Clinical trial NCT06494605: Early Neurodivergent Developmental Trajectories in Autism and in Response to the ESDM Intervention
Official title: Early Neurodivergent Developmental Trajectories in Toddlers and Young Children on the Autism Spectrum and Effectiveness of the Early Start Denver Model in Community Settings
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: autism
early support
children
ESDM
individual trajectories
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
Collaborators: name: Istituto Superiore di Sanità
name: Messina, Italy
name: Società Cooperativa Sociale AUDACIA
name: Associazione Ulisse
name: La Linea Curva
First posted: 2024-07-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Early support is thought to be key to ensure a better quality of life for young children on the autism spectrum. Among early support, different evidence-based approaches have combined the principles of developmental and behavioral science within a naturalistic and interactive frame and grouped under the umbrella of Naturalistic Developmental Behavioral Interventions (NDBI). In the context of NDBIs, the Early Start Denver Model is a manualized support that has reported evidence of efficacy for therapist-, group- and caregiver-implemented support, in multiple research as well as community based settings, different countries and languages (Rogers \& Dawson, 2010). Understanding the effects of support characteristics and intensity on individual learning has a major impact on the delivery systems organization and policies, sustainability in low resources community settings and to provide the necessary support to the family. However, a direct comparison among different types and intensity of early support in community setting and relatively low access to standardized and intensive programs, have not been adequately explored. For this reason, the aim of this study is to investigate, in a community setting in the Italian context, the impact of ESDM and support intensity on individual developmental trajectories.


Eligibility criteria: Inclusion Criteria:

* unimpaired hand use
* parent agreement to have a caregiver present during all home sessions
* attendance at all intake sessions
* permission to videotape evaluations and ESDM treatment
* Italian as one primary language of the parent
* unimpaired hearing and vision
* developmental quotient of 35 or higher on the Griffith Scale
* meets all of these autism spectrum disorder diagnostic criteria through the Autism Diagnostic Observation Schedule (ADOS; cutoff score of 12 if child produces no words or 10 if child produces some words)

Exclusion Criteria:

* serious parental substance abuse
* parental self-report of bipolar disorder or psychosis
* known genetic syndromes
* serious medical conditions (e.g., encephalitis, concussion, seizure disorder)
* significant sensory impairment
* birth weight \<1600 grams and/or gestational age \< 34 weeks
* history of intraventricular hemorrhage
* known exposure to neurotoxins (including alcohol, drugs)
* non-Italian-speaking parents

Primary outcomes:
measure: The Autism Diagnostic Observation Schedule-Second Edition (ADOS-2)
timeFrame: 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.
measure: Griffith Scale Development Scales (GMDS)
timeFrame: 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.
measure: Vineland Adaptive Behavior Scales (VABS)
timeFrame: 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.
measure: Early Start Denver Model Curriculum
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: Institute for Biomedical Research and Innovation (IRIB)-National Reasearch Council (CNR),
state: ME
Study officials:
affiliation: National Research Council of Italy, Institute for Biomedical Research and Innovation (CNR-IRIB)
name: Liliana Ruta
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bruschetta, R., Campisi, S., Mastrogiuseppe, M., Leonardi, E., Aiello, S., Salvatore, C., ... & Tartarisco, G. (2023, July). A deep learning approach for automatic video coding of deictic gestures in children with autism. In 2023 3rd International Conference on Electrical, Computer, Communications and Mechatronics Engineering (ICECCME) (pp. 1-6). IEEE.
citation: Campisi, A., Mastrogiuseppe, M., Aiello, S., Leonardi, E. L. I. S. A., Fama, F. I., Carrozza, C., ... & Ruta, L. (2023). Early Language-Specific Developmental Differences in Young Children with and without Autism. INSAR 2023.
citation: Mastrogiuseppe, M., Leonardi, E. L. I. S. A., Aiello, S., Fama, F. I., Campisi, A., Carrozza, C., ... & Ruta, L. (2023). Characteristics of Gesture Communication in Young Children with Autism during Naturalistic Play Interactions. INSAR 2023.
citation: Fama, F. I., Aiello, S., Carrozza, C., Leonardi, E. L. I. S. A., Campisi, A., Blandino, C., ... & Ruta, L. (2023). Parental Interaction Style during Naturalistic Play Activities in Young Children with and without Autism. INSAR 2023.
citation: Ruta, L., Mastrogiuseppe, M., Fama, F. I., Carrozza, C., Leonardi, E. L. I. S. A., Aiello, S., ... & Pioggia, G. (2023). Early Developmental Trajectories in Response to Early Start Denver Model: Effects of Treatment Type and Intensity in Community Settings. INSAR 2023.