Dyslexia, DevelopmentalBusyBabyNCT06261307
Language Development Deficits and Early Interactive Music Intervention
A study testing Music intervention and Circus intervention in people with Dyslexia, Developmental and Language Development Disorders, run by University of Helsinki at 1 site in Finland.
Trial 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). Read more about this study
- Who is it for?
- Ages 8 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Dyslexia, Developmental, Language Development Disorders, Language Development
- What is being tested?
- Music intervention and Circus intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFinland
- Study dates
- 11 Mar 2024to Apr 2027
- 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 8 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Language Development Deficits and Early Interactive Music Intervention - a Randomized Controlled Trial (BusyBaby)
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.
Read the 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.
- Being tested
- Music intervention, Circus intervention
- Keywords
- Event-related potentials, Music intervention, Brain development, Speech processing
- Medical subject headings
- Dyslexia, Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionBehavioural
Group intervention focusing on musical activities
Circus interventionBehavioural
Group intervention focusing on acrobatics and circus activities
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Circus intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At baseline and at 6 months (post intervention)
Secondary outcomes (13)
Infant-Toddler Checklist (ITC) follow-up
Total and sub-scale scores in the standardized parental 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.
Measured: At 1-year follow-up (1.5 years from baseline)
MacArthur-Bates Communicative Development Inventory (MCDI) 16-30mo follow-up
Size of expressive vocabulary (amount of words out of a total of 595 words) and mean length of utterance (mean number of morphemes in the three longest utterances used by the child) in a parental standardized questionnaire on early language skills: the MacArthur-Bates Communicative Development Inventory (MCDI; Fenson et al., 1991; in Finnish: Lyytinen, 1999)
Measured: At 1-year follow-up (1.5 years from baseline)
Mismatch response (MMR) speech, amplitude follow-up
Amplitude (in milliseconds) of mismatch responses to speech sound deviants in an oddball paradigm recorded with electroencephalogram (EEG) from a fronto-central region-of-interest
Measured: At 1-year follow-up (1.5 years from baseline)
Mismatch response (MMR) speech, latency follow-up
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
Measured: At 1-year follow-up (1.5 years from baseline)
Mismatch response (MMR) speech, laterality follow-up
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
Measured: At 1-year follow-up (1.5 years from baseline)
Obligatory event-related potential (ERP) speech, amplitude follow-up
Amplitude (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
Measured: At 1-year follow-up (1.5 years from baseline)
Obligatory event-related potential (ERP) speech, latency follow-up
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
Measured: At 1-year follow-up (1.5 years from baseline)
Obligatory event-related potential (ERP) speech, laterality follow-up
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
Measured: At 1-year follow-up (1.5 years from baseline)
Reynell Developmental Language Scales III (RDLS-III)
Expressive and Comprehension Scale scores in the standardized language test battery Reynell Developmental Language Scales III (Reynell and Huntley, 2001). The range of scores is 0-62 for both scales, higher scores reflecting better language abilities.
Measured: At 6 months (post intervention) and at 1-year follow-up (1.5 years from baseline)
Infant Behavior Questionnaire Revised short form (IBQ-R-sf)
Factor scores in a parental standardized questionnaire on infant temperament at baseline: Infant Behavior Questionnaire Revised short form (IBQ-R, Putnam et al. 2014). The range of scores, with higher scores reflecting stronger trait, for the three factors are, for Negative affectivity, 1-6.25, for Surgency/Extraversion, 1-6.66, and for Orienting/Regulation/Effortful control, 1-6.5.
Measured: At baseline
Early Childhood Behavior Questionnaire short form (ECBQ-sf)
Factor scores in a parental standardized questionnaire on early childhood temperament at six months and 1.5 years from baseline: Early Childhood Behavior Questionnaire short form (ECBQ-sf, Putnam et al. 2010). The range of scores, with higher scores reflecting stronger trait, for the three factors are, for Negative affectivity, 1-6, for Surgency/Extraversion, 1-5.4, and for Orienting/Regulation/Effortful control, 1-6.4. The questionnaire is continuation to the Infant Behavior Questionnaire Revised short form (IBQ-R-sf), allowing the analysis of change in factor scores from baseline.
Measured: At 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
Parenting Stress Index Short Form (PSI-sf)
Factor and total stress scores in a parental standardized questionnaire on parental well-being and stress and interaction with child: Parenting Stress Index Short Form (PSI-sf, Abidin, 1995). The range of scores is 12-60 for the three factors Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child, and sum of these (36-180) for the Total score, with higher scores indicating more challenges (poorer parental well-being, more stress, and more dysfunctional interaction with the child).
Measured: At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
Brief Infant-Toddler Social Emotional Assessment (BITSEA)
Problem and Competence scores in a parental standardized questionnaire on social-emotional/behavioral problems and delays in social-emotional competence: Brief Infant-Toddler Social Emotional Assessment (BITSEA, Briggs-Gowan et al. 2004). The range for the Problem scores is 0-62, higher scores reflecting more problems in social-emotional skills or behavior. The range for the Competence scores is 0-22, higher scores reflecting better social-emotional competence. Both the scores and their percentile rankings (dependent on age and gender of the child, lower percentile always indicating worse performance) are analyzed.
Measured: At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start11 Mar 2024
- Primary completion27 Apr 2026
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dyslexia, DevelopmentalStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The experimental arm will receive music training and the control arm will receive circus training.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Folkhälsan Research Center, Karolinska Institutet, University of Turku, University of Jyvaskyla, Academy of Finland
- Responsible party
- Principal investigator, Paula Virtala, University of Helsinki
- Investigators
- Paula Virtala, PhD, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261307
- Sponsor's protocol ID
- 13462111
- Acronym
- BusyBaby
- Status last verified
- Apr 2026
- First submitted
- 17 Jan 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37350469Kujala 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.
PubMed 34035329Virtala 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.
PubMed 41561604
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Language Development Deficits and Early Interactive Music Intervention - a Randomized Controlled Trial (BusyBaby)
- ClinicalTrials.gov ID
- NCT06261307
- Acronym / sponsor ID
- BusyBaby / 13462111
- Keywords
- Event-related potentials, Music intervention, Brain development, Speech processing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Folkhälsan Research Center, Karolinska Institutet, University of Turku, University of Jyvaskyla, Academy of Finland
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 27 Apr 2026 (actual)
- Study completion
- Apr 2027 (estimated)
- First posted
- 15 Feb 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The experimental arm will receive music training and the control arm will receive circus training.
| Arm | Type | Receives |
|---|---|---|
| Music intervention | Experimental | Behavioral: Music interventionGroups: 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. |
| Circus intervention | Active comparator | Behavioral: Circus interventionGroups: 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. |
Who may qualify
- Ages
- 8 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Music interventionGroup intervention focusing on musical activities | Behavioural | Music intervention |
| Circus interventionGroup intervention focusing on acrobatics and circus activities | Behavioural | Circus intervention |
Primary outcome
Infant-Toddler Checklist (ITC)
Time frame: At baseline and at 6 months (post intervention)
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.
MacArthur-Bates Communicative Development Inventory (MCDI) 8-16mo
Time frame: At baseline and at 6 months (post intervention)
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)
Mismatch response (MMR) speech, amplitude
Time frame: At baseline and at 6 months (post intervention)
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
Mismatch response (MMR) speech, latency
Time frame: At baseline and at 6 months (post intervention)
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
Mismatch response (MMR) speech, laterality
Time frame: At baseline and at 6 months (post intervention)
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
Obligatory event-related potential (ERP) speech, amplitude
Time frame: At baseline and at 6 months (post intervention)
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
Obligatory event-related potential (ERP) speech, latency
Time frame: At baseline and at 6 months (post intervention)
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
Obligatory event-related potential (ERP) speech, laterality
Time frame: At baseline and at 6 months (post intervention)
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
13 secondary outcomes
Infant-Toddler Checklist (ITC) follow-up
Time frame: At 1-year follow-up (1.5 years from baseline)
MacArthur-Bates Communicative Development Inventory (MCDI) 16-30mo follow-up
Time frame: At 1-year follow-up (1.5 years from baseline)
Mismatch response (MMR) speech, amplitude follow-up
Time frame: At 1-year follow-up (1.5 years from baseline)
Mismatch response (MMR) speech, latency follow-up
Time frame: At 1-year follow-up (1.5 years from baseline)
Mismatch response (MMR) speech, laterality follow-up
Time frame: At 1-year follow-up (1.5 years from baseline)
Obligatory event-related potential (ERP) speech, amplitude follow-up
Time frame: At 1-year follow-up (1.5 years from baseline)
Obligatory event-related potential (ERP) speech, latency follow-up
Time frame: At 1-year follow-up (1.5 years from baseline)
Obligatory event-related potential (ERP) speech, laterality follow-up
Time frame: At 1-year follow-up (1.5 years from baseline)
Reynell Developmental Language Scales III (RDLS-III)
Time frame: At 6 months (post intervention) and at 1-year follow-up (1.5 years from baseline)
Infant Behavior Questionnaire Revised short form (IBQ-R-sf)
Time frame: At baseline
Early Childhood Behavior Questionnaire short form (ECBQ-sf)
Time frame: At 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
Parenting Stress Index Short Form (PSI-sf)
Time frame: At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
Brief Infant-Toddler Social Emotional Assessment (BITSEA)
Time frame: At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
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 4 May 2026.
- Background: PubMed 37350469Paula 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.
- Background: PubMed 34035329Kujala 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.
- Derived from this study: PubMed 41561604Virtala 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.
- 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. This study is not recruiting at the moment.
Paula Virtala, PhD principal investigator
University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music intervention and Circus intervention in people with Dyslexia, Developmental and Language Development Disorders, run by University of Helsinki at 1 site in Finland.
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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. 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 Finland. 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?
Infant-Toddler Checklist (ITC) (time frame: At baseline and at 6 months (post intervention)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06261307, which also lists 3 linked publications.
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 4 May 2026.