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Can Play-Based therapy boost skills in autistic kids? major study launches

NCT ID NCT06005285

Disease control Sponsor: University of California, Davis 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether the Early Start Denver Model (ESDM), a play-based behavioral therapy, helps young autistic children improve language and daily living skills when used in community programs. Researchers will enroll 600 participants, including 300 children aged 1-5, across multiple U.S. sites. The goal is to see if this evidence-based approach works outside of research settings and can benefit more families.

What this could mean

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

Active substance
Early Start Denver Model (ESDM) – a behavioral therapy that uses play and daily activities to teach skills
What this could lead to
If successful, this could show that ESDM works in real-world community settings, improving communication and daily living skills for more autistic children.
What could go wrong
This is an early-stage effectiveness study, not a cure. Results may vary across different programs, and improvements might be modest or not sustained long-term.

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 600 people

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

Started

Mar 2024

Expected to finish

Jun 2028

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

12 months and older

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.

The investigators will collect data from leaders, providers and clients in participating autism CBAs. The investigators will collect data from 20 Regional Managers, 100 supervisors, and 200 technicians working with autistic children. Participants will include 300 children ages 1-5 years with a diagnosis of autism spectrum disorder living in the US and being served by participating treatment team. Inclusion criteria for Autism CBAs include: Serve at least 10 children with autism under age 5 annually and have at least 2 regions that can be randomized. Accept Medicaid or equivalent payment (e.g., funding for low income families through public service systems). Inclusion criteria for supervisors are as follows: 1. employed as a program supervisor at participating region 2. plans to be employed for at least the next 12 months 3. serves children with autism under age 5 4. has not has previous training in ESDM 5. supervises at least two technicians Inclusion criteria for technicians is as follows: 1. supervised by a participating supervisor 2. plans to be employed for at least the next 12 months 3. serves children with autism under age 5 4. has not had previous ESDM training Inclusion criteria for children are as follows: 1. child age 1-5 years 2. has a current autism spectrum disorder (ASD) diagnosis on record or is being served as at-risk for ASD if under age 3 3. family speaks English or Spanish 4. child expected to be in therapy for at least 7 months

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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

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

  • University of California, Davis MIND Institute

    RECRUITING

    Sacramento, California, 95817, United States

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