Effectiveness of DIR/Floortime™ in Children With Intellectual Developmental Disorder

NCT07758452 | Completed

• 1 other identifier: GIFT/PSY/MS/2025/001B
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to evaluate the effectiveness of Integrated Developmental, Individual-differences, Relationship-based (DIR)/Floortime™ intervention in improving functional emotional development and adaptive behavior in children with Intellectual Developmental Disorder (IDD). Participants aged 4-12 years will be randomly assigned to receive either DIR/Floortime™ in addition to standard therapy or standard therapy alone for 10 weeks. Outcomes will be assessed using the Functional Emotional Assessment Scale (FEAS) and the Vineland Adaptive Behavior Scales (VABS).

Conditions

Intellectual Developmental Disorder

Keywords

Intellectual developmental disorder; FEAS; VABS; IDD; DIR/Floortime

Outcome Measures

Primary Outcomes (4)

• Communication Skills

  Change 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.

  Baseline and Week 10

• Socialization Skills

  Change 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.

  Baseline and Week 10

• Daily Living Skills

  Change 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.

  Baseline and Week 10

• Functional Emotional Development

  Change 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.

  Baseline and Week 10

Study Arms (2)

DIR/Floortime + Standard Therapy

EXPERIMENTAL

Participants receive Integrated DIR/Floortime™ in addition to their routine standard therapeutic services for 10 weeks.

Behavioral: DIR/Floortime™

Standard Therapy

ACTIVE COMPARATOR

Participants continue to receive routine standard therapeutic services without the addition of DIR/Floortime™ for 10 weeks.

Behavioral: Standard therapy

Interventions

DIR/Floortime™ BEHAVIORAL

Integrated Developmental, Individual-differences, Relationship-based (DIR)/Floortime™ intervention delivered for 10 weeks in addition to standard therapy

DIR/Floortime + Standard Therapy

Standard therapy BEHAVIORAL

Routine therapeutic services provided without 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 Intellectual Developmental Disorder (IDD) according to DSM-5-TR criteria.
• Mild to moderate intellectual developmental impairment.
• Receiving routine therapeutic services.
• Able to participate in the 10-week DIR/Floortime™ intervention and study assessments.
• Written informed consent obtained from a parent or legal guardian.

You may not qualify if:

• Profound or severe Intellectual Developmental Disorder preventing meaningful participation in the intervention.
• Severe visual, hearing, or physical impairments that would interfere with assessments 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 written informed consent.

Sponsors & Collaborators

• GIFT University: lead

Study Sites (1)

SEND Therapy Center

Gujranwala, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Intellectual Disability

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; 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: Principle investigator

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 11, 2026
• Study Start: March 16, 2026
• Primary Completion: July 15, 2026
• Study Completion: August 1, 2026
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)