SEND Therapy Center
Gujranwala, Punjab Province, Pakistan
NCT Number: NCT07758452
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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Notify Me4 year–12 year
All sexes
Interventional
Not applicable
Gujranwala, Punjab Province, Pakistan
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.
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.
Integrated Developmental, Individual-differences, Relationship-based (DIR)/Floortime™ intervention delivered for 10 weeks in addition to standard therapy
Routine therapeutic services provided without DIR/Floortime™ during the 10-week study period.
Time frame: Baseline and Week 10
Change in communication skills measured using the Communication domain of the Vineland Adaptive Behavior Scales (VABS).
Time frame: Baseline and Week 10
Change in socialization skills measured using the Socialization domain of the Vineland Adaptive Behavior Scales (VABS).
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).
Time frame: Baseline and Week 10
Change in functional emotional development measured using the Functional Emotional Assessment Scale (FEAS).
GIFT University
Other
Effectiveness of DIR/Floortime™ in Children With Intellectual Developmental Disorder: A Randomized Controlled Trial
Acronym: DIR-IDD
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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