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Which autism therapy works best? new study aims to find out

NCT ID NCT07522190

Symptom relief Sponsor: Stanford University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 09, 2026 · Updated 3 times

Summary

This study compares two well-known early autism interventions, ESDM and PRT, to see which one helps young children with autism improve their communication skills more. Researchers will enroll 140 children aged 2 to 5 and randomly assign them to one of the two therapies for 24 weeks. The goal is to identify which children benefit most from each approach, potentially leading to more personalized treatment plans.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
behavioral intervention (Early Start Denver Model and Pivotal Response Treatment)
What this could lead to
If successful, this study could help doctors choose the best therapy for each child with autism, improving communication skills more effectively.
What could go wrong
This is an early-stage comparison study, not a treatment trial. Results may not apply to all children, and individual responses can vary widely.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jan 2037

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 4 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Children must be between 2 and 4 years, 11 months of age at enrollment * Confirmed diagnosis of autism spectrum disorder based on standardized diagnostic assessments and clinical judgment * Demonstrated significant language delay as determined by standardized language measures * Ability to participate in study assessments and intervention procedures * At least one English-speaking parent or caregiver available to participate in parent training and research measures * Receiving stable community-based treatments or medications for at least one month prior to baseline, with no anticipated changes during the study period Exclusion Criteria: * Current or lifetime diagnosis of a severe psychiatric disorder (e.g., bipolar disorder) * Presence of an active or unstable medical condition (e.g., uncontrolled seizure disorder or significant cardiac disease) * Child's primary language is not English * Prior adequate trial of PRT or ESDM * Receipt of more than 15 hours per week of in-home applied behavior analysis services * Inability to complete study assessments or procedures to obtain valid data

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Conditions

The condition(s) this trial relates to.

autism autism spectrum disorder Communication Language

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autism Autism spectrum disorder (ASD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Stanford University

    Palo Alto, California, 94305-5719, United States

More trials for these conditions

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