Autism Spectrum Disorder Trial, Recruiting NCT03583684 Sponsor: Stanford University Condition: Autism Spectrum Disorder
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Autism Spectrum Disorder Trial, Recruiting

NCT03583684
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:

  • Children who have been diagnosed with Autism Spectrum Disorder (ASD) based on recognised diagnostic tools and interviews
  • Children who are outpatients between 2 years and 4 years 11 months old, of any gender
  • Children at any cognitive (thinking and learning) level, as long as they are able to complete the required assessments well enough to produce valid results
  • Children who have a language delay, as measured by a standard language test — the required level of delay depends on the child's age (confirm with trial site for exact thresholds)
  • Children who have been on the same psychiatric medications or health-based treatments for at least 1 month before the study starts, with no changes planned during the study
  • Children who have been receiving the same therapies, behavioural treatments, and school placement for at least 1 month before the study starts, with no changes expected during the study
  • Children receiving no more than 60 minutes of one-on-one speech therapy per week
  • Children with enough exposure to English that standard English-language tests are appropriate for measuring their progress
  • Children who have at least one parent available who can consistently attend training sessions and take part in related activities
  • Children who have successfully completed a brain scan at the start of the study

Who may not be able to join:

  • Children who have ever been diagnosed with a serious psychiatric condition, such as bipolar disorder
  • Children who have a known genetic condition, such as Fragile X syndrome
  • Children who have an active or unstable medical condition, such as seizures that are not well controlled
  • Children who are currently receiving more than 15 hours per week of one-on-one in-home Applied Behavior Analysis (ABA) therapy
  • Children for whom an MRI scan is not safe — for example, if they have any metal in their body
  • Children who have already had a full course of Pivotal Response Treatment (PRT)

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 22 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: Antonio Hardan, MD, Stanford University

Phone: (650) 736-1235

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
Registry
ClinicalTrials.gov
Start date
7 December 2018
Est. completion
30 November 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Number of Child Utterances During a Structured Lab Observation (SLO)

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: 22 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