- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07426328
Promoting Motivation and Linguage in Developmental Language Disorder Through Interaction With the Humanoid Social Robot
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Messina
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Messina, Messina, Italy, 98124
- IRCCS Neurolesi Bonino Pulejo, Messina,
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: NAO-Assisted Therapy
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).
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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.
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Active Comparator: Standard Speech Therapy
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).
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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T0(baseline)-T1(6months)
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The Child Behavior Checklist (CBCL)
Time Frame: T0(baseline)-T1(6months)
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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.
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T0(baseline)-T1(6months)
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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).
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T0(baseline)-T1(6 months)
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Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)
Time Frame: T0(baseline)-T1(6 months)
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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)
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Motivation Requests During Sessions
Time Frame: Each therapy session over 24 weeks (48 sessions total)
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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
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Each therapy session over 24 weeks (48 sessions total)
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Collaborators and Investigators
Investigators
- Principal Investigator: Cucinotta Francesca, CF, IRCCS Centro Neurolesi Bonino Pulejo
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
- D.V.M. Bishop Genes, cognition, and communication: Insights from neurodevelopmental disorders Ann. N. Y Acad. Sci., 1156 (2009), pp. 1-18,
- L.B. Leonard Children with Specific Language Impairment MIT Press, (2014)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Nao02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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