Efficacy of an Early Rhythmic Intervention in Infancy

Official title

Electrophysiological Markers in Language and Learning Impairment: Early Intervention and Long-term Follow-up

Overview

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.

Interventions

• Behavioral Rhythmic intervention
  The rhythmic intervention consists in an ecological and non-invasive intervention based on enriched auditory and musical active experience. It is based on the most recent scientific evidence in the field and provides exposure to and active synchronization with complex musical rhythms. It is thought to promote the infant's ability to recognize and process the complex rhythms of spoken language. Importantly, it taps into and empowers early auditory processing skills. The intervention includes seve
• Behavioral Passive auditory stimulation
  The same auditory stimulation is provided to infants, but no active tasks are proposed. Children and caregiver are entertained with motor and cognitive tasks not related to the auditory stimuli presented. The intervention takes place in small groups of infant-caregiver pairs (N=4/5) for 1 hour/week for 6 weeks.

Primary outcome measures

• Electrophysiological markers in a task tapping neural entrainment administered immediately after the end on the intervention (or at comparable age). [Time frame: Age 10-11 months.]
• Electrophysiological markers in a task tapping neural entrainment administered at age 18 months. [Time frame: Age 18 months.]
• Electrophysiological markers (obligatory peak) in a non-speech multi-feature oddball paradigm administered at age 12 months. [Time frame: Age 12 months]
• Electrophysiological markers (MisMatch Response) in a non-speech multi-feature oddball paradigm administered at age 12 months. [Time frame: Age 12 months]
• Electrophysiological markers (obligatory peak) in a non-speech multi-feature oddball paradigm administered at age 24 months. [Time frame: Age 24 months]
• Electrophysiological markers (Mismatch Response) in a non-speech multi-feature oddball paradigm administered at age 24 months. [Time frame: Age 24 months]

Secondary outcome measures (8)

• Expressive Language at age 12 months assessed through the Bayley Scales of Infant and Toddler Development. [Time frame: Age 12 months]
• Expressive Language at age 24 months assessed through the Bayley Scales of Infant and Toddler Development. [Time frame: Age 24 months]
• Receptive Language at age 12 months assessed through the Bayley Scales of Infant and Toddler Development. [Time frame: Age 12 months]
• Receptive Language at age 24 months assessed through the Bayley Scales of Infant and Toddler Development. [Time frame: Age 24 months]
• Expressive vocabulary at age 20 months assessed through the Language Development Survey [Time frame: Age 20 months]
• Expressive vocabulary at age 24 months assessed through the Language Development Survey [Time frame: Age 24 months]
• Mean Length Utterance assessed through the Language Development Survey [Time frame: Age 24 months]
• Receptive vocabulary assessed through the Picture Naming Game. [Time frame: Age 20 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Italy · 1 center

• IRCCS Eugenio Medea — Bosisio Parini

Identifiers

NCT: NCT04755309 · 629

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗