Autism Spectrum Disorder Trial, Recruiting NCT06494605 Sponsor: Istituto per la Ricerca e l'Innovazione Biomedica Condition: Autism Spectrum Disorder
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Autism Spectrum Disorder Trial, Recruiting

NCT06494605
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • The child has full use of their hands without impairment
  • A parent or caregiver agrees to be present during all home sessions
  • The family is able to attend all intake (initial assessment) sessions
  • The family gives permission for evaluations and therapy sessions to be recorded on video
  • At least one parent speaks Italian as a primary language
  • The child has unimpaired hearing and vision
  • The child scores 35 or higher on a developmental assessment called the Griffith Scale, which measures general development
  • The child meets the diagnostic criteria for autism spectrum disorder based on a standardised assessment tool called the ADOS, with a score of 12 or above if the child uses no words, or 10 or above if the child uses some words

Who may not be able to join:

  • A parent has a serious problem with alcohol or drug misuse
  • A parent has self-reported a diagnosis of bipolar disorder or psychosis
  • The child has a known genetic syndrome
  • The child has a serious medical condition, such as brain inflammation, concussion, or a seizure disorder
  • The child has a significant problem with hearing or vision
  • The child was born weighing less than 1,600 grams or was born before 34 weeks of pregnancy
  • The child has a history of bleeding inside the brain (intraventricular hemorrhage)
  • The child is known to have been exposed to substances that can harm the brain and nervous system, including alcohol or drugs
  • The parents do not speak Italian

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Liliana Ruta, National Research Council of Italy, Institute for Biomedical Research and Innovation (CNR-IRIB)

Phone: 3387638295

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Istituto per la Ricerca e l'Innovazione Biomedica
Registry
ClinicalTrials.gov
Start date
1 November 2021
Est. completion
30 September 2024

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

The Autism Diagnostic Observation Schedule-Second Edition (ADOS-2); Griffith Scale Development Scales (GMDS); Vineland Adaptive Behavior Scales (VABS); Early Start Denver Model Curriculum

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov