Early Neurodivergent Developmental Trajectories in Autism and in Response to the ESDM Intervention

Primary outcomes

1. The Autism Diagnostic Observation Schedule-Second Edition (ADOS-2)

   Time frame: The test will be scheduled pre intervention (T0) after six months (T2) and at the study conclusion, 1 year (T4). The complete test takes 90 minutes.

   The Autism Diagnostic Observation Schedule-Second Edition (ADOS-2) is the "gold standard" for the assessment of autism spectrum disorder. It is an activity-based assessment evaluating communication skills, social interaction and imaginative use of materials through five modules:

   • Toddler Module: for children from 12 to 30 months who have not yet developed fluent language. It provides a risk indicator.
   • Module 1: for children from 31 months without fluent language. Autism Spectrum: total score ≥ 12 Autism: total score ≥ 16
   • Module 2: for children who produce complete sentences even if not fully fluent, even under 30 months.

   Autism Spectrum: total score ≥ 8 Autism: total score ≥ 12

   • Module 3: for children and young adolescents with fluent verbal language. Autism Spectrum: total score ≥ 7 Autism: total score ≥ 10
   • Module 4: for late adolescents and adults with fluent verbal language. Autism Spectrum: total score ≥ 7 Autism: total score ≥ 10

2. Griffith Scale Development Scales (GMDS)

   Time frame: The test will be scheduled pre intervention (T0), after three months (T1), after six months (T2), after nine months (T3) and at the study conclusion, 1 year (T4). The complete test takes 90 minutes.

   The Griffith Mental Development Scales (GMDS-ER) assess the developmental quotient of infants and young children from birth to eight years in five developmental areas (Griffith, 2006):

   • Locomotor (gross motor skills including balance, coordination and control movements);
   • Personal Social (personal independence and social development);
   • Hearing and Language (receptive and expressive languages);
   • Eye and Hand Coordination (fine motor skills, manual dexterity and visual monitoring skills);
   • Performance (visuospatial skills, speed of working and precision). Subscale quotients are calculated by dividing the developmental age corresponding to each subscale by the actual chronological age and multiplying by 100.The General Quotient (GQ) and each subscale quotient have a mean of 100 points (Standard Deviation (SD) = 15 points).The GQ raw score is the sum of the subscales raw scores. A GQ or a subscale quotient <70 points (>2SD below the mean) indicates developmental delay.

3. Vineland Adaptive Behavior Scales (VABS)

   Time frame: The test will be scheduled pre intervention (T0), after three months (T1), after six months (T2), after nine months (T3) and at the study conclusion, 1 year (T4). The complete test takes 60 minutes.

   The Vineland Adaptive Behavior Scales (VABS) is a standardized assessment tool and measure adaptive behavior (Sparrow et al., 2005). It uses standard scores, percentile ranks and v-scale scores to evaluate an individual's performance across different domains: Communication, Daily Living Skills, Socialization, Motor Skills (optional), and Maladaptive Behavior (optional).

   The key metrics include:

   • Adaptive Behavior Composite (ABC): It is a composite of the domain scores linked to general adaptive functioning.
   • Domain Scores: The domains are: Communication, Daily Living Skills, Socialization, and optionally, Motor Skills and Maladaptive Behavior.
   • Subdomain Scores: These subdomain provide more detailed information within each domain.

   The scores are norm-referenced, meaning they compare an individual's performance to a representative sample of the population, with an average (mean) score of 100 and a standard deviation of 15 for the ABC and domain scores.

4. Early Start Denver Model Curriculum

   Time frame: The test will be scheduled pre intervention (T0), after three months (T1), after six months (T2), after nine months (T3) and at the study conclusion, 1 year (T4). The complete curriculum takes 90 minutes.

   The Early Start Denver Model Curriculum Checklist for Young Children with Autism is used to provide a comprehensive assessment of the skills of toddlers and preschoolers with autism spectrum disorder across a range of developmental domains and to set individualized instructional goals. Administered every 12 weeks, it is an essential tool in the intervention program outlined in Early Start Denver Model for Young Children with Autism manual.