Virtual Reality-supported Language Intervention for Preschool Children With DLD

N/AEnrolling By InvitationNCT07438639

IRCCS Centro Neurolesi Bonino Pulejo100 enrolled

Overview

This study aims to test the effectiveness of virtual reality-supported speech therapy in improving basic language skills in children aged 3 to 6 years diagnosed with Developmental Language Disorder (DLD). Participants are randomly assigned to either traditional speech therapy or virtual reality-supported therapy, with the same frequency and duration of intervention. Language outcomes are assessed before and after treatment using the Language development level test (TVL), a standardized assessment of Italian for preschoolers. The study adopts a randomized controlled design with individualized, goal-oriented therapy delivered by certified speech-language pathologists.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Language Development Disorders

Interventions

The VRRS delivers personalized language therapy exercises via touchscreen interface. Activities target receptive language, repetition, naming, and spontaneous language production. All sessions are conducted by trained speech-language pathologists in accordance with standardized therapeutic protocols.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 8 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 3 and 6 years at enrollment * Clinical diagnosis of Developmental Language Disorder (DLD) based on DSM-5 and standardized language assessments * Developmental Quotient (DQ) \> 70 on the Griffiths III Scales * Good general health without neurological or psychiatric comorbidities * Informed consent signed by a parent or legal guardian Exclusion Criteria: * Age not between 3 and 6 years * Lack of clinical diagnosis of Developmental Language Disorder (DLD) * Developmental Quotient (DQ) \< 70 on the Griffiths Scale III * Presence of neurological or psychiatric comorbidities * Lack of signed informed consent from a parent or legal guardian

Outcomes

Primary Outcomes

Language Development Level Test (TVL)

The Test of Verbalization and Language Development is a standardized tool designed to assess various aspects of language development, including verbal production, comprehension, sentence construction, phonological accuracy, and morphosyntactic abilities. The weighted score ranges from 0 to 10, with higher scores indicating better language development.

Time frame: Baseline and Month 3

Secondary Outcomes

Griffiths III Scales

General cognitive development will be assessed using the Griffiths III Scales of Child Development. The Global Developmental Quotient, DQ, has a possible range from 50 to 150, with higher scores indicating better developmental and cognitive functioning. The DQ will be used as an index of overall cognitive functioning and as a potential moderator in the analysis of language outcomes.

Time frame: Baseline