NCT07426276

Evaluating the Effect of Combined Parent Training Plus Speech Therapy on Children With Speech Development Disorder.

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: IRCCS Centro Neurolesi Bonino Pulejo · Academic / Other
• Sex: All
• Age: 3 Years – 5 Years
• Healthy volunteers: Not accepted

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). 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.

Conditions

• Developmental Language Disorder (DLD)

Interventions

Type	Name	Description
BEHAVIORAL	Assisted speech therapy intervention + parent training	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
BEHAVIORAL	standard speech therapy	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.

Timeline

• Start date: 2025-01-10
• Primary completion: 2026-06-25
• Completion: 2026-07-25
• First posted: 2026-02-23
• Last updated: 2026-02-23

Locations

1 site across 1 country: Italy