Effectiveness of DIR/Floortime™ in Children With Autism Spectrum Disorder (NCT07758465) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness of DIR/Floortime™ in Children With Autism Spectrum Disorder
Pakistan14 participantsStarted 2026-02-15
Plain-language summary
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.
Who can participate
Age range
4 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.