Speech Therapy and Parenting for Early Socio-communicAtive sKills

NCT06666777 | Recruiting

• 1 other identifier: 1109
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 9

Brief 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

Keywords

Socio-communicative skills; early intervention; Speech therapy; Parenting; Parental support; Intersubjectivity; Neurodevelopmental disabilities

Outcome Measures

Primary Outcomes (3)

• Early socio-communicative skills

  \- Prelinguistic intersubjective and socio-communicative skills will be assessed through the observative checklist "Observation of Prelinguistic Intersubjective and Socio-Communicative Skills" (OPISCoS). The total raw score will be obtained by summing raw scores of all items. Higher scores indicate better early socio-communicative skills.

  Primary outcomes will be assessed at two time points: before the interventions (T0) and at the conclusion of the interventions, which will occur two months after the first session (T2).

• Communication and language development

  The MacArthur-Bates Communicative Development Inventory - short form will be fulfilled by parents to obtain an index of child language development. Higher scores indicate better developmental outcomes.

  Primary outcomes will be assessed at two time points: before the interventions (T0) and at the conclusion of the interventions, which will occur two months after the first session (T2).

• Parenting behavior

  A ten-minute parent-child interaction will be recorded and subsequently coded using the the "Parenting Interactions with Children Checklist of Observations Linked to Outcomes" (PICCOLO). This coding system an observational measure of developmentally supportive parental behavior, divided into four domains: affection, responsiveness, encouragement, teaching. Higher scores indicate more positive parenting behaviors.

  The parent-child interactions will be recorded and then coded with PICCOLO at two time points: before the interventions (T0) and at the conclusion of the interventions, which will occur two months after the first session (T2).

Secondary Outcomes (4)

• Early socio-cognitive skills

  This outcome will be assessed at two time points: before the interventions (T0) and at the conclusion of the interventions, which will occur two months after the first session (T2).

• Socio-emotional development

  This outcome will be assessed at two time points: before the interventions (T0) and at the conclusion of the interventions, which will occur two months after the first session (T2).

• Feasibility outcome measures

  This outcome will be assessed at the conclusion of the interventions, which will occur two months after the first session (T2)

• Acceptability and perceived efficacy measures

  This outcome will be assessed at the conclusion of the interventions, which will occur two months after the first session (T2)

Other Outcomes (5)

• Socio-demographic and clinical information

  This information will be collected before the intervention (T0).

• Child behavior

  This outcome will be collected before the intervention (T0).

• Parental depressive symptoms.

  This outcome will be collected before the intervention (T0).

Study Arms (2)

Experimental arm involving parents

EXPERIMENTAL

Subjects assigned to this arm will receive the intervention focused on intersubjective prelinguistic and socio-communicative skills. A parent is required to participate in all sessions.

Behavioral: Intervention focused on intersubjective prelinguistic and socio-communicative skills

Standard speech therapy

ACTIVE COMPARATOR

Participants in this group will receive standard speech therapy. Parental involvement will only occur if strictly necessary.

Behavioral: Standard speech therapy intervention

Interventions

Intervention focused on intersubjective prelinguistic and socio-communicative skills BEHAVIORAL

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

Also known as: SPEAK

Experimental arm involving parents

Standard speech therapy intervention BEHAVIORAL

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.

Standard speech therapy

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• For children:
• Age between 6 months (corrected age in cases of prematurity) and 5 years.
• Documented developmental delay and/or socio-communicative difficulties, based on clinical signs or standardized developmental scales (e.g., Griffiths Scales).
• Mental age of at least 6 months.
• Diagnosis of neurodevelopmental disability, including cerebral palsy, genetic syndromes, rare diseases with non-progressive neurological impairments, or congenital disorders of undetermined nature.
• For parents:
• Adult age (≥ 18 yo)
• Good knowledge and fluency in Italian.
• No manifest psychiatric conditions.
• No documented intellectual disability.

You may not qualify if:

• For children:
• Age greater than 5 years at the time of recruitment.
• Mental age below 6 months.
• Absence of developmental delay (developmental quotient \> 85) and socio-communicative difficulties.
• Diagnosis of neurodevelopmental disability resulting from neurodegenerative diseases or brain tumor outcomes.
• Severe sensory impairments (profound deafness and/or blindness).
• For Parents:
• Inability to speak Italian.
• Documented psychiatric conditions or intellectual disability.

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead
• Associazione La Nostra Famiglia, Como, Italy: collaborator

Study Sites (9)

Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale

Como, Como, 22100, Italy

RECRUITING

Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale e Diurno (CDC)

Ponte Lambro, Como, 22037, Italy

RECRUITING

Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale, Diurno (CDC) e Residenziale

Bosisio Parini, Lecco, 23842, Italy

RECRUITING

Associazione La Nostra Famiglia - IRCCS E. Medea

Bosisio Parini, Lecco, 23842, Italy

RECRUITING

Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale, Diurno (CDC) e Domiciliare

Lecco, Lecco, 23900, Italy

RECRUITING

Associazione "La Nostra Famiglia"- Centro di Riabilitazione Ambulatoriale

Sesto San Giovanni, Milano, 20099, Italy

RECRUITING

Associazione "La Nostra Famiglia"- Centro di Riabilitazione Ambulatoriale

Carate Brianza, Monza E Brianza, 20841, Italy

RECRUITING

Associazione "La Nostra Famiglia"- Centro di Riabilitazione Ambulatoriale

Cislago, Varese, 21040, Italy

RECRUITING

Associazione "La Nostra Famiglia"- Centro di Riabilitazione Ambulatoriale, Diurno (CDC)

Vedano Olona, Varese, 21040, Italy

RECRUITING

Related Publications (1)

• Porro C, Butti N, Sacchi D, Rigamonti R, Miccoli A, Montirosso R, Strazzer S. Speech therapy and parenting for early socio-communicative skills in young children with neurodevelopmental disabilities (SPEAK): study protocol for an Italian multicentre randomised controlled trial. BMJ Open. 2025 Nov 4;15(11):e102104. doi: 10.1136/bmjopen-2025-102104.

  PMID: 41193214 DERIVED

MeSH Terms

Conditions

Genetic Diseases, Inborn; Language Development Disorders; Communication Disorders

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Language Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Sandra Strazzer, M.D.

CONTACT

+39031877854; sandra.strazzer@lanostrafamiglia.it

Niccolò Butti, Ph.D.

CONTACT

+39031877464; niccolo.butti@lanostrafamiglia.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Psychologists administering the Bayley-III Socio-Emotional Questionnaire and ESB Battery, as well as evaluating parenting behavior using the PICCOLO, will be blinded to each participant's group assignment. However, due to the nature of the assessments and treatment, the therapists conducting OPISCoS cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 31, 2024
• Study Start: March 19, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

IT (9)