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Completed
NCT07758452
Effectiveness of DIR/Floortime™ in Children With Intellectual Developmental Disorder
Conditions: Intellectual Developmental Disorder
Sex: All
Ages: 4 Years – 12 Years
Healthy volunteers: No
Phase: NA
Enrollment: 24
Sponsor: GIFT University
Location: SEND Therapy Center Gujranwala Punjab Province
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).
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07758452). StuddyBuddy aggregates publicly available trial information.