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Can intensive behavioral therapy boost social skills in young children with autism?

NCT ID NCT03778827

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether an intensive, center-based version of Pivotal Response Treatment (PRT) can improve social communication in preschoolers with autism. 75 children aged 2 to 4 years participated. The therapy combined weekly parent training with center-based sessions for a total of 13 hours per week. Researchers measured changes in social responsiveness, communication, and adaptive behaviors after 12 weeks.

What this could mean

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

Active substance
Pivotal Response Treatment (PRT) – a behavioral therapy
What this could lead to
If it works, this could provide an effective early intervention to improve social communication skills in young children with autism.
What could go wrong
This is a small, completed trial with 75 children. Results may not apply to all children with autism, and behavioral therapies require significant time and commitment.

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

75 people

The number who actually took part.

Started

May 2019

Finished

Mar 2026

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 3 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 Autism Spectrum Disorder (ASD) based on clinical interview and Diagnostic and Statistical Manual, 5th edition (DSM-5) and confirmed using the Autism Diagnostic Interview Revised (ADI-R) and Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2) or Childhood Autism Rating Scale (CARS-2); Diagnostic and Statistical Manual, 5th edition (DSM-5), and expert clinical opinion * Boys and girls between 2 years and 3 years and 11 months * Ability to participate in the testing procedures to the extent that valid standard scores can be obtained * Stable treatment (e.g., applied behavior analysis (ABA), speech therapy, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation * Developmentally delayed with Mullen Scales of Early Learning (MSEL) or Developmental Profile (DP-4) composite score below 85 (1 Standard Deviation below the mean) * Availability of at least one English-speaking parent who can consistently participate in parent training and research measures. Exclusion Criteria: * Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.) * Presence of active medical problem (e.g., unstable seizure disorder or heart disease) * Child primary language other than English * Previous adequate trial of Pivotal Response Treatment * More than 15 hours per week of in-home applied behavior analysis (ABA).

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Conditions

The condition(s) this trial relates to.

autism autism spectrum disorder

As listed by the trial registrant

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

Autism Autism spectrum disorder

Contacts and locations

Locations

  • Stanford University School of Medicine

    Stanford, California, 94305, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.