NCT06494605 Early Neurodivergent Developmental Trajectories in Autism and in Response to the ESDM Intervention
| NCT ID | NCT06494605 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto per la Ricerca e l'Innovazione Biomedica |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 33 participants |
| Start Date | 2021-11-01 |
| Primary Completion | 2024-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 33 participants in total. It began in 2021-11-01 with a primary completion date of 2024-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Liliana Ruta
PRINCIPAL INVESTIGATOR
National Research Council of Italy, Institute for Biomedical Research and Innovation (CNR-IRIB)
Frequently Asked Questions
Who can join the NCT06494605 clinical trial?
This trial is open to participants of all sexes, aged 18 Months or older, up to 36 Months, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06494605 currently recruiting?
Yes, NCT06494605 is actively recruiting participants. Contact the research team at liliana.ruta@irib.cnr.it for enrollment information.
Where is the NCT06494605 trial being conducted?
This trial is being conducted at Messina, Italy.
Who is sponsoring the NCT06494605 clinical trial?
NCT06494605 is sponsored by Istituto per la Ricerca e l'Innovazione Biomedica. The principal investigator is Liliana Ruta at National Research Council of Italy, Institute for Biomedical Research and Innovation (CNR-IRIB). The trial plans to enroll 33 participants.