Speech Therapy and Parenting for Early Socio-communicAtive sKills

Summary

Every year, millions of children are diagnosed with neurodevelopmental disabilities. This term covers a wide range of conditions, from genetic syndromes to brain injuries such as cerebral palsy. Children with neurodevelopmental disabilities often struggle in multiple areas, including language development. While standard speech therapy mainly focuses on understanding and producing words, these children may also have difficulties with the social and communicative skills needed for language. The parent-child relationship is especially important for helping kids develop in their early years.

This clinical trial aims to find out if an intervention focused on early social and communication skills, and involving parents, can help children with neurodevelopmental disabilities. The study includes children aged 6 months to 5 years. It seeks to answer two key questions:

* Does this intervention improve social and communication skills better than standard speech therapy?
* Does this intervention affect how parents interact with their child?

To find the answers, the study will compare two groups: one group will get the parent-involved intervention that focuses on early communication skills, while the other group will get standard speech therapy.

In the first intervention, therapists will guide parents in observing and supporting their child's social and communication behaviors during various activities like playtime and snack time. In contrast, the standard speech therapy will focus on traditional goals, such as improving the child's ability to vocalize, understand, and use words, without involving parents.

Both interventions will follow the same schedule-eight weekly sessions, each lasting 45 minutes, over two months.

Before and after the interventions, the children and parents will:

* Have an assessment of the child's language, social, and communication development.
* Participate in a 10-minute video recording of parent-child playtime, which will be used to study parenting behavior.

Conditions

• Neurological Impairments
• Genetic Syndrome
• Neurodevelopmental Disability
• Developmental Delays
• Language Development Disorders

Interventions

BEHAVIORAL

Intervention focused on intersubjective prelinguistic and socio-communicative skills

The intervention consists of 8 45-minute, weekly sessions over two months. These sessions may take place in various settings, such as free play, snack time, or structured activities. The speech therapist will use these settings to help parents observe intersubjective and social-communicative behaviors, providing guidance and strategies to support them. The following topics will be addressed: Early dyadic interaction; First signals of comprehension; Communicative intentionality; Gestures; Attention; Verbal and motor routine; Lexical and syntactic comprehension; Socio-conversational skills. These topics are not structured into rigid levels for each session. Instead, several topics may be addressed within the same session and revisited across multiple sessions. This flexibility allows the speech therapist to adapt the intervention based on observations, interactions with the child, and discussions with the parent. Parents in the IG arm will receive a bespoke designed booklet containing

BEHAVIORAL

Standard speech therapy intervention

The standard speech therapy intervention, as typically conducted in rehabilitation centers, consists of 8 weekly sessions, each lasting 45 minutes, over a two-month period (same as the experimental intervention). During these sessions, the therapist may provide various stimulations aimed at enhancing the child's vocalization, verbal comprehension, and speech production. While the therapist may offer guidance to parents on how to continue these stimulations in daily routines, they will not be directly involved in the sessions unless strictly necessary.

Sponsors & Collaborators

• Associazione La Nostra Famiglia, Como, Italy

  collaborator UNKNOWN

• IRCCS Eugenio Medea

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

59 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-19

Primary Completion

2026-07-31

Completion

2026-09-01

Countries

• Italy

Study Locations