Efficacy of an Early Rhythmic Intervention in Infancy
NCT04755309 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125
Last updated 2025-02-05
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
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 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.
- 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.
Sponsors & Collaborators
-
IRCCS Eugenio Medea
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Months
- Max Age
- 9 Months
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-02-01
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- Italy
Study Locations
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