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Can playful therapy unlock new skills in children with intellectual disability?

NCT ID NCT07758452

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This trial tests whether adding DIR/Floortime™—a play-based, relationship-focused therapy—to standard care can improve emotional development and everyday skills in children aged 4-12 with mild to moderate intellectual developmental disorder. Over 10 weeks, some children receive the therapy plus usual services, while others receive only standard care. Researchers will measure changes in communication, socialization, daily living skills, and emotional growth to see if this approach offers extra benefits.

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 relationship-based behavioral therapy, added to standard care for 10 weeks
What this could lead to
If effective, this could offer a practical, non-drug way to boost communication, socialization, and daily living skills in children with mild to moderate intellectual developmental disorder.
What could go wrong
This is a small, early-stage trial with only 24 children, so results may not apply broadly. The therapy requires active participation and may not work for every child.

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

24 people

The number who actually took part.

Started

Mar 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 Intellectual Developmental Disorder (IDD) according to DSM-5-TR criteria. * Mild to moderate intellectual developmental impairment. * Receiving routine therapeutic services. * Able to participate in the 10-week DIR/Floortime™ intervention and study assessments. * Written informed consent obtained from a parent or legal guardian. Exclusion Criteria: * Profound or severe Intellectual Developmental Disorder preventing meaningful participation in the intervention. * Severe visual, hearing, or physical impairments that would interfere with assessments 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 written informed consent.

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Conditions

The condition(s) this trial relates to.

intellectual developmental disorder 61 intellectual disability

As listed by the trial registrant

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

Intellectual developmental disorder

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.