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Enrolling by Invitation

NCT Number: NCT07426328

Promoting Motivation and Linguage in Developmental Language Disorder Through Interaction With the Humanoid Social Robot

Developmental Language Disorder (DLD) is a communication disorder that interferes with learning, understanding, and using language. This pilot study investigates the use of the humanoid robot NAO as part of a rehabilitative program designed for children with DLD. NAO, with its predictable and engaging interaction style, is hypothesized to enhance communicative initiative, expressive communication, and social interaction in this population. The study employs a randomized controlled trial design, assigning participants to either a NAO-assisted intervention group or a control group receiving standard therapy. Outcomes will be assessed using standardized measures of communication, motivation, and observational data. This research aims to explore the potential of social robots as an innovative tool for addressing the unique needs of individuals with DLD, contributing to the development of effective, accessible therapeutic options that improve their quality of life and that of their families.

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Key information

Conditions

Development Language Disorder Communication Disorders Language Development Disorders Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

4 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Neurolesi Bonino Pulejo, Messina,

Messina, 98124, Italy

About this study

Developmental Language Disorder (DLD) is a communication disorder that interferes with learning, understanding, and using language. DLD is a neurodevelopmental disorder caused by complex interactions between genes and the environment that affect brain development. The exact causes of the brain differences that lead to DLD are unknown. Like other neurodevelopmental disorders, DLD often shows familial aggregation. Children with DLD are more likely than their typically developing peers to have first-degree relatives-such as parents and siblings-who have experienced language-related difficulties or delays. In fact, it is estimated that 5-7% of the population is affected by DLD, and many children with DLD have at least one family member with the disorder. In addition, other potentially related neurodevelopmental disorders, such as dyslexia or autism, are more common among the family members of children with DLD.

Early diagnosis and tailored therapeutic interventions are crucial for improving long-term outcomes in this population. However, conventional therapies often face limitations, including variability in efficacy and difficulty maintaining engagement among children with DLD. In recent years, the integration of advanced technologies into therapeutic programs has gained traction as an innovative approach to address communication challenges in neurodevelopmental disorders. Social robots, such as the humanoid robot NAO, offer unique opportunities to engage children with DLD through consistent and predictable interactions. NAO is equipped with capabilities including speech recognition, gestures, and responses to touch and movement, making it a promising tool for promoting communication and social behaviors. Preliminary studies suggest that social robots can enhance engagement and improve social skills in children, yet their potential remains underexplored in Developmental Language Disorder. This single-blind, randomized controlled study aims to evaluate the feasibility and effectiveness of a rehabilitative treatment program integrating the NAO robot for children with DLD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Developmental language disorder
  • Age between 4 and 5 years.

Exclusion criteria

  • Presence of severe intellectual disability.
  • Diagnosis of neurological disorders.
  • Significant medical conditions that could interfere with study participation.

Treatment and study plan

Nao assisted therapy

Behavioral

The sessions included tasks designed to engage children in verbal and social interactions (e.g., naming objects, responding to questions, performing gestures). The NAO robot provided consistent and predictable feedback, while therapists supported and reinforced appropriate communicative behaviors.

Standard therapeutic protocol

Behavioral

The therapy included exercises aimed at improving verbal communication and social engagement (e.g., naming objects, sentence construction, and comprehension tasks). Therapists adjusted the intervention to match each child's communication goals.

Primary outcomes

  1. Language Development Level Test (TVL)

    Time frame: T0(baseline)-T1(6months)

    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.

  2. The Child Behavior Checklist (CBCL)

    Time frame: T0(baseline)-T1(6months)

    The Child Behavior Checklist (CBCL) is a caregiver-reported questionnaire used to identify emotional and behavioral problems in children. It measures multiple domains, including emotional reactivity, anxiety, attention problems, and social difficulties. The T-scores do not have a specific range, but values between 50 and 70 are considered within the normal range, while 70 to 100 indicates clinical significance. Higher scores indicate greater behavioral problems.

  3. Conners' Parent Rating Scale Long Form

    Time frame: T0(baseline)-T1(6 months)

    The Conners' Parent Rating Scale - Revised: Long Form (CPRS-R:L) is a standardized parent-report questionnaire used to assess Attention Deficit/Hyperactivity Disorder (ADHD) symptoms and other behavioral problems in children aged 6 to 18 years. The scale includes 80 items, each rated from 0 (Not True at All) to 3 (Very Much True). Subscale scores and a total score are derived. Total scores typically range from 0 to 240, with higher scores indicating more severe behavioral and attentional problems (i.e., a worse outcome).

  4. Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)

    Time frame: T0(baseline)-T1(6 months)

    The Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P) is a standardized parent-report questionnaire used to assess executive function behaviors in children aged 2 to 5 years. The scale consists of 63 items, each rated on a 3-point Likert scale (Never = 1, Sometimes = 2, Often = 3). Raw scores are converted to T-scores, which typically range from 30 to 90.

    Higher T-scores indicate greater executive function difficulties (i.e., a worse outcome). T-scores above 65 are considered clinically elevated.

  5. Motivation Requests During Sessions

    Time frame: Each therapy session over 24 weeks (48 sessions total)

    This observational measure tracks and records the number of spontaneous and prompted requests initiated by the child to express needs or desires during therapy sessions. Frequency count per session. Higher frequencies indicate greater communicative initiative

Sponsors and collaborators

Lead sponsor

IRCCS Centro Neurolesi Bonino Pulejo

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

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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