NCT07758465Completed
Effectiveness of DIR/Floortime™ in Children With Autism Spectrum Disorder
Efficacy of Integrated DIR/Floortime™ for Children With Autism Spectrum Disorder: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
This randomized controlled trial evaluates the efficacy of Integrated DIR/Floortime™ in improving functional emotional development and adaptive behavior in children aged 4-12 years with Autism Spectrum Disorder (ASD). Participants are randomly assigned to either an intervention group receiving DIR/Floortime™ in addition to their ongoing standard therapies or a control group receiving standard therapies alone. Functional emotional development is assessed using the Functional Emotional Assessment Scale (FEAS), while adaptive behavior is evaluated using the Vineland Adaptive Behavior Scales (VABS). The study aims to determine whether integrating DIR/Floortime™ leads to greater improvements in emotional, social, communication, and adaptive functioning compared with standard interventions alone.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 6 Aug 2026
- Start date
- 15 Feb 2026
- Primary completion date
- 20 Jul 2026
- Lead sponsor
- Fatima Tabassum
- Diseases
- Autism
- NCT number
- NCT07758465
What you commit to
- Study type: Interventional
- Participants enrolled: 14
- From 15 Feb 2026 to the primary completion date, 20 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe Autism Spectrum Disorder that would prevent participation in the intervention.
- Major neurological or genetic disorders that could affect study participation.
- Serious medical or psychiatric conditions requiring intensive treatment.
Other
- Severe visual, hearing, or physical impairments interfering with assessment or intervention.
- Participation in another intervention study during the study period.
- Parent or legal guardian unwilling to provide informed consent.
Who the study is looking for
- 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.
Age in the registry: 4 years to 12 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SEND Therapy Center Coordinator of this site? Confirm its status | Gujranwala | Pakistan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.