Developmental Language Disorder (DLD)DLD25!!NCT07426276
Evaluating the Effect of Combined Parent Training Plus Speech Therapy on Children With Speech Development Disorder.
A study testing Assisted speech therapy intervention + parent training and standard speech therapy in people with Developmental Language Disorder (DLD), run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
Trial summary
Language is an extremely complex cognitive function that, in situations of typical development, i.e. in the absence of deficits or environmental risk, is generally acquired with apparent ease and naturalness (Kuhl, 2010). Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Developmental Language Disorder (DLD)
- What is being tested?
- Assisted speech therapy intervention + parent training and standard speech therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2025to 25 Jul 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 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of 'Developmental Language Disorders' (DLD)
- Age between 3 and 5 years.
- Signature of informed consent by parents and/or legal guardians.
Who cannot join
- No sensory impairment or another medical or neurological condition (ADHD, Autism, Deafness, Mental Retardation <70);
- Significant medical conditions that could interfere with participation in the study.
- Failure to sign informed consent by parents and/or legal guardians.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS Neurolesi Bonino Pulejo, Messina,, Messina, Messina 98124
Messina, Messina, 98124
About this study
Language is an extremely complex cognitive function that, in situations of typical development, i.e. in the absence of deficits or environmental risk, is generally acquired with apparent ease and naturalness (Kuhl, 2010).
The first 1,000 days of life are considered a key time window in which children's developmental trajectories and future outcomes are shaped. During this period, it is crucial to provide children with nurturing experiences such as responsive care and appropriate learning opportunities (Britto et al., 2017).
Read more
Most children learn communication skills (e.g., pointing, gesturing) and language skills (e.g., saying words, following instructions) from high-quality interactions with parents and caregivers. However, some children may have language learning difficulties for a variety of reasons, including genetic, neurological and environmental.
Not all children necessarily follow the stages outlined: some present delayed language development. The early identification and diagnosis of the language disorder is therefore very important as this deficit can have a negative impact on the child's subsequent development of skills, the way he/she relates and subsequent acquisition skills in primary school.
This research aims to assess whether parents, guided and monitored by the speech therapist and psychologist through parental training, can try out specific and effective strategies that enable them to become a facilitating model for the child's communicative-linguistic learning, thereby also improving their quality of life.
- Conditions
- Developmental Language Disorder (DLD)
- Being tested
- Assisted speech therapy intervention + parent training, standard speech therapy
- 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.
Assisted speech therapy intervention + parent trainingBehavioural
The intervention was tailored to individual needs and aimed at improving verbal expression, communicative initiative, and social engagement. Each child receives therapy for a period of 16 weeks, for a total of 32 sessions, twice a week, with each session lasting 45 minutes and in addition 16 sessions of parent traning once a week for 45 minutes.Intervention sessions included tasks designed to engage the child in verbal and social interactions, (such as naming objects, answering questions and performing gestures) to improve verbal expression communicative intention and social engagement, in parallel the parents once a week participate in a parent training session with the aim of supporting and directing them to learn strategies to improve interaction with the child and facilitate communicative-linguistic development
standard speech therapyBehavioural
Therapy followed established protocols and was adapted to meet the specific needs of the children. Each child received therapy for a period of 16 weeks (twice a week), for a total of 32 sessions.• Standard therapeutic approaches included exercises to improve verbal communication and social engagement, such as object naming, sentence construction and comprehension tasks. Therapists adapted the intervention to the individual communication goals of each 45-minute session.
| Study group | Role | What they receive |
|---|---|---|
| Assisted speech therapy intervention + parent training | Experimental | The treatment group consists of 20 children diagnosed with DLD (Language Development Disorder).
The participants were randomly assigned and will undergo a structured rehabilitation programme of parent training + speech therapy Receives: Behavioral: Assisted speech therapy intervention + parent training |
| Standard Speech Therapy | Active comparator | The control group consisted of 20 children diagnosed with DLD (Language Development Disorder).
Participants were randomly assigned and were subjected to standard therapy approaches, which included traditional speech therapy provided by qualified therapists. Receives: Behavioral: standard speech therapy |
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)
Questionnaire on Parenting Styles (QSP)
This instrument consists of different forms that consider the three fundamental domains of parent-child interaction: a) the social domain: assessed through 8 items; b) the educational domain: assessed through 7 items; c) the disciplinary domain: assessed through 2 items. In this study, each parent completed four forms of the questionnaire: one assessing what their parental behaviour is like in reality (real style; Form A), one assessing what they would ideally like their own behaviour to be like (ideal style; Form B), one assessing what their partner's parental behaviour is like in reality (real style; Form C) and one assessing what they would ideally like their partner's parental behaviour to be like (ideal style; Form D).
Measured: T0(baseline)-T1(6 months)
WHOQOL
It assesses individuals' perceptions of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, norms and standards.
The WHOQOL-BRIEF is a 26-item self-report instrument that assesses four domains that are assumed to represent the Quality of Life (QOL) construct: the physical domain, the psychological domain, the social relations domain and the environmental domain, plus two aspects for assessing overall QOL and general health.
It provides a multi-dimensional profile of QOL domain and sub-domain scores
Measured: T0(baseline)-T1(6 months)
Il Parenting Stress Index
It defines the level of stress (anxiety, discomfort, maladaptive coping, etc.) that a parent is experiencing in their parental role.
It is closely linked to personal characteristics of the subject that reverberate in the way he or she performs and experiences this role.
The stress components most associated with this subscale are:
a negative experience regarding one's parental competence; stress resulting from the restrictions the parental role places on other social roles important to the subject; conflict with the spouse; lack of social support; and the presence of depression in the clinical sense.
Measured: T0(baseline)-T1(6 months)
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 start10 Jan 2025
- Primary completion25 Jun 2026 (estimated)
- Study completion25 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Developmental Language Disorder (DLD)Studies 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
- 100 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
- NCT07426276
- Sponsor's protocol ID
- DLD25
- Acronym
- DLD25!!
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zwitserlood-Nijenhuis MA, Wiefferink CH, Gerrits E. A randomized study of parent- versus child-directed intervention for Dutch toddlers with DLD. Int J Lang Commun Disord. 2023 Sep-Oct;58(5):1768-1782. doi: 10.1111/1460-6984.12901. Epub 2023 May 29.
PubMed 37248804Hawa VV, Spanoudis G. Toddlers with delayed expressive language: an overview of the characteristics, risk factors and language outcomes. Res Dev Disabil. 2014 Feb;35(2):400-7. doi: 10.1016/j.ridd.2013.10.027. Epub 2013 Dec 14.
PubMed 24334229Collisson BA, Graham SA, Preston JL, Rose MS, McDonald S, Tough S. Risk and Protective Factors for Late Talking: An Epidemiologic Investigation. J Pediatr. 2016 May;172:168-174.e1. doi: 10.1016/j.jpeds.2016.02.020. Epub 2016 Mar 8.
PubMed 26968834Rowe ML. A longitudinal investigation of the role of quantity and quality of child-directed speech in vocabulary development. Child Dev. 2012 Sep-Oct;83(5):1762-74. doi: 10.1111/j.1467-8624.2012.01805.x. Epub 2012 Jun 20.
PubMed 22716950Buschmann A, Jooss B, Rupp A, Dockter S, Blaschtikowitz H, Heggen I, Pietz J. Children with developmental language delay at 24 months of age: results of a diagnostic work-up. Dev Med Child Neurol. 2008 Mar;50(3):223-9. doi: 10.1111/j.1469-8749.2008.02034.x. Epub 2008 Feb 11.
PubMed 18266869Britto PR, Lye SJ, Proulx K, Yousafzai AK, Matthews SG, Vaivada T, Perez-Escamilla R, Rao N, Ip P, Fernald LCH, MacMillan H, Hanson M, Wachs TD, Yao H, Yoshikawa H, Cerezo A, Leckman JF, Bhutta ZA; Early Childhood Development Interventions Review Group, for the Lancet Early Childhood Development Series Steering Committee. Nurturing care: promoting early childhood development. Lancet. 2017 Jan 7;389(10064):91-102. doi: 10.1016/S0140-6736(16)31390-3. Epub 2016 Oct 4.
PubMed 27717615
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
- Evaluating the Effect of Combined Parent Training Plus Speech Therapy on Children With Speech Development Disorder.
- ClinicalTrials.gov ID
- NCT07426276
- Acronym / sponsor ID
- DLD25!! / DLD25
- Conditions
- Developmental Language Disorder (DLD)
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 25 Jun 2026 (estimated)
- Study completion
- 25 Jul 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.
Language is an extremely complex cognitive function that, in situations of typical development, i.e. in the absence of deficits or environmental risk, is generally acquired with apparent ease and naturalness (Kuhl, 2010).
The first 1,000 days of life are considered a key time window in which children's developmental trajectories and future outcomes are shaped. During this period, it is crucial to provide children with nurturing experiences such as responsive care and appropriate learning opportunities (Britto et al., 2017).
Most children learn communication skills (e.g., pointing, gesturing) and language skills (e.g., saying words, following instructions) from high-quality interactions with parents and caregivers. However, some children may have language learning difficulties for a variety of reasons, including genetic, neurological and environmental.
Not all children necessarily follow the stages outlined: some present delayed language development. The early identification and diagnosis of the language disorder is therefore very important as this deficit can have a negative impact on the child's subsequent development of skills, the way he/she relates and subsequent acquisition skills in primary school.
This research aims to assess whether parents, guided and monitored by the speech therapist and psychologist through parental training, can try out specific and effective strategies that enable them to become a facilitating model for the child's communicative-linguistic learning, thereby also improving their quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assisted speech therapy intervention + parent training | Experimental | Behavioral: Assisted speech therapy intervention + parent trainingThe treatment group consists of 20 children diagnosed with DLD (Language Development Disorder). The participants were randomly assigned and will undergo a structured rehabilitation programme of parent training + speech therapy |
| Standard Speech Therapy | Active comparator | Behavioral: standard speech therapyThe control group consisted of 20 children diagnosed with DLD (Language Development Disorder). Participants were randomly assigned and were subjected to standard therapy approaches, which included traditional speech therapy provided by qualified therapists. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosis of 'Developmental Language Disorders' (DLD)
- Age between 3 and 5 years.
- Signature of informed consent by parents and/or legal guardians.
Key exclusion criteria (3 listed)
- No sensory impairment or another medical or neurological condition (ADHD, Autism, Deafness, Mental Retardation <70);
- Significant medical conditions that could interfere with participation in the study.
- Failure to sign informed consent by parents and/or legal guardians.
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 |
|---|---|---|
| Assisted speech therapy intervention + parent trainingThe intervention was tailored to individual needs and aimed at improving verbal expression, communicative initiative, and social engagement. Each child receives therapy for a period of 16 weeks, for a total of 32 sessions, twice a week, with each session lasting 45 minutes and in addition 16 sessions of parent traning once a week for 45 minutes.Intervention sessions included tasks designed to engage the child in verbal and social interactions, (such as naming objects, answering questions and performing gestures) to improve verbal expression communicative intention and social engagement, in parallel the parents once a week participate in a parent training session with the aim of supporting and directing them to learn strategies to improve interaction with the child and facilitate communicative-linguistic development | Behavioural | Assisted speech therapy intervention + parent training |
| standard speech therapyTherapy followed established protocols and was adapted to meet the specific needs of the children. Each child received therapy for a period of 16 weeks (twice a week), for a total of 32 sessions.• Standard therapeutic approaches included exercises to improve verbal communication and social engagement, such as object naming, sentence construction and comprehension tasks. Therapists adapted the intervention to the individual communication goals of each 45-minute session. | 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.
Questionnaire on Parenting Styles (QSP)
Time frame: T0(baseline)-T1(6 months)
This instrument consists of different forms that consider the three fundamental domains of parent-child interaction: a) the social domain: assessed through 8 items; b) the educational domain: assessed through 7 items; c) the disciplinary domain: assessed through 2 items. In this study, each parent completed four forms of the questionnaire: one assessing what their parental behaviour is like in reality (real style; Form A), one assessing what they would ideally like their own behaviour to be like (ideal style; Form B), one assessing what their partner's parental behaviour is like in reality (real style; Form C) and one assessing what they would ideally like their partner's parental behaviour to be like (ideal style; Form D).
WHOQOL
Time frame: T0(baseline)-T1(6 months)
It assesses individuals' perceptions of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, norms and standards. The WHOQOL-BRIEF is a 26-item self-report instrument that assesses four domains that are assumed to represent the Quality of Life (QOL) construct: the physical domain, the psychological domain, the social relations domain and the environmental domain, plus two aspects for assessing overall QOL and general health. It provides a multi-dimensional profile of QOL domain and sub-domain scores
Il Parenting Stress Index
Time frame: T0(baseline)-T1(6 months)
It defines the level of stress (anxiety, discomfort, maladaptive coping, etc.) that a parent is experiencing in their parental role. It is closely linked to personal characteristics of the subject that reverberate in the way he or she performs and experiences this role. The stress components most associated with this subscale are: a negative experience regarding one's parental competence; stress resulting from the restrictions the parental role places on other social roles important to the subject; conflict with the spouse; lack of social support; and the presence of depression in the clinical sense.
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 37248804Zwitserlood-Nijenhuis MA, Wiefferink CH, Gerrits E. A randomized study of parent- versus child-directed intervention for Dutch toddlers with DLD. Int J Lang Commun Disord. 2023 Sep-Oct;58(5):1768-1782. doi: 10.1111/1460-6984.12901. Epub 2023 May 29.
- Results publication: PubMed 24334229Hawa VV, Spanoudis G. Toddlers with delayed expressive language: an overview of the characteristics, risk factors and language outcomes. Res Dev Disabil. 2014 Feb;35(2):400-7. doi: 10.1016/j.ridd.2013.10.027. Epub 2013 Dec 14.
- Results publication: PubMed 26968834Collisson BA, Graham SA, Preston JL, Rose MS, McDonald S, Tough S. Risk and Protective Factors for Late Talking: An Epidemiologic Investigation. J Pediatr. 2016 May;172:168-174.e1. doi: 10.1016/j.jpeds.2016.02.020. Epub 2016 Mar 8.
- Results publication: PubMed 22716950Rowe ML. A longitudinal investigation of the role of quantity and quality of child-directed speech in vocabulary development. Child Dev. 2012 Sep-Oct;83(5):1762-74. doi: 10.1111/j.1467-8624.2012.01805.x. Epub 2012 Jun 20.
- Results publication: PubMed 18266869Buschmann A, Jooss B, Rupp A, Dockter S, Blaschtikowitz H, Heggen I, Pietz J. Children with developmental language delay at 24 months of age: results of a diagnostic work-up. Dev Med Child Neurol. 2008 Mar;50(3):223-9. doi: 10.1111/j.1469-8749.2008.02034.x. Epub 2008 Feb 11.
- Results publication: PubMed 27717615Britto PR, Lye SJ, Proulx K, Yousafzai AK, Matthews SG, Vaivada T, Perez-Escamilla R, Rao N, Ip P, Fernald LCH, MacMillan H, Hanson M, Wachs TD, Yao H, Yoshikawa H, Cerezo A, Leckman JF, Bhutta ZA; Early Childhood Development Interventions Review Group, for the Lancet Early Childhood Development Series Steering Committee. Nurturing care: promoting early childhood development. Lancet. 2017 Jan 7;389(10064):91-102. doi: 10.1016/S0140-6736(16)31390-3. Epub 2016 Oct 4.
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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 Assisted speech therapy intervention + parent training and standard speech therapy in people with Developmental Language Disorder (DLD), 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 3 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 NCT07426276, which also lists 6 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.