Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
125 participants
INTERVENTIONAL
2021-02-01
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Typical development infants - experimental
Children without familial risk for language disorders, who participate to the rhythmic intervention.
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 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.
Typical development infants - spontaneous development
No intervention is provided and typical development in children without familial risk for language disorders is evaluated.
No interventions assigned to this group
Typical development infants - control
Children without familial risk for language disorders, who are exposed to passive auditory stimulation.
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.
Infants at familial risk - experimental
Children with familial risk for language disorders, who participate to the rhythmic intervention.
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 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 - spontaneous development
No intervention is provided and typical development in children without familial risk for language disorders is evaluated.
No interventions assigned to this group
Interventions
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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 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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
6 Months
9 Months
ALL
Yes
Sponsors
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IRCCS Eugenio Medea
OTHER
Responsible Party
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Locations
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IRCCS Eugenio Medea
Bosisio Parini, LC, Italy
Countries
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Other Identifiers
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629
Identifier Type: -
Identifier Source: org_study_id
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