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Can intensive early intervention boost social skills in kids with autism?

NCT ID NCT04026386

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 study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a 12-week early intervention program for preschoolers (ages 2 to 5) with developmental disorders like autism or intellectual disability. The program provides 12 hours of therapy each week, either at a center or at home, aiming to improve social communication. Researchers will measure changes in social skills and repetitive behaviors using parent questionnaires.

What this could mean

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

Active substance
Early intervention program (behavioral therapy)
What this could lead to
If successful, this program could provide a structured approach to improve social communication skills in young children with developmental disorders.
What could go wrong
This is a small, early-stage study with only 75 participants, so results may not apply to all children. The program is intensive and may not be feasible for every family.

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 75 people

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

Started

Oct 2019

Expected to finish

Dec 2034

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 5 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: * Diagnosis of Developmental Disorder, such as Autism Spectrum Disorder, neurogenetic disorder, or intellectual disability, based on clinical interview; * Boys and girls between 2.0 years and 5.11 years at time of enrollment; * Ability to participate in the testing procedures to the extent that valid standard scores can be obtained. Exclusion Criteria: * Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.); * Lack of availability during program hours.

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder developmental disability learning disability

As listed by the trial registrant

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

Autism spectrum disorder Development delay Development disorder, child Developmental disability

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 School of Medicine

    RECRUITING

    Stanford, California, 94305, United States

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