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Autism Spectrum DisorderNCT06494605

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

A study testing Early Start Denver Model (ESDM) in people with Autism Spectrum Disorder, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 36 months
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Early Start Denver Model (ESDM)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteItaly
Study dates
1 Nov 2021to 31 May 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 36 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 9Show fewer
  • history of intraventricular hemorrhage
  • known exposure to neurotoxins (including alcohol, drugs)
  • non-Italian-speaking parents

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Liliana Ruta contact

3387638295

liliana.ruta@irib.cnr.it

Cristina Carrozza contact

3462241627

cristina.carrozza@irib.cnr.it

Italy1 site, 1 recruiting

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

    Messina, ME, 98164

    Maria Valeria Maiorana, mariavaleria.maiorana@irib.cnr.it

    Liliana Ruta

    Recruiting

Other trials in Italy

About this study

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

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.

Being tested
Early Start Denver Model (ESDM)
Keywords
autism, early support, children, ESDM, individual trajectories
Medical subject headings
Autism Spectrum Disorder, Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early Start Denver Model (ESDM)Behavioural

    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.

Study groups in NCT06494605
Study groupRoleWhat they receive
Experimental studyExperimentalThe 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
Receives: Behavioral: Early Start Denver Model (ESDM)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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

    Measured: 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.

  2. Griffith Scale Development Scales (GMDS)

    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.

    Measured: 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.

  3. Vineland Adaptive Behavior Scales (VABS)

    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:

    1. Adaptive Behavior Composite (ABC): It is a composite of the domain scores linked to general adaptive functioning.
    2. Domain Scores: The domains are: Communication, Daily Living Skills, Socialization, and optionally, Motor Skills and Maladaptive Behavior.
    3. 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.

    Measured: 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.

  4. Early Start Denver Model Curriculum

    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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2024
  2. Study start1 Nov 2021
  3. Primary completion30 Sep 2024
  4. Study completion31 May 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06494605
Sponsor's protocol ID
CNR-IRIB-PRO-2024-010
Status last verified
Apr 2025
First submitted
2 Jul 2024
Last updated
1 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Ruta L, Leonardi E, Carrozza C, Fama FI, Campisi A, Aiello S; NEST Team; Marino F, Ruggieri A, Baieli S, Mangiapane D, Vivona G, Marciante S, Cusimano G, Narzisi A, Muratori F, Gagliano A, Colombi C, Tartarisco G, Mastrogiuseppe M, Rogers SJ, Lombardo MV, Pioggia G. Early developmental trajectories associated with different styles and intensities of ESDM-based community intervention. J Neurodev Disord. 2026 May 29;18(1):46. doi: 10.1186/s11689-026-09698-w.

    PubMed 42210093

Questions about this trial

What is this clinical trial studying?

A study testing Early Start Denver Model (ESDM) in people with Autism Spectrum Disorder, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Liliana Ruta (3387638295, liliana.ruta@irib.cnr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06494605, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.

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