Table 4.
Primary and secondary efficacy outcome measures.
| Domain | Measure | |
|---|---|---|
| Primary efficacy outcome | Neurocognitive Composite | Average working memory (SB-5 working memory), processing speed (CPT-3 mean reaction time) and fine motor (Purdue Pegboard-average of both hands) subtests weighted at 2/3 of the composite score and the average of all other available neurocognitive testing measures (receptive and expressive language, non-verbal ability, verbal learning, sustained attention, impulsivity, and visuomotor skills) weighted at 1/3 of the score. |
| Secondary efficacy outcomes | Global Ability | SB-5: Full scale IQ, Verbal IQ, and Non-Verbal IQ or the Mullen Scales of Learning: Cognitive IQ |
| Attention | CPT-3 (CPT-3/K-CPT-2): Discriminability (d’) and Omissions | |
| Processing Speed | CPT-3 (CPT-3/K-CPT-2): Mean Reaction Time; in cases where an individual cannot complete the CPT, we will administer the appropriate Wechsler processing speed index subtest. | |
| Impulsivity | CPT: Commissions and Bias | |
| Long-Term Memory | WRAML-2 Verbal Learning: Scaled score | |
| Language | Peabody Picture Vocabulary Test −4 (PPVT-4): Standard Score Expressive Vocabulary Test – 2 (EVT-2): Standard Score |
|
| Motor Functioning | Purdue Pegboard (Pegs): Dominant and non-dominant hand standard scores | |
| Motor Coordination | Developmental Coordination Disorder Questionnaire (DCDQ): Total score | |
| Autism Symptoms | Autism Diagnostic Observation Schedule (ADOS): Calibrated severity score | |
| Social Responsiveness Scale – 2 (SRS-2): Total T-score | ||
| Repetitive Behavior Scale – Revised (RBS-R): Total raw score | ||
| Other Behavioral Symptoms | Behavior Rating Inventory of Executive Function (BRIEF) - Global Executive Composite: Standard Score | |
| Child Behavior Checklist - Total Problems: Standard Score | ||
| Sensory Processing | Short Sensory Profile (SSP): Total Score | |
| Adaptive Behavior | Vineland Adaptive Behavior Scales (VABS-III): Composite Standard Score | |
| Global Severity and Improvement | Clinical Global Impressions – Severity (CGI-S) Clinical Global Impressions – Improvement (CGI-I) |
CPT-3: Conners' Continuous Performance Test, Third Edition; SB-5: Stanford-Binet Intelligence Scales, Fifth Edition; WRAML-2: Wide Range Assessment of Memory and Learning, Second Edition.