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Effectiveness of DIR/Floortime™ in Children With Autism Spectrum Disorder

NCT07758465 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-08-11

No results posted yet for this study

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.

Conditions

  • Autism Spectrum Disorder (ASD

Interventions

BEHAVIORAL

DIR/Floortime

Participants received Integrated DIR/Floortime™ intervention for 10 weeks in addition to their ongoing standard therapies. The intervention focused on promoting functional emotional development, communication, social interaction, and adaptive functioning through child-led, relationship-based sessions conducted according to the DIR/Floortime™ model.

BEHAVIORAL

Standard therapy

Participants continued to receive routine standard therapeutic services without the addition of DIR/Floortime™ during the 10-week study period.

Sponsors & Collaborators

  • GIFT University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-15
Primary Completion
2026-07-20
Completion
2026-08-04

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07758465 on ClinicalTrials.gov