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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07758465
Acronym
DIR-ASD
Enrollment
14
Registered
2026-08-11
Start date
2026-02-15
Completion date
2026-08-04
Last updated
2026-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder (ASD

Keywords

DIR Floortime, Developmental Individual-differences Relationship-based Model, VABS, FEAS, Autism Spectrum disorder

Brief 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.

Detailed description

Autism Spectrum Disorder (ASD) is a neurodevelopmental condition that significantly affect emotional development, communication, and social interaction. Although conventional interventions target specific developmental domains, many children continue to experience challenges in functional emotional capacities and daily living skills. Developmental, Individual-differences, Relationship-based (DIR)/Floortime™ is a relationship-based intervention that promotes emotional regulation, communication, social engagement, and higher-order thinking through child-led, developmentally appropriate interactions. This study investigates the effectiveness of integrating DIR/Floortime™ with standard therapeutic services. This study uses a parallel-group randomized controlled design. Eligible children aged 4-12 years diagnosed with ASD are randomly assigned to either an intervention group receiving DIR/Floortime™ plus standard therapies or a control group receiving standard therapies alone. Outcomes are measured before and after the intervention using the Functional Emotional Assessment Scale (FEAS) and the Vineland Adaptive Behavior Scales (VABS). The findings are expected to contribute evidence regarding the effectiveness of DIR/Floortime™ in improving functional emotional development and adaptive behavior among children with ASD and IDD.

Interventions

BEHAVIORALDIR/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.

BEHAVIORALStandard therapy

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

Sponsors

Fatima Tabassum
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Participants were randomly assigned to either an intervention group receiving DIR/Floortime™ in addition to standard therapies or a control group receiving standard therapies alone. Both groups were followed concurrently and assessed at baseline and post-intervention.

Eligibility

Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Socialization SkillsBaseline and Week 10Change in Socialization Skills measured using the Vineland Adaptive Behavior Scales, Third Edition (VABS-3), Socialization domain Growth Scale Values (GSVs). GSVs range from 10 to 197, with higher scores indicating better adaptive functioning.
Communication SkillsBaseline and Week 10Change in Communication Skills measured using the Vineland Adaptive Behavior Scales, Third Edition (VABS-3), Communication domain Growth Scale Values (GSVs). GSVs range from 10 to 197, with higher scores indicating better adaptive functioning.
Daily Living SkillsBaseline and Week 10Change in Daily Living Skills measured using the Vineland Adaptive Behavior Scales, Third Edition (VABS-3), Daily Living Skills domain Growth Scale Values (GSVs). GSVs range from 10 to 197, with higher scores indicating better adaptive functioning.
Functional Emotional DevelopmentBaseline and Week 10Change in functional emotional development measured using the Functional Emotional Assessment Scale (FEAS). FEAS items are scored from 0 to 2, with higher scores indicating better functional emotional development. Symbolic, Sensory, and Examiner scores are assessed.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 14, 2026