Home play therapy shows promise for autism social skills

NCT ID NCT07708246

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This study tests a parent-led, home-based play program designed to improve social cognitive skills—like recognizing emotions and understanding others' perspectives—in young children with autism. Parents are trained to deliver daily 30-minute cooperative games for six months, with monthly video feedback from a clinician. Researchers measure changes in social attention using eye-tracking and theory-of-mind tasks, comparing children in the program to those receiving usual care.

What this could mean

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

Active substance
a parent-mediated, home-based structured play program called the Companion Mind-Drawing Cooperative Game Program
What this could lead to
If it works, this could offer families a low-cost, home-based way to boost social skills like understanding others' thoughts and emotions in young children with autism.
What could go wrong
This is a small, non-randomized study, so results may not apply to all children. The program requires daily parent effort for six months, and improvements may be modest or hard to measure.

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 60 people

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

Started

Jun 2025

Expected to finish

Dec 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

4 to 8 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: * Aged 2.5 to 14 years at time of enrollment, with a primary recruitment focus on children aged 3 to 10 years. * Meets diagnostic criteria for autism spectrum disorder (ASD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by a specialist clinician. * Full-scale intelligence quotient (FSIQ) ≥ 70 as assessed by an age-appropriate Wechsler intelligence scale administered. * Possesses sufficient verbal ability to engage with structured play-based intervention activities, as judged by the recruiting clinician. * Resides with and is cared for by a participating parent or legal guardian who meets the caregiver eligibility criteria below. Caregiver: * Is the primary caregiver (parent or legal guardian) of the enrolled child and resides in the same household. * Is able and willing to attend an in-person parent training session (approximately 2.5 hours) at the study site prior to intervention commencement. * Is able and willing to commit to administering the structured intervention program to the child for a minimum of 30 minutes per day throughout the 6-month intervention period. * Is able and willing to participate in monthly online video supervision sessions with the study clinician. * Has sufficient literacy and comprehension ability to understand program training materials and follow intervention procedures. * Provides written informed consent on behalf of the child and for their own participation prior to any study procedures. Exclusion Criteria: Children: * Known diagnosis of a genetic syndrome associated with ASD or intellectual disability, including but not limited to Fragile X syndrome, Down syndrome, tuberous sclerosis complex, or Rett syndrome. * Presence of a neurological disorder, including epilepsy (unless fully controlled with stable medication for ≥ 12 months), acquired brain injury, cerebral palsy, or other significant neurological condition that may confound assessment of social cognition. * Uncorrected vision or hearing impairment that would preclude participation in behavioral or eye-tracking assessments. * Currently enrolled in another interventional clinical study targeting social cognition, communication, or behavioral outcomes. * Any medical, psychiatric, or developmental condition that, in the opinion of the recruiting clinician, would interfere with the child's ability to participate in or benefit from the intervention. Caregiver: * Unable to attend the in-person parent training session at the study site due to geographic, occupational, or other constraints. * Unable to commit to the daily home-based intervention schedule or monthly online supervision sessions for the full 6-month intervention period. * Presence of significant mental health difficulties or other circumstances that, in the opinion of the recruiting clinician, would substantially impair the caregiver's ability to deliver the intervention with adequate fidelity.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Children's Hospital of Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 201102, China

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