Efficacy of an Early Rhythmic Intervention in Infancy

IRCCS Eugenio Medea

Status: Invitation-only

Conditions: Intervention; Language Development; Infant Development; Language Development Disorders

Treatments: Behavioral: Rhythmic intervention; Behavioral: Passive auditory stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04755309

629

Details and patient eligibility

About

The present project develops from a wide research line aiming at identifying very early electrophysiological risk markers for neurodevelopmental disorders. Long-term goals of the study include the characterization of language/learning developmental trajectories in children at high risk for language disorders and the implementation of ecological interventions based on enriched auditory experience to be employed to these children in an attempt to modify their atypical developmental trajectory before the emergence and crystallization of any behavioural symptoms and within the early period of known maximum cerebral plasticity.

Specifically, the main aim of this study is the development and implementation of an innovative and ecological early intervention based on environmental auditory enrichment (labelled "rhythmic intervention"). This intervention is tested both on a sample of typically developing infants and on a sample of infants at high familial risk for language disorders during a time span between 7 and 9 months of age. The efficacy of the intervention is tested on the electrophysiological markers tested before and after the intervention activities and on the linguistic outcomes within a longitudinal approach. The efficacy of such an intervention is compared to the spontaneous development observed in comparable groups of infants with and without familial risk for language disorders. In addition, only in a group of typically developing infants, a control intervention providing passive exposure to the same auditory stimulation is tested, in order to verify the specific contribution of the active participation of the children to the intervention.

The investigators hypothesize that the rhythmic intervention may modify the electrophysiological markers underlying auditory processing and the linguistic skills of all children, with a larger increase in infants at familial risk for language disorders who are specifically impaired in such skills.

Enrollment: 125 estimated patients

Sex: All

Ages: 6 to 9 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy infants aged between 6 and 9 months
• Infants with and without familial risk for language disorders (Infants are assigned to the group with familial risk for language disorders if at least one first-degree relative had a certified (clinical) diagnosis of language and/or learning disorders.
• Both parents are native-Italian speakers

Exclusion criteria

• Gestational age < 37 weeks and/or birth-weight < 2500 grams
• APGAR scores at birth at 1' and 5' < 7
• Bayley Cognitive Score < 7
• Presence of certified diagnosis of intellectual deficiency, attention-deficit disorder, sensorial and neurological disorders or autism within first-degree relatives.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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125 participants in 5 patient groups

Typical development infants - experimental

Experimental group

Description:

Children without familial risk for language disorders, who participate to the rhythmic intervention.

Treatment:

Behavioral: Rhythmic intervention

Typical development infants - spontaneous development

No Intervention group

Description:

No intervention is provided and typical development in children without familial risk for language disorders is evaluated.

Typical development infants - control

Active Comparator group

Description:

Children without familial risk for language disorders, who are exposed to passive auditory stimulation.

Treatment:

Behavioral: Passive auditory stimulation

Infants at familial risk - experimental

Experimental group

Description:

Children with familial risk for language disorders, who participate to the rhythmic intervention.

Treatment:

Behavioral: Rhythmic intervention

Infants at familial risk - spontaneous development

No Intervention group

Description:

No intervention is provided and typical development in children without familial risk for language disorders is evaluated.