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Can playful therapy unlock social skills in autism?

NCT ID NCT07758465

Disease control Sponsor: Fatima Tabassum 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This study tests whether adding DIR/Floortime—a child-led, relationship-based therapy—to standard care helps children aged 4-12 with mild-to-moderate autism improve emotional, social, communication, and daily living skills. Half the children receive the 10-week Floortime program plus their usual therapies, while the other half continues with standard care alone. Researchers measure changes using the Functional Emotional Assessment Scale and the Vineland Adaptive Behavior Scales to see if the integrated approach makes a meaningful difference.

What this could mean

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

Active substance
DIR/Floortime, a child-led, relationship-based behavioral intervention
What this could lead to
If effective, this approach could offer a practical way to boost social, communication, and daily living skills in children with autism when added to standard care.
What could go wrong
The trial is small (14 children) and early, so results may not apply broadly. Benefits may be modest, and the intervention requires time and commitment from families.

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

14 people

The number who actually took part.

Started

Feb 2026

Finished

Aug 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

4 to 12 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 4-12 years. * Clinical diagnosis of Autism Spectrum Disorder (ASD) according to DSM-5-TR criteria according to DSM-5-TR criteria. * Mild to moderate ASD severity. * Receiving routine therapeutic services. * Eligible to participate in the 10-week DIR/Floortime™ intervention. * Parent or legal guardian willing to provide written informed consent. Exclusion Criteria: * Severe Autism Spectrum Disorder that would prevent participation in the intervention. * Severe visual, hearing, or physical impairments interfering with assessment or intervention. * Major neurological or genetic disorders that could affect study participation. * Serious medical or psychiatric conditions requiring intensive treatment. * Participation in another intervention study during the study period. * Parent or legal guardian unwilling to provide informed consent.

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder

As listed by the trial registrant

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

Autism spectrum disorder (ASD)

Contacts and locations

Locations

  • SEND Therapy Center

    Gujranwala, Punjab Province, Pakistan

More trials for these conditions

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