Language Development Deficits and Early Interactive Music Intervention

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-11

Study Completion Date

2027-03-31

Brief Summary

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Investigators compare effects of 6-month music versus circus group interventions on language development in infants and toddlers with or without familial risk for dyslexia (anticipated total N=200). Effects of intervention timing, dyslexia risk and genetics, and social-emotional factors on the intervention outcomes are investigated.

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Detailed Description

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Infancy and early childhood lay the base for language and reading abilities, and this development can be compromised by heritable conditions such as the reading deficit developmental dyslexia. One of the earliest indices of language abilities is neural processing of native language speech, as it is associated both with familial risk for developmental language and reading deficits and with subsequent language and reading development. Previous work has shown that musical activities can promote auditory and language learning early on and even improve reading in dyslexic children. Large-scale randomized controlled trials are needed particularly in risk groups in order to give recommendations and design effective interventions to support language development and ameliorate later difficulties. The investigators will conduct such a trial to study the effects of a playful music training group compared to a similar circus training group on speech processing and language development in infancy and early childhood. It is investigated how these effects are moderated by familial risk for dyslexia and its genetic markers as well as timing of the intervention in relation to the children's age and developmental status. Investigators study how the expected social-emotional benefits of the interventions on the parent, child, and their interaction mediate the intervention effects on language. Approximately 8-12-month-old infants with confirmed parental dyslexia or without parental dyslexia will be randomized, using block randomization, to one of the two 6-month training groups, and outcome measures will be collected before and after the intervention and at follow-up \~1 year after the intervention has ended. The total anticipated sample size is 200, with approximately 100 infants in the music and circus interventions and within each intervention, approximately 50 infants with and 50 without parental dyslexia. Speech processing will be evaluated with speech-elicited auditory event-related potentials, and language skills and general development with standardized parental questionnaires and age-appropriate standardized tests. Social-emotional factors are evaluated with parental questionnaires. DNA samples are collected to study dyslexia genetics. The results can contribute to designing effective interventions for supporting language development in vulnerable groups early on.

Conditions

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Dyslexia, Developmental Language Development Disorders Language Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The experimental arm will receive music training and the control arm will receive circus training.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

A dedicated member of the research team will be in charge of randomization of the participants to the two intervention arms, to ensure blindness of other team members. This member will not act as an outcomes assessor or a care provider.

The study will be presented to the caregivers as evaluating the effect of hobbies on language development. Therefore, the caregivers should not consider either intervention as the control arm. Both arms are expected to be potentially beneficial for the children's development.

Outcomes assessors will be unaware of the intervention arm and risk status (dyslexia risk vs no risk) of the children; caregivers will be reminded not to mention these to the researcher. Person in charge of randomization keeps track of violations of outcome assessor blindness.

Study Groups

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Music intervention

Groups: Children with (risk group, appr. 50%) or without (control group, appr. 50%) familial risk for dyslexia.

In each arm, the children will follow the same training protocol consisting of weekly 0.5-1-hour training sessions for six months. Training sessions are organized at fixed times and locations in fixed groups of 5-10 parent-child dyads and an experienced instructor.

The music intervention consists of social, structured and playful group sessions that involve joint singing, playing with musical instruments, moving to and listening to music. Based on the results of a previous intervention study by the investigators on the benefits of vocal music exposure on speech processing (Virtala et al., 2023), joint singing will be emphasized in the music intervention. The aims of the music intervention are to support caregiver-child interaction and the development of musical abilities.

Group Type EXPERIMENTAL

Music intervention

Intervention Type BEHAVIORAL

Group intervention focusing on musical activities

Circus intervention

Groups: Children with (risk group, appr. 50%) or without (control group, appr. 50%) familial risk for dyslexia.

In each arm, the children will follow the same training protocol consisting of weekly 0.5-1-hour training sessions for six months. Training sessions are organized at fixed times and locations in fixed groups of 5-10 parent-child dyads and an experienced instructor.

The circus intervention consists of social, structured and playful group sessions that involve acrobatics and other age-appropriate motor exercises with the caregiver, and familiarizing with the art and equipment of circus and acrobatics. The aims of the circus intervention are to support caregiver-child interaction and the development of motor skills.

Group Type ACTIVE_COMPARATOR

Circus intervention

Intervention Type BEHAVIORAL

Group intervention focusing on acrobatics and circus activities

Interventions

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Music intervention

Group intervention focusing on musical activities

Intervention Type BEHAVIORAL

Circus intervention

Group intervention focusing on acrobatics and circus activities

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 8-12 months old at start of intervention (recruited between 0-11 months)
* Born healthy and at term (gestational age at least 37 weeks and birth weight at least 2500 g)
* Normal hearing at birth (evoked oto-acoustic emissions conducted to newborns routinely at the hospital)
* At least one caregiver living with the child is native speaker of Finnish and speaks Finnish to the child
* Risk group: At least one biological parent has developmental dyslexia according to a recent (\<5 years) diagnostic statement by a health care professional or according to a dyslexia test at study enrollment; symptoms have started in childhood

Exclusion Criteria

* Medication affecting the central nervous system
* Sensory deficits
* Serious health conditions
* No-risk group: Suspected dyslexia or developmental language disorder due to symptoms that have started in childhood in either of the biological parents; diagnosis of a developmental or language disorder (incl. dyslexia, developmental language disorder, attention-deficit/hyperactivity disorder ADHD, attention-deficit disorder ADD) or neurological disorder in either of the biological parents
* Risk group: Diagnosis of ADHD, ADD, or other not-language-related developmental disorder in either of the biological parents; in the dyslexic parent, brain trauma in childhood that may indicate a non-heritable cause for the reading deficit or individualized school curriculum that may indicate broader developmental deficits.

Minimum Eligible Age

8 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes