An interventional study of Assisted speech therapy intervention + parent training and standard speech therapy in Developmental Language Disorder (DLD), sponsored by IRCCS Centro Neurolesi Bonino Pulejo. Enrolling by invitation at 1 site in Italy. Open to participants aged 3 Years to 5 Years. Per ClinicalTrials.gov, last updated 2026-02-23.
Sponsored by IRCCS Centro Neurolesi Bonino Pulejo · Not applicable, Interventional, and Treatment
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.
121 studies on the registry are indexed under Language Development Disorders; 49 are open to participants now.
This study's planned enrollment of 100 is above the median of 74 across 106 interventional studies indexed under Language Development Disorders.
Browse Language Development Disorders studies →IRCCS Centro Neurolesi Bonino Pulejo is the lead sponsor of 67 studies on the registry; 31 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Behavioral: Assisted speech therapy intervention + parent training
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.
Behavioral: standard speech therapy
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
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.
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.
Time frame: 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.
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: T0(baseline)-T1(6 months)
Started Jan 2025 (actual). Primary completion is estimated for Jun 2026, 17 months after the start.
Of 72 non-industry interventional studies with no phase under Language Development Disorders, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 57. This study's planned 17 months is below that.
Counting every sponsor, half of 72 studies reached it within 30 months; a quarter within 19 and three quarters within 57.
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IRCCS Centro Neurolesi Bonino Pulejo