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 range
8 Months – 12 Months
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)