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Completed

NCT Number: NCT07758452

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

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).

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Key information

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SEND Therapy Center

Gujranwala, Punjab Province, Pakistan

About this study

Intellectual Developmental Disorder (IDD) is characterized by significant limitations in intellectual functioning and adaptive behavior, affecting conceptual, social, and practical skills. Although conventional therapeutic interventions support developmental progress, many children continue to experience challenges in communication, social interaction, daily living skills, and functional emotional development. The Developmental, Individual-differences, Relationship-based (DIR)/Floortime™ model is a relationship-based intervention designed to enhance emotional, social, and developmental capacities through child-led interactions.

This study is a parallel-group randomized controlled trial evaluating the effectiveness of Integrated DIR/Floortime™ in children with IDD. Participants aged 4-12 years will be randomly assigned to either an experimental group receiving DIR/Floortime™ in addition to standard therapy or a control group receiving standard therapy alone. The intervention will be delivered over a period of 10 weeks.

The primary outcomes include communication, socialization, daily living skills, and functional emotional development. These outcomes will be measured using the Vineland Adaptive Behavior Scales (VABS) and the Functional Emotional Assessment Scale (FEAS) at baseline and after completion of the 10-week intervention. The findings will contribute to the evidence regarding the effectiveness of DIR/Floortime™ for children with Intellectual Developmental Disorder.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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. Exclusion Criteria 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.

Treatment and study plan

DIR/Floortime™

Behavioral

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

Standard Therapy

Behavioral

Routine therapeutic services provided without DIR/Floortime™ during the 10-week study period.

Primary outcomes

  1. Communication Skills

    Time frame: Baseline and Week 10

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

  2. Socialization Skills

    Time frame: Baseline and Week 10

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

  3. Daily Living Skills

    Time frame: Baseline and Week 10

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

  4. Functional Emotional Development

    Time frame: Baseline and Week 10

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

Sponsors and collaborators

Lead sponsor

GIFT University

Other

Registry information

Official study title

Effectiveness of DIR/Floortime™ in Children With Intellectual Developmental Disorder: A Randomized Controlled Trial

Acronym: DIR-IDD

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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