Efficacy of an Early Rhythmic Intervention in Infancy

NCT04755309 | Enrolling By Invitation

• 1 other identifier: 629
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Language Development; Language Development Disorders; Infant Development; Intervention

Outcome Measures

Primary Outcomes (6)

• Electrophysiological markers in a task tapping neural entrainment administered immediately after the end on the intervention (or at comparable age).

  Early neural mechanisms supporting speech and acoustic perception are recorded in response to non-speech and speech rhythmic stimuli modulated at different rates. Neural entrainment to the incoming rhythms is measured in the form of peaks emerging from the EEG spectrum at frequencies corresponding to the rhythm envelope.

  Age 10-11 months.

• Electrophysiological markers in a task tapping neural entrainment administered at age 18 months.

  Early neural mechanisms supporting speech and acoustic perception are recorded in response to non-speech and speech rhythmic stimuli modulated at different rates. Neural entrainment to the incoming rhythms is measured in the form of peaks emerging from the EEG spectrum at frequencies corresponding to the rhythm envelope.

  Age 18 months.

• Electrophysiological markers (obligatory peak) in a non-speech multi-feature oddball paradigm administered at age 12 months.

  In the non-speech multi-feature paradigm, pairs of complex tones are presented at a rapid rate (70ms inter-stimulus interval) and stimuli differing in either frequency or duration serve as deviants. Latency of the obligatory peak (P1/P2) are computed.

  Age 12 months

• Electrophysiological markers (MisMatch Response) in a non-speech multi-feature oddball paradigm administered at age 12 months.

  In the non-speech multi-feature paradigm, pairs of complex tones are presented at a rapid rate (70ms inter-stimulus interval) and stimuli differing in either frequency or duration serve as deviants. Mean amplitude of the MisMatch Response is computed.

  Age 12 months

• Electrophysiological markers (obligatory peak) in a non-speech multi-feature oddball paradigm administered at age 24 months.

  In the non-speech multi-feature paradigm, pairs of complex tones are presented at a rapid rate (70ms inter-stimulus interval) and stimuli differing in either frequency or duration serve as deviants. Latency of the obligatory peak (P1/P2) are computed.

  Age 24 months

• Electrophysiological markers (Mismatch Response) in a non-speech multi-feature oddball paradigm administered at age 24 months.

  In the non-speech multi-feature paradigm, pairs of complex tones are presented at a rapid rate (70ms inter-stimulus interval) and stimuli differing in either frequency or duration serve as deviants. Mean amplitude of the MisMatch Response is computed.

  Age 24 months

Secondary Outcomes (8)

• Expressive Language at age 12 months assessed through the Bayley Scales of Infant and Toddler Development.

  Age 12 months

• Expressive Language at age 24 months assessed through the Bayley Scales of Infant and Toddler Development.

  Age 24 months

• Receptive Language at age 12 months assessed through the Bayley Scales of Infant and Toddler Development.

  Age 12 months

• Receptive Language at age 24 months assessed through the Bayley Scales of Infant and Toddler Development.

  Age 24 months

• Expressive vocabulary at age 20 months assessed through the Language Development Survey

  Age 20 months

Study Arms (5)

Typical development infants - experimental

EXPERIMENTAL

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

Behavioral: Rhythmic intervention

Typical development infants - spontaneous development

NO INTERVENTION

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

Typical development infants - control

ACTIVE COMPARATOR

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

Behavioral: Passive auditory stimulation

Infants at familial risk - experimental

EXPERIMENTAL

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

Behavioral: Rhythmic intervention

Infants at familial risk - spontaneous development

NO INTERVENTION

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

Interventions

Rhythmic intervention BEHAVIORAL

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 several tasks described in the literature, for example tapping and bouncing at the beat of complex musical rhythms. The intervention takes place in small groups of infant-caregiver pairs (N=4/5) for 1 hour/week for 6 weeks.

Infants at familial risk - experimental; Typical development infants - experimental

Passive auditory stimulation BEHAVIORAL

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.

Typical development infants - control

Eligibility Criteria

• Age: 6 Months - 9 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (1)

IRCCS Eugenio Medea

Bosisio Parini, LC, 23842, Italy

Location

MeSH Terms

Conditions

Language Development Disorders

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 16, 2021
• Study Start: February 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)