Language Development Deficits and Early Interactive Music Intervention

NCT06261307 | Active Not Recruiting

• 1 other identifier: 13462111
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyslexia, Developmental; Language Development Disorders; Language Development

Keywords

Event-related potentials; Music intervention; Brain development; Speech processing

Outcome Measures

Primary Outcomes (8)

• Infant-Toddler Checklist (ITC)

  Total and sub-scale scores in the parental standardized questionnaire on prelinguistic skills: Infant-Toddler Checklist (ITC) in the Communication and Symbolic Behavior Scales Developmental Profile (Wetherby and Prizant, 2002; in Finnish: Laakso et al., 2011). Range of scores is 0-57 for the Total score, 0-26 for the Social subscale, 0-14 for the Speech subscale, and 0-17 for the Symbolic subscale, higher scores reflecting better prelinguistic skills.

  At baseline and at 6 months (post intervention)

• MacArthur-Bates Communicative Development Inventory (MCDI) 8-16mo

  Size of receptive and expressive vocabulary (amount of words out of a total of 380 words for each), and total score in the "gestures" scale (0-66, higher score reflecting better skills) in a parental standardized questionnaire on early language skills: the MacArthur-Bates Communicative Development Inventory (MCDI; Fenson et al., 1991; in Finnish: Lyytinen, 1999)

  At baseline and at 6 months (post intervention)

• Mismatch response (MMR) speech, amplitude

  Amplitude (in microvolts) of mismatch responses to speech sound deviants in an oddball paradigm recorded with electroencephalogram (EEG) from a fronto-central region-of-interest

  At baseline and at 6 months (post intervention)

• Mismatch response (MMR) speech, latency

  Peak latency (in milliseconds) of mismatch responses to speech sound deviants in an oddball paradigm recorded with electroencephalogram (EEG) from a fronto-central region-of-interest

  At baseline and at 6 months (post intervention)

• Mismatch response (MMR) speech, laterality

  Hemispheric lateralization (indicated with a laterality index, where range is from -1 to +1 with more positive values indicating a more left-lateralized response) of mismatch responses to speech sound deviants in an oddball paradigm recorded with electroencephalogram (EEG) from a fronto-central region-of-interest at left and right hemisphere

  At baseline and at 6 months (post intervention)

• Obligatory event-related potential (ERP) speech, amplitude

  Amplitude (in microvolts) of obligatory event-related potentials (ERPs) to repeating speech sounds in an oddball paradigm recorded with electroencephalogram (EEG) from a fronto-central region-of-interest

  At baseline and at 6 months (post intervention)

• Obligatory event-related potential (ERP) speech, latency

  Peak latency (in milliseconds) of obligatory event-related potentials (ERPs) to repeating speech sounds in an oddball paradigm recorded with electroencephalogram (EEG) from a fronto-central region-of-interest

  At baseline and at 6 months (post intervention)

• Obligatory event-related potential (ERP) speech, laterality

  Hemispheric lateralization (indicated with a laterality index, where range is from -1 to +1 with more positive values indicating a more left-lateralized response) of obligatory event-related potentials (ERPs) to repeating speech sounds in an oddball paradigm recorded with electroencephalogram (EEG) from a fronto-central region-of-interest at left and right hemisphere

  At baseline and at 6 months (post intervention)

Secondary Outcomes (13)

• Infant-Toddler Checklist (ITC) follow-up

  At 1-year follow-up (1.5 years from baseline)

• MacArthur-Bates Communicative Development Inventory (MCDI) 16-30mo follow-up

  At 1-year follow-up (1.5 years from baseline)

• Mismatch response (MMR) speech, amplitude follow-up

  At 1-year follow-up (1.5 years from baseline)

• Mismatch response (MMR) speech, latency follow-up

  At 1-year follow-up (1.5 years from baseline)

• Mismatch response (MMR) speech, laterality follow-up

  At 1-year follow-up (1.5 years from baseline)

Other Outcomes (16)

• Parental dyslexia status (dyslexia - no dyslexia)

  At enrollment to the study (before the children are accepted to the study and randomized)

• Allele groupings for dyslexia susceptibility genes

  At baseline

• Gross and fine motor development

  At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)

Study Arms (2)

Music intervention

EXPERIMENTAL

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.

Behavioral: Music intervention

Circus intervention

ACTIVE COMPARATOR

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.

Behavioral: Circus intervention

Interventions

Music intervention BEHAVIORAL

Group intervention focusing on musical activities

Music intervention

Circus intervention BEHAVIORAL

Group intervention focusing on acrobatics and circus activities

Circus intervention

Eligibility Criteria

• Age: 8 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Helsinki: lead
• Folkhälsan Research Center: collaborator
• Karolinska Institutet: collaborator
• University of Turku: collaborator
• University of Jyvaskyla: collaborator
• Academy of Finland: collaborator

Study Sites (1)

University of Helsinki

Helsinki, 00014, Finland

Location

Related Publications (3)

• 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.

  PMID: 37350469 BACKGROUND

• 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.

  PMID: 34035329 BACKGROUND

• Virtala P, Aquilino B, Nie P, Navarrete-Arroyo S, Stolt S, Leutonen K, Lauronen M, Kujala T. Language development deficits and early interactive music intervention (BusyBaby): protocol description of a double-blind randomized controlled trial on the effectiveness of music on language development in infancy. Front Psychol. 2026 Jan 5;16:1699558. doi: 10.3389/fpsyg.2025.1699558. eCollection 2025.

  PMID: 41561604 DERIVED

MeSH Terms

Conditions

Dyslexia; Language Development Disorders

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Specific Learning Disorder; Learning Disabilities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Paula Virtala, PhD

  University of Helsinki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University researcher

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

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 15, 2024
• Study Start: March 11, 2024
• Primary Completion: April 27, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)