Intellectual Developmental Disorder
Conditions
Keywords
Intellectual developmental disorder, FEAS, VABS, IDD, DIR/Floortime
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).
Detailed description
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.
Interventions
BEHAVIORALDIR/Floortime™
Integrated Developmental, Individual-differences, Relationship-based (DIR)/Floortime™ intervention delivered for 10 weeks in addition to standard therapy
BEHAVIORALStandard therapy
Routine therapeutic services provided without DIR/Floortime™ during the 10-week study period.
Sponsors
GIFT University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Communication Skills | Baseline and Week 10 | 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. |
| Socialization Skills | Baseline and Week 10 | 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. |
| Daily Living Skills | Baseline and Week 10 | 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. |
| Functional Emotional Development | Baseline and Week 10 | 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. |
Countries
Pakistan
Outcome results
None listed