Clinical trial NCT06261307: Language Development Deficits and Early Interactive Music Intervention
Official title: Language Development Deficits and Early Interactive Music Intervention - a Randomized Controlled Trial (BusyBaby)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dyslexia, Developmental
Language Development Disorders
Language Development
Keywords: Event-related potentials
Music intervention
Brain development
Speech processing
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Folkhälsan Research Center
name: Karolinska Institutet
name: University of Turku
name: University of Jyvaskyla
name: Academy of Finland
First posted: 2024-02-15
Enrollment: 200
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The experimental arm will receive music training and the control arm will receive circus training.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Infant-Toddler Checklist (ITC)
timeFrame: At baseline and at 6 months (post intervention)
measure: MacArthur-Bates Communicative Development Inventory (MCDI) 8-16mo
timeFrame: At baseline and at 6 months (post intervention)
measure: Mismatch response (MMR) speech, amplitude
timeFrame: At baseline and at 6 months (post intervention)
measure: Mismatch response (MMR) speech, latency
timeFrame: At baseline and at 6 months (post intervention)
measure: Mismatch response (MMR) speech, laterality
timeFrame: At baseline and at 6 months (post intervention)
measure: Obligatory event-related potential (ERP) speech, amplitude
timeFrame: At baseline and at 6 months (post intervention)
measure: Obligatory event-related potential (ERP) speech, latency
timeFrame: At baseline and at 6 months (post intervention)
measure: Obligatory event-related potential (ERP) speech, laterality
timeFrame: At baseline and at 6 months (post intervention)
Secondary outcomes:
measure: Infant-Toddler Checklist (ITC) follow-up
timeFrame: At 1-year follow-up (1.5 years from baseline)
measure: MacArthur-Bates Communicative Development Inventory (MCDI) 16-30mo follow-up
timeFrame: At 1-year follow-up (1.5 years from baseline)
measure: Mismatch response (MMR) speech, amplitude follow-up
timeFrame: At 1-year follow-up (1.5 years from baseline)
measure: Mismatch response (MMR) speech, latency follow-up
timeFrame: At 1-year follow-up (1.5 years from baseline)
measure: Mismatch response (MMR) speech, laterality follow-up
timeFrame: At 1-year follow-up (1.5 years from baseline)
measure: Obligatory event-related potential (ERP) speech, amplitude follow-up
timeFrame: At 1-year follow-up (1.5 years from baseline)
measure: Obligatory event-related potential (ERP) speech, latency follow-up
timeFrame: At 1-year follow-up (1.5 years from baseline)
measure: Obligatory event-related potential (ERP) speech, laterality follow-up
timeFrame: At 1-year follow-up (1.5 years from baseline)
measure: Reynell Developmental Language Scales III (RDLS-III)
timeFrame: At 6 months (post intervention) and at 1-year follow-up (1.5 years from baseline)
measure: Infant Behavior Questionnaire Revised short form (IBQ-R-sf)
timeFrame: At baseline
measure: Early Childhood Behavior Questionnaire short form (ECBQ-sf)
timeFrame: At 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
measure: Parenting Stress Index Short Form (PSI-sf)
timeFrame: At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
measure: Brief Infant-Toddler Social Emotional Assessment (BITSEA)
timeFrame: At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
Other outcomes:
measure: Parental dyslexia status (dyslexia - no dyslexia)
timeFrame: At enrollment to the study (before the children are accepted to the study and randomized)
measure: Allele groupings for dyslexia susceptibility genes
timeFrame: At baseline
measure: Gross and fine motor development
timeFrame: At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
measure: Bayley Scales III Motor scale
timeFrame: At 6 months (post-intervention) and at 1-year follow-up (1.5 years from baseline)
measure: Mismatch response (MMR) music, amplitude
timeFrame: At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
measure: Mismatch response (MMR) music, latency
timeFrame: At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
measure: Mismatch response (MMR) music, laterality
timeFrame: At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
measure: Obligatory event-related potential (ERP) music, amplitude
timeFrame: At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
measure: Obligatory event-related potential (ERP) music, latency
timeFrame: At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
measure: Obligatory event-related potential (ERP) music, laterality
timeFrame: At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
measure: Music test scores (three parts of MMBB-MB)
timeFrame: At 1-year follow-up (1.5 years from baseline)
measure: Music-related activities
timeFrame: At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
measure: Musical background of parents
timeFrame: At baseline
measure: Home literacy
timeFrame: At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
measure: Multilingualism
timeFrame: At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
measure: Screen time
timeFrame: At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
Locations:
city: Helsinki
country: Finland
facility: University of Helsinki
Study officials:
affiliation: University of Helsinki
name: Paula Virtala, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paula V, Vesa P, Anastasia G, Anja T, Laurel J T, Teija K. Beneficial effects of a music listening intervention on neural speech processing in 0-28-month-old children at risk for dyslexia. Dev Sci. 2023 Sep;26(5):e13426. doi: 10.1111/desc.13426. Epub 2023 Jun 23.
citation: Kujala T, Sihvonen AJ, Thiede A, Palo-Oja P, Virtala P, Numminen J, Laasonen M. Voxel and surface based whole brain analysis shows reading skill associated grey matter abnormalities in dyslexia. Sci Rep. 2021 May 25;11(1):10862. doi: 10.1038/s41598-021-89317-x.