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Enrolling by invitation NCT07426328

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

No phase Interventional Development Language Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nao assisted therapy, Standard therapeutic protocol.
Who it may be relevant to
Registry conditions: Development Language Disorder. Basic parameters: 4 years — 5 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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.

Interventions

  • Behavioral Nao assisted therapy
    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.
  • Behavioral Standard therapeutic protocol
    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 outcome measures

  • Language Development Level Test (TVL) [Time frame: T0(baseline)-T1(6months)]
  • The Child Behavior Checklist (CBCL) [Time frame: T0(baseline)-T1(6months)]
  • Conners' Parent Rating Scale Long Form [Time frame: T0(baseline)-T1(6 months)]
  • Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P) [Time frame: T0(baseline)-T1(6 months)]
  • Motivation Requests During Sessions [Time frame: Each therapy session over 24 weeks (48 sessions total)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Italy · 1 center
  • IRCCS Neurolesi Bonino Pulejo, Messina, — Messina

Publications

  • Garon NM, Piccinin C, Smith IM. Does the BRIEF-P Predict Specific Executive Function Components in Preschoolers? Appl Neuropsychol Child. 2016;5(2):110-8. doi: 10.1080/21622965.2014.1002923. Epub 2015 Apr 29. PMID 25923441
  • Isquith PK, Gioia GA, Espy KA. Executive function in preschool children: examination through everyday behavior. Dev Neuropsychol. 2004;26(1):403-22. doi: 10.1207/s15326942dn2601_3. PMID 15276902
  • Shriberg LD, Tomblin JB, McSweeny JL. Prevalence of speech delay in 6-year-old children and comorbidity with language impairment. J Speech Lang Hear Res. 1999 Dec;42(6):1461-81. doi: 10.1044/jslhr.4206.1461. PMID 10599627
  • Norbury CF, Gooch D, Wray C, Baird G, Charman T, Simonoff E, Vamvakas G, Pickles A. The impact of nonverbal ability on prevalence and clinical presentation of language disorder: evidence from a population study. J Child Psychol Psychiatry. 2016 Nov;57(11):1247-1257. doi: 10.1111/jcpp.12573. Epub 2016 May 16. PMID 27184709
  • Calder SD, Brennan-Jones CG, Robinson M, Whitehouse A, Hill E. The prevalence of and potential risk factors for Developmental Language Disorder at 10 years in the Raine Study. J Paediatr Child Health. 2022 Nov;58(11):2044-2050. doi: 10.1111/jpc.16149. Epub 2022 Aug 3. PMID 35922883
  • Bishop DV. Genes, cognition, and communication: insights from neurodevelopmental disorders. Ann N Y Acad Sci. 2009 Mar;1156(1):1-18. doi: 10.1111/j.1749-6632.2009.04419.x. PMID 19338500
  • L.B. Leonard Children with Specific Language Impairment MIT Press, (2014)

Identifiers

NCT: NCT07426328 · Nao02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗