Evaluating the Effect of Combined Parent Training Plus Speech Therapy on Children With Speech Development Disorder. (DLD25!!)

February 16, 2026 updated by: IRCCS Centro Neurolesi Bonino Pulejo

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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Messina
      • Messina, Messina, Italy, 98124
        • IRCCS Neurolesi Bonino Pulejo, Messina,, Messina, Messina 98124

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of 'Developmental Language Disorders' (DLD)
  • Age between 3 and 5 years.
  • Signature of informed consent by parents and/or legal guardians.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Assisted speech therapy intervention + parent training

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 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
Active Comparator: Standard Speech Therapy

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
T0(baseline)-T1(6months)
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.
T0 (baseline)- T1 (6months)
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).
T0(baseline)-T1(6 months)
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
T0(baseline)-T1(6 months)
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.
T0(baseline)-T1(6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Centro Neurolesi Bonino Pulejo

Investigators

  • Principal Investigator: Cucinotta Francesca, CF, IRCCS Centro Neurolesi Bonino Pulejo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2025

Primary Completion (Estimated)

June 25, 2026

Study Completion (Estimated)

July 25, 2026

Study Registration Dates

First Submitted

February 16, 2026

First Submitted That Met QC Criteria

February 16, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DLD25

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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