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.
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.
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.
Parallel
Intervention focused on intersubjective prelinguistic and socio-communicative skills
BehavioralThe 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
Standard speech therapy intervention
BehavioralThe 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.
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.
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.
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.
Early socio-cognitive skills
The Early Socio-cognitive Battery (ESB) will be administered to assess socio-cognitive skills, such as social responsivity, joint attention and symbolic comprehension. Raw scores will be converted into standardized scores according to normative tables. Higher scores indicate better socio-cognitive skills.
Socio-emotional development
Socio-emotional development will be evaluated through the parent-reported questionnaire of the Bayley-3 scales. Higher scores indicate better developmental outcomes.
Feasibility outcome measures
Feasibility will be assessed by tracking the number of dropouts, namely the number of participants who fail to complete the eight-session intervention, and the number of sessions attended per child.
Acceptability and perceived efficacy measures
At T2, parents from both the IG and CG will complete a short questionnaire to provide subjective evaluations of the intervention's acceptability and perceived efficacy. The questionnaire will assess recommendation level and satisfaction, as well as parent's perception of their child's required effort, and the difficulties encountered in initiating and maintaining the intervention
Socio-demographic and clinical information
Information regarding clinical (e.g., diagnosis) and socio-demographic data (e.g., socio-economic status), will be collected from medical records or through specific questionnaires.
Child behavior
The parent-report Child Behavior Checklist (CBCL) 1½-5 \[57,58\] will be administered to assess the presence of emotional-behavioral problems (e.g., anxiety, sleep problems) in children older than 17 months. Raw scores will be converted into T-scores according to normative tables, with higher scores indicating greater problems.
Parental depressive symptoms.
Parents will be asked to fulfill the Beck Depression Inventory (BDI), which assesses the presence of depressive symptoms. Higher scores indicate increased depressive symptoms.
Parental anxiety
The parent-report State-Trait Anxiety Inventory (STAI-Y) will be administered to evaluate transient and stable states of anxiety. Higher scores indicate greater levels of state and trait anxiety symptomatology .
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IRCCS Eugenio Medea
Lead sponsor
Associazione La Nostra Famiglia, Como, Italy
Collaborator
