protocolSection identificationModule nctId: NCT06261307, orgStudyIdInfo id: 13462111, briefTitle: Language Development Deficits and Early Interactive Music Intervention, acronym: BusyBaby, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: University of Helsinki, class: OTHER, collaborators name: Folkhälsan Research Center, collaborators name: Karolinska Institutet, collaborators name: University of Turku, collaborators name: University of Jyvaskyla, collaborators name: Academy of Finland, descriptionModule briefSummary: 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., conditionsModule conditions: Dyslexia, Developmental, conditions: Language Development Disorders, conditions: Language Development, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The experimental arm will receive music training and the control arm will receive circus training., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: 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., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Music intervention, interventions name: Circus intervention, outcomesModule primaryOutcomes measure: Infant-Toddler Checklist (ITC), primaryOutcomes measure: MacArthur-Bates Communicative Development Inventory (MCDI) 8-16mo, primaryOutcomes measure: Mismatch response (MMR) speech, amplitude, primaryOutcomes measure: Mismatch response (MMR) speech, latency, primaryOutcomes measure: Mismatch response (MMR) speech, laterality, primaryOutcomes measure: Obligatory event-related potential (ERP) speech, amplitude, primaryOutcomes measure: Obligatory event-related potential (ERP) speech, latency, primaryOutcomes measure: Obligatory event-related potential (ERP) speech, laterality, secondaryOutcomes measure: Infant-Toddler Checklist (ITC) follow-up, secondaryOutcomes measure: MacArthur-Bates Communicative Development Inventory (MCDI) 16-30mo follow-up, secondaryOutcomes measure: Mismatch response (MMR) speech, amplitude follow-up, secondaryOutcomes measure: Mismatch response (MMR) speech, latency follow-up, secondaryOutcomes measure: Mismatch response (MMR) speech, laterality follow-up, secondaryOutcomes measure: Obligatory event-related potential (ERP) speech, amplitude follow-up, secondaryOutcomes measure: Obligatory event-related potential (ERP) speech, latency follow-up, secondaryOutcomes measure: Obligatory event-related potential (ERP) speech, laterality follow-up, secondaryOutcomes measure: Reynell Developmental Language Scales III (RDLS-III), secondaryOutcomes measure: Infant Behavior Questionnaire Revised short form (IBQ-R-sf), secondaryOutcomes measure: Early Childhood Behavior Questionnaire short form (ECBQ-sf), secondaryOutcomes measure: Parenting Stress Index Short Form (PSI-sf), secondaryOutcomes measure: Brief Infant-Toddler Social Emotional Assessment (BITSEA), otherOutcomes measure: Parental dyslexia status (dyslexia - no dyslexia), otherOutcomes measure: Allele groupings for dyslexia susceptibility genes, otherOutcomes measure: Gross and fine motor development, otherOutcomes measure: Bayley Scales III Motor scale, otherOutcomes measure: Mismatch response (MMR) music, amplitude, otherOutcomes measure: Mismatch response (MMR) music, latency, otherOutcomes measure: Mismatch response (MMR) music, laterality, otherOutcomes measure: Obligatory event-related potential (ERP) music, amplitude, otherOutcomes measure: Obligatory event-related potential (ERP) music, latency, otherOutcomes measure: Obligatory event-related potential (ERP) music, laterality, otherOutcomes measure: Music test scores (three parts of MMBB-MB), otherOutcomes measure: Music-related activities, otherOutcomes measure: Musical background of parents, otherOutcomes measure: Home literacy, otherOutcomes measure: Multilingualism, otherOutcomes measure: Screen time, eligibilityModule sex: ALL, minimumAge: 8 Months, maximumAge: 12 Months, stdAges: CHILD, contactsLocationsModule locations facility: University of Helsinki, status: RECRUITING, city: Helsinki, zip: 00014, country: Finland, contacts name: Paula Virtala, PhD, role: CONTACT, phone: +358408446907, email: paula.virtala@helsinki.fi, geoPoint lat: 60.16952, lon: 24.93545, hasResults: False