Effectiveness of DIR/Floortime™ in Children With Intellectual Developmental Disorder (DIR-IDD)
Effectiveness of DIR/Floortime™ in Children With Intellectual Developmental Disorder: A Randomized Controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Punjab Province
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Gujranwala, Punjab Province, Pakistán
- SEND Therapy Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: DIR/Floortime + Standard Therapy
Participants receive Integrated DIR/Floortime™ in addition to their routine standard therapeutic services for 10 weeks.
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Integrated Developmental, Individual-differences, Relationship-based (DIR)/Floortime™ intervention delivered for 10 weeks in addition to standard therapy
|
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Comparador activo: Standard Therapy
Participants continue to receive routine standard therapeutic services without the addition of DIR/Floortime™ for 10 weeks.
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Routine therapeutic services provided without DIR/Floortime™ during the 10-week study period.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Socialization Skills
Periodo de tiempo: 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.
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Baseline and Week 10
|
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Communication Skills
Periodo de tiempo: 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.
|
Baseline and Week 10
|
|
Daily Living Skills
Periodo de tiempo: 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.
|
Baseline and Week 10
|
|
Functional Emotional Development
Periodo de tiempo: Baseline and Week 10
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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
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Desordenes mentales
- Manifestaciones neuroconductuales
- Trastornos del neurodesarrollo
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Discapacidad intelectual
- Administración de Servicios de Salud
- Calidad, acceso y evaluación de la atención médica
- Calidad de la atención médica
- Indicadores de calidad, atención médica
- Estándar de cuidado
Otros números de identificación del estudio
- GIFT/PSY/MS/2025/001B
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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