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

NCT07758465 | Completed

• 1 other identifier: GIFT/PSY/MS/2025/001
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder (ASD

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Socialization Skills

  Change in socialization skills measured using the Socialization domain of the Vineland Adaptive Behavior Scales (VABS).

  Baseline and Week 10

• Communication Skills

  Change in communication skills measured using the Communication domain of the Vineland Adaptive Behavior Scales (VABS).

  Baseline and Week 10

• Daily Living Skills

  Change in daily living skills measured using the Daily Living Skills domain of the Vineland Adaptive Behavior Scales (VABS).

  Baseline and Week 10

• Functional Emotional Development

  Change in functional emotional development measured using the Functional Emotional Assessment Scale (FEAS).

  Baseline and Week 10

Study Arms (2)

DIR/Floortime + Standard Therapy

EXPERIMENTAL

Participants received Integrated DIR/Floortime™ in addition to their ongoing standard therapies.

Behavioral: DIR/Floortime

Standard Therapy

ACTIVE COMPARATOR

Participants continued to receive standard therapies without DIR/Floortime

Behavioral: Standard therapy

Interventions

DIR/Floortime BEHAVIORAL

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.

DIR/Floortime + Standard Therapy

Standard therapy BEHAVIORAL

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

Standard Therapy

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GIFT University: lead

Study Sites (1)

SEND Therapy Center

Gujranwala, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fatima Tabassum

Model Details: 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.

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 11, 2026
• Study Start: February 15, 2026
• Primary Completion: July 20, 2026
• Study Completion: August 4, 2026
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)