over the number of items answered with higher scores indicating lower problems. |
Baseline to Week 12 |
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