Development Language DisorderNCT07426328
Promoting Motivation and Linguage in Developmental Language Disorder Through Interaction With the Humanoid Social Robot
A study testing Nao assisted therapy and Standard therapeutic protocol in people with Development Language Disorder, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 5 years
- Conditions the study is for
- Development Language Disorder
- What is being tested?
- Nao assisted therapy and Standard therapeutic protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2025to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Developmental language disorder
- Age between 4 and 5 years.
Who cannot join
- Presence of severe intellectual disability.
- Diagnosis of neurological disorders.
- Significant medical conditions that could interfere with study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Development Language Disorder
- Being tested
- Nao assisted therapy, Standard therapeutic protocol
- Medical subject headings
- Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nao assisted therapyBehavioural
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 protocolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Behavioral: Standard therapeutic protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: Each therapy session over 24 weeks (48 sessions total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Feb 2025
- Primary completion1 Apr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Development Language DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cucinotta Francesca, CF, Principal investigator, IRCCS Centro Neurolesi Bonino Pulejo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426328
- Sponsor's protocol ID
- Nao02
- Status last verified
- Feb 2026
- First submitted
- 4 Jul 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 25923441Isquith 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.
PubMed 15276902Shriberg 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.
PubMed 10599627Norbury 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.
PubMed 27184709Calder 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.
PubMed 35922883Bishop 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.
PubMed 19338500L.B. Leonard Children with Specific Language Impairment MIT Press, (2014)
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Motivation and Linguage in Developmental Language Disorder Through Interaction With the Humanoid Social Robot
- ClinicalTrials.gov ID
- NCT07426328
- Acronym / sponsor ID
- Nao02
- Conditions
- Development Language Disorder
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAO-Assisted Therapy | Experimental | Behavioral: Nao assisted therapyThis 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). |
| Standard Speech Therapy | Active comparator | Behavioral: Standard therapeutic protocolThis 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). |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Developmental language disorder
- Age between 4 and 5 years.
Key exclusion criteria (3 listed)
- Presence of severe intellectual disability.
- Diagnosis of neurological disorders.
- Significant medical conditions that could interfere with study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nao assisted therapyThe 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. | Behavioural | NAO-Assisted Therapy |
| Standard therapeutic protocolThe 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. | Behavioural | Standard Speech Therapy |
Primary outcome
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.
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.
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).
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Results publication: PubMed 25923441Garon 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.
- Results publication: PubMed 15276902Isquith 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.
- Results publication: PubMed 10599627Shriberg 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.
- Results publication: PubMed 27184709Norbury 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.
- Results publication: PubMed 35922883Calder 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.
- Results publication: PubMed 19338500Bishop 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.
- Results publicationL.B. Leonard Children with Specific Language Impairment MIT Press, (2014)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cucinotta Francesca, CF principal investigator
IRCCS Centro Neurolesi Bonino Pulejo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nao assisted therapy and Standard therapeutic protocol in people with Development Language Disorder, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Language Development Level Test (TVL) (time frame: T0(baseline)-T1(6months)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07426328, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.