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

NCT07426328 | Enrolling By Invitation

• 1 other identifier: Nao02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Development Language Disorder

Outcome Measures

Primary Outcomes (5)

• 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.

  T0(baseline)-T1(6months)

• The Child Behavior Checklist (CBCL)

  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.

  T0(baseline)-T1(6months)

• Conners' Parent Rating Scale Long Form

  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).

  T0(baseline)-T1(6 months)

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

  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.

  T0(baseline)-T1(6 months)

• Motivation Requests During Sessions

  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

  Each therapy session over 24 weeks (48 sessions total)

Study Arms (2)

NAO-Assisted Therapy

EXPERIMENTAL

This group includes 50 children diagnosed with Developmental Language Disorder (DLD). Participants were randomly assigned to a structured rehabilitative program integrated with the NAO humanoid robot. The intervention was tailored to individual needs and aimed to improve communicative initiative, verbalization, and social engagement. Each child received therapy over 24 weeks, for a total of 48 sessions (2 per week, 45 minutes each).

Behavioral: Nao assisted therapy

Standard Speech Therapy

ACTIVE COMPARATOR

This group includes 50 children diagnosed with Developmental Language Disorder (DLD). Participants were randomly assigned to receive standard therapeutic approaches, including traditional speech therapy provided by trained therapists. The intervention was adapted to meet the specific needs of minimally verbal children. Each child received therapy over 24 weeks, for a total of 48 sessions (2 per week, 45 minutes each).

Behavioral: Standard therapeutic protocol

Interventions

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.

NAO-Assisted Therapy

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.

Standard Speech Therapy

Eligibility Criteria

• Age: 4 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

IRCCS Neurolesi Bonino Pulejo, Messina,

Messina, Messina, 98124, Italy

Location

Related Publications (7)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• D.V.M. Bishop Genes, cognition, and communication: Insights from neurodevelopmental disorders Ann. N. Y Acad. Sci., 1156 (2009), pp. 1-18,

  RESULT

• L.B. Leonard Children with Specific Language Impairment MIT Press, (2014)

  RESULT

MeSH Terms

Conditions

Language Development Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Cucinotta Francesca, CF

  IRCCS Centro Neurolesi Bonino Pulejo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: February 23, 2026
• Study Start: February 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

IT (1)