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

NCT ID: NCT06494605

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2025-05-31

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.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental study

The experimental group consists of 33 children diagnosed with early signs of neurodivergence or diagnosis of autism. The sample is aged between 18 and 48 months

Group Type: EXPERIMENTAL

Early Start Denver Model (ESDM)

Intervention Type: BEHAVIORAL

The Early Start Denver Model (ESDM) is an early naturalistic and behavioural intervention for children with initial signs of neurodivergence or on the autism spectrum between the ages of 12-48 months. This early intervention aims to increase the rates of development in several domains and to decrease the characteristics of autism conditions that hinder children's ability to learn from everyday experiences and interactions.

Interventions

Early Start Denver Model (ESDM)

The Early Start Denver Model (ESDM) is an early naturalistic and behavioural intervention for children with initial signs of neurodivergence or on the autism spectrum between the ages of 12-48 months. This early intervention aims to increase the rates of development in several domains and to decrease the characteristics of autism conditions that hinder children's ability to learn from everyday experiences and interactions.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Superiore di Sanità

OTHER

Sponsor Role: collaborator

Messina, Italy

OTHER

Sponsor Role: collaborator

Società Cooperativa Sociale AUDACIA

UNKNOWN

Sponsor Role: collaborator

Associazione Ulisse

UNKNOWN

Sponsor Role: collaborator

La Linea Curva

UNKNOWN

Sponsor Role: collaborator

Istituto per la Ricerca e l'Innovazione Biomedica

OTHER

Sponsor Role: lead

Responsible Party

Liliana Ruta

MD, PhD, Head of Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liliana Ruta

Role: PRINCIPAL_INVESTIGATOR

National Research Council of Italy, Institute for Biomedical Research and Innovation (CNR-IRIB)

Locations

Institute for Biomedical Research and Innovation (IRIB)-National Reasearch Council (CNR),

Messina, ME, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Liliana Ruta

Role: CONTACT

liliana.ruta@irib.cnr.it

3387638295

Cristina Carrozza

Role: CONTACT

cristina.carrozza@irib.cnr.it

3462241627

Facility Contacts

Maria Valeria Maiorana

Role: primary

mariavaleria.maiorana@irib.cnr.it

References

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

Other Identifiers

CNR-IRIB-PRO-2024-010

Identifier Type: -

Identifier Source: org_study_id