Language DevelopmentNCT04755309
Efficacy of an Early Rhythmic Intervention in Infancy
A study testing Rhythmic intervention and Passive auditory stimulation in people with Language Development and Language Development Disorders, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 9 monthsHealthy volunteers can take part
- Conditions the study is for
- Language Development, Language Development Disorders, Infant Development
- What is being tested?
- Rhythmic intervention and Passive auditory stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Electrophysiological Markers in Language and Learning Impairment: Early Intervention and Long-term Follow-up
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.
- Being tested
- Rhythmic intervention, Passive auditory stimulation
- Medical subject headings
- Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythmic interventionBehavioural
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 stimulationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Typical development infants - experimental | Experimental | Children without familial risk for language disorders, who participate to the rhythmic intervention. Receives: 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. Receives: Behavioral: Passive auditory stimulation |
| Infants at familial risk - experimental | Experimental | Children with familial risk for language disorders, who participate to the rhythmic intervention. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Age 24 months
Secondary outcomes (8)
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.
Measured: Age 12 months
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.
Measured: Age 24 months
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.
Measured: Age 12 months
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.
Measured: Age 24 months
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.
Measured: Age 20 months
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.
Measured: Age 24 months
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.
Measured: Age 24 months
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.
Measured: Age 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start1 Feb 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Language DevelopmentStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755309
- Sponsor's protocol ID
- 629
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2021
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Markers in Language and Learning Impairment: Early Intervention and Long-term Follow-up
- ClinicalTrials.gov ID
- NCT04755309
- Acronym / sponsor ID
- 629
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Typical development infants - experimental | Experimental | Behavioral: Rhythmic interventionChildren without familial risk for language disorders, who participate to the 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 | Behavioral: Passive auditory stimulationChildren without familial risk for language disorders, who are exposed to passive auditory stimulation. |
| Infants at familial risk - experimental | Experimental | Behavioral: Rhythmic interventionChildren with familial risk for language disorders, who participate to the 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. |
Who may qualify
- Ages
- 6 to 9 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhythmic interventionThe 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. | Behavioural | Infants at familial risk - experimental, Typical development infants - experimental |
| Passive auditory stimulationThe 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. | Behavioural | Typical development infants - control |
Primary outcome
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhythmic intervention and Passive auditory stimulation in people with Language Development and Language Development Disorders, run by IRCCS Eugenio Medea at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.