Language Development Deficits and Early Interactive Music Intervention (NCT06261307) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Language Development Deficits and Early Interactive Music Intervention
Finland200 participantsStarted 2024-03-11
Plain-language 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.
Who can participate
Age range8 Months – 12 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Infant-Toddler Checklist (ITC)
Timeframe: At baseline and at 6 months (post intervention)
2
MacArthur-Bates Communicative Development Inventory (MCDI) 8-16mo
Timeframe: At baseline and at 6 months (post intervention)
3
Mismatch response (MMR) speech, amplitude
Timeframe: At baseline and at 6 months (post intervention)
4
Mismatch response (MMR) speech, latency
Timeframe: At baseline and at 6 months (post intervention)
5
Mismatch response (MMR) speech, laterality
Timeframe: At baseline and at 6 months (post intervention)