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Efficacy of an Early Rhythmic Intervention in Infancy

Primary Purpose

Language Development, Language Development Disorders, Infant Development

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Rhythmic intervention
Passive auditory stimulation
Sponsored by
IRCCS Eugenio Medea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Language Development

Eligibility Criteria

6 Months - 9 Months (Child)All SexesAccepts 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.

Sites / Locations

  • IRCCS Eugenio Medea

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

No Intervention

Active Comparator

Experimental

No Intervention

Arm Label

Typical development infants - experimental

Typical development infants - spontaneous development

Typical development infants - control

Infants at familial risk - experimental

Infants at familial risk - spontaneous development

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Expressive Language at age 12 months assessed through the Bayley Scales of Infant and Toddler Development.
Expressive language subscale of the Bayley Scales of Infant and Toddler Development. Scaled scores by age (Mean = 10, Standard Deviation = 3) are computed. Higher scores mean better performance.
Expressive Language at age 24 months assessed through the Bayley Scales of Infant and Toddler Development.
Expressive language subscale of the Bayley Scales of Infant and Toddler Development. Scaled scores by age (Mean = 10, Standard Deviation = 3) are computed. Higher scores mean better performance.
Receptive Language at age 12 months assessed through the Bayley Scales of Infant and Toddler Development.
Receptive language subscale of the Bayley Scales of Infant and Toddler Development. Scaled scores by age (Mean = 10, Standard Deviation = 3) are computed. Higher scores mean better performance.
Receptive Language at age 24 months assessed through the Bayley Scales of Infant and Toddler Development.
Receptive language subscale of the Bayley Scales of Infant and Toddler Development. Scaled scores by age (Mean = 10, Standard Deviation = 3) are computed. Higher scores mean better performance.
Expressive vocabulary at age 20 months assessed through the Language Development Survey
Number of words spontaneously produced by children, assessed through the Language Development Survey. The percentile score based on gender-specific norms is used. Higher scores mean better performance.
Expressive vocabulary at age 24 months assessed through the Language Development Survey
Number of words spontaneously produced by children, assessed through the Language Development Survey. The percentile score based on gender-specific norms is used. Higher scores mean better performance.
Mean Length Utterance assessed through the Language Development Survey
Number of words in the five longest spontaneous utterances, assessed through the Language Development Survey. The percentile score based on gender-specific norms is used. Higher scores mean better performance.
Receptive vocabulary assessed through the Picture Naming Game.
Receptive vocabulary assessed through the Picture Naming Game. The z-score based on age-specific norms is used (Mean = 0, Standard Deviation = 1). Higher scores mean better performance.

Full Information

First Posted
February 5, 2021
Last Updated
September 28, 2023
Sponsor
IRCCS Eugenio Medea
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1. Study Identification

Unique Protocol Identification Number
NCT04755309
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Eugenio Medea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Language Development, Language Development Disorders, Infant Development, Intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Typical development infants - experimental
Arm Type
Experimental
Arm Description
Children without familial risk for language disorders, who participate to the rhythmic intervention.
Arm Title
Typical development infants - spontaneous development
Arm Type
No Intervention
Arm Description
No intervention is provided and typical development in children without familial risk for language disorders is evaluated.
Arm Title
Typical development infants - control
Arm Type
Active Comparator
Arm Description
Children without familial risk for language disorders, who are exposed to passive auditory stimulation.
Arm Title
Infants at familial risk - experimental
Arm Type
Experimental
Arm Description
Children with familial risk for language disorders, who participate to the rhythmic intervention.
Arm Title
Infants at familial risk - spontaneous development
Arm Type
No Intervention
Arm Description
No intervention is provided and typical development in children without familial risk for language disorders is evaluated.
Intervention Type
Behavioral
Intervention Name(s)
Rhythmic intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Passive auditory stimulation
Intervention Description
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 Measure Information:
Title
Electrophysiological markers in a task tapping neural entrainment administered immediately after the end on the intervention (or at comparable age).
Description
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.
Time Frame
Age 10-11 months.
Title
Electrophysiological markers in a task tapping neural entrainment administered at age 18 months.
Description
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.
Time Frame
Age 18 months.
Title
Electrophysiological markers (obligatory peak) in a non-speech multi-feature oddball paradigm administered at age 12 months.
Description
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.
Time Frame
Age 12 months
Title
Electrophysiological markers (MisMatch Response) in a non-speech multi-feature oddball paradigm administered at age 12 months.
Description
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.
Time Frame
Age 12 months
Title
Electrophysiological markers (obligatory peak) in a non-speech multi-feature oddball paradigm administered at age 24 months.
Description
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.
Time Frame
Age 24 months
Title
Electrophysiological markers (Mismatch Response) in a non-speech multi-feature oddball paradigm administered at age 24 months.
Description
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.
Time Frame
Age 24 months
Secondary Outcome Measure Information:
Title
Expressive Language at age 12 months assessed through the Bayley Scales of Infant and Toddler Development.
Description
Expressive language subscale of the Bayley Scales of Infant and Toddler Development. Scaled scores by age (Mean = 10, Standard Deviation = 3) are computed. Higher scores mean better performance.
Time Frame
Age 12 months
Title
Expressive Language at age 24 months assessed through the Bayley Scales of Infant and Toddler Development.
Description
Expressive language subscale of the Bayley Scales of Infant and Toddler Development. Scaled scores by age (Mean = 10, Standard Deviation = 3) are computed. Higher scores mean better performance.
Time Frame
Age 24 months
Title
Receptive Language at age 12 months assessed through the Bayley Scales of Infant and Toddler Development.
Description
Receptive language subscale of the Bayley Scales of Infant and Toddler Development. Scaled scores by age (Mean = 10, Standard Deviation = 3) are computed. Higher scores mean better performance.
Time Frame
Age 12 months
Title
Receptive Language at age 24 months assessed through the Bayley Scales of Infant and Toddler Development.
Description
Receptive language subscale of the Bayley Scales of Infant and Toddler Development. Scaled scores by age (Mean = 10, Standard Deviation = 3) are computed. Higher scores mean better performance.
Time Frame
Age 24 months
Title
Expressive vocabulary at age 20 months assessed through the Language Development Survey
Description
Number of words spontaneously produced by children, assessed through the Language Development Survey. The percentile score based on gender-specific norms is used. Higher scores mean better performance.
Time Frame
Age 20 months
Title
Expressive vocabulary at age 24 months assessed through the Language Development Survey
Description
Number of words spontaneously produced by children, assessed through the Language Development Survey. The percentile score based on gender-specific norms is used. Higher scores mean better performance.
Time Frame
Age 24 months
Title
Mean Length Utterance assessed through the Language Development Survey
Description
Number of words in the five longest spontaneous utterances, assessed through the Language Development Survey. The percentile score based on gender-specific norms is used. Higher scores mean better performance.
Time Frame
Age 24 months
Title
Receptive vocabulary assessed through the Picture Naming Game.
Description
Receptive vocabulary assessed through the Picture Naming Game. The z-score based on age-specific norms is used (Mean = 0, Standard Deviation = 1). Higher scores mean better performance.
Time Frame
Age 20 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
9 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
IRCCS Eugenio Medea
City
Bosisio Parini
State/Province
LC
ZIP/Postal Code
23842
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of an Early Rhythmic Intervention in Infancy

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