Last reviewed · How we verify
NCT05614206
Biomarkers Trajectories of Early Intervention in Siblings of Children with Autism Spectrum Disorder
NA trial testing Behavioral intervention based on Applied Behavior Analysis principles in Autism Spectrum Disorder in 80 participants. Completed in 26 September 2024.
26 September 2023
Quick facts
| Lead sponsor | IRCCS Eugenio Medea |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 80 |
| Start date | 26 September 2022 |
| Primary completion | 26 September 2023 |
| Estimated completion | 26 September 2024 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Behavioral intervention based on Applied Behavior Analysis principles
Conditions studied
- Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →
- Early Intervention — all drugs for Early Intervention →
Sponsor
IRCCS Eugenio Medea — full company profile →
Who can join
Adults 18 Months to 24 Months, any sex, with Autism Spectrum Disorder or Early Intervention. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This project deals with essential challenges in the context of Autism Spectrum Disorder benefiting from a prospective design in childhood, early intervention and a cutting-edge experimental techniques. The present study tests the potential effect of early intervention on neural and behavioral responses in toddlers at elevated likelihood of developing autism (siblings of children with autism) who show clinical autistic signs. Four comparison groups were included in the study: (1) toddlers at elevated likelihood of developing autism with clinical autistic signs who receive early intervention from 18 to 24 months (2) toddlers at elevated likelihood of developing autism with clinical autistic signs who do not receive early intervention (3) toddlers at elevated likelihood of developing autism without clinical autistic signs who only received assessment and monitoring, and (4) typically developing toddlers who only received assessment and monitoring. This study focuses on social and nonsocial sensory integration skills (measured by electroencephalographic and eyetracking recordings) to identify reliable biomarkers for early detection and intervention of autism during a critical period of development. The characterization of biomarkers will guide the detection of the most vulnerable children that will benefit from early intervention, with the long-term aim of reducing the impact of autism on the National Health System.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05614206
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Autism Spectrum Disorder
Currently open trials in the same condition.
- NCT07324057 — The Effects of Preoperative Intranasal Administration of Dexmedetomidine and Esketamine on Negative Postoperative Behavi · NA · recruiting
- NCT07493096 — Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disor · recruiting
- NCT07505290 — Efficacy of the Korean PEERS® for Preschoolers (PEERS®-PS-K) Social Skills Intervention: A Randomized Controlled Trial f · NA · active not recruiting
- NCT07524192 — A Self-Instructional Online Program for Early Childhood and Elementary Teachers Supporting Autistic Children and Childre · NA · recruiting
- NCT07432776 — Effect of an 8-Week Pickleball Program for Adults With Autism: A Feasibility Trial With a Delayed-Control Design · EARLY_PHASE1 · recruiting
Other IRCCS Eugenio Medea trials
Trials by the same sponsor.
- NCT07095062 — Electroencephalogram in Patients With Friedreich's Ataxia for the Study of the Structural and Functional Connectome. · NA · recruiting
- NCT06993389 — AI-based Model for Rehabilitation Engagement and Motor Performance Evaluation in Pediatric Patients · recruiting
- NCT06999850 — Implementation and Validation of Instrumented Stair Climb Test · NA · recruiting
- NCT06666777 — Speech Therapy and Parenting for Early Socio-communicAtive sKills · NA · recruiting
- NCT07470138 — Sleep Disturbance in Subjects With Autism Spectrum Disorders (ASD) in Preschool Age (18-60 Months) · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05614206 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by IRCCS Eugenio Medea
- Last refreshed: 14 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05614206.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing