Phase 3 Autism Spectrum Disorder Trial, Recruiting NCT05268796 Sponsor: Stanford University Condition: Autism Spectrum Disorder
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Phase 3 Autism Spectrum Disorder Trial, Recruiting

NCT05268796
Recruiting Phase 3

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 is between 2 years and 7 years 11 months old
  • The child has an official diagnosis of autism spectrum disorder (ASD)
  • The child shows at least one type of self-harming or aggressive behavior that happens daily or hourly, as measured by a specific behavior checklist
  • The family lives in one of these specific counties in New Mexico or Texas: Bernalillo, Santa Fe, Valencia, Sandoval, Torrance, Socorro, Cibola, Los Alamos, El Paso, Hudspeth, Otero, McKinley, San Miguel, Eddy, Chaves, or Dona Ana
  • The caregiver (parent or guardian) is comfortable speaking and reading in English
  • The caregiver is at least 21 years old
  • The same caregiver can regularly be available at home with their child for one hour per week, over 12 weeks, between 9am and 7pm Monday through Friday
  • The caregiver is willing to have a clinician visit their home for one hour per week for 12 weeks and follow the study's plan
  • The family lives in an area with reliable cell phone signal

Who may not be able to join:

  • The caregiver is already receiving applied behavior analysis (ABA) therapy or parent coaching specifically to help manage their child's difficult behaviors
  • The child engages in behaviors that could cause serious physical harm to themselves or others, such as biting through skin, eye gouging, or breaking bones, where medical treatment may be needed
  • The child has a physical or sensory condition that would prevent them from taking part, such as epilepsy, vision or hearing impairment, or a diagnosed genetic condition such as Fragile X syndrome
  • The caregiver has physical or other limitations that would prevent them from responding to their child's challenging behaviors
  • The child has an underlying health condition that would be better treated with medical care rather than this type of study
  • The child's only qualifying behavior is eating non-food items (pica), even if it happens daily or hourly
  • The caregiver already has another child taking part in this study

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 23 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 650-498-4799

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
Phase 3
Registry
ClinicalTrials.gov
Start date
5 January 2024
Est. completion
1 June 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Frequency of challenging behavior; Parenting Stress Index

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: 23 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