Clinical trial NCT04755309: Efficacy of an Early Rhythmic Intervention in Infancy
Official title: Electrophysiological Markers in Language and Learning Impairment: Early Intervention and Long-term Follow-up
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Language Development
Language Development Disorders
Infant Development
Intervention
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 125
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Electrophysiological markers in a task tapping neural entrainment administered immediately after the end on the intervention (or at comparable age).
timeFrame: Age 10-11 months.
measure: Electrophysiological markers in a task tapping neural entrainment administered at age 18 months.
timeFrame: Age 18 months.
measure: Electrophysiological markers (obligatory peak) in a non-speech multi-feature oddball paradigm administered at age 12 months.
timeFrame: Age 12 months
measure: Electrophysiological markers (MisMatch Response) in a non-speech multi-feature oddball paradigm administered at age 12 months.
timeFrame: Age 12 months
measure: Electrophysiological markers (obligatory peak) in a non-speech multi-feature oddball paradigm administered at age 24 months.
timeFrame: Age 24 months
measure: Electrophysiological markers (Mismatch Response) in a non-speech multi-feature oddball paradigm administered at age 24 months.
timeFrame: Age 24 months
Secondary outcomes:
measure: Expressive Language at age 12 months assessed through the Bayley Scales of Infant and Toddler Development.
timeFrame: Age 12 months
measure: Expressive Language at age 24 months assessed through the Bayley Scales of Infant and Toddler Development.
timeFrame: Age 24 months
measure: Receptive Language at age 12 months assessed through the Bayley Scales of Infant and Toddler Development.
timeFrame: Age 12 months
measure: Receptive Language at age 24 months assessed through the Bayley Scales of Infant and Toddler Development.
timeFrame: Age 24 months
measure: Expressive vocabulary at age 20 months assessed through the Language Development Survey
timeFrame: Age 20 months
measure: Expressive vocabulary at age 24 months assessed through the Language Development Survey
timeFrame: Age 24 months
measure: Mean Length Utterance assessed through the Language Development Survey
timeFrame: Age 24 months
measure: Receptive vocabulary assessed through the Picture Naming Game.
timeFrame: Age 20 months
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: IRCCS Eugenio Medea
state: LC
Study officials:
References: