Dyslexia, Developmental, Language Development, Language Development Disorders
Conditions
Keywords
Event-related potentials, Music intervention, Brain development, Speech processing
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.
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.
Interventions
BEHAVIORALMusic intervention
Group intervention focusing on musical activities
BEHAVIORALCircus intervention
Group intervention focusing on acrobatics and circus activities
Sponsors
University of Helsinki
Folkhälsan Research Center
Karolinska Institutet
University of Turku
University of Jyvaskyla
Academy of Finland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
The experimental arm will receive music training and the control arm will receive circus training.
Eligibility
Sex/Gender
ALL
Age
8 Months to 12 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infant-Toddler Checklist (ITC) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infant-Toddler Checklist (ITC) follow-up | At 1-year follow-up (1.5 years from baseline) | 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. |
| MacArthur-Bates Communicative Development Inventory (MCDI) 16-30mo follow-up | At 1-year follow-up (1.5 years from baseline) | 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) |
| Mismatch response (MMR) speech, amplitude follow-up | At 1-year follow-up (1.5 years from baseline) | 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 |
| Mismatch response (MMR) speech, latency follow-up | At 1-year follow-up (1.5 years from baseline) | 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 follow-up | At 1-year follow-up (1.5 years from baseline) | 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 follow-up | At 1-year follow-up (1.5 years from baseline) | 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 |
| Obligatory event-related potential (ERP) speech, latency follow-up | At 1-year follow-up (1.5 years from baseline) | 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 follow-up | At 1-year follow-up (1.5 years from baseline) | 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 |
| Reynell Developmental Language Scales III (RDLS-III) | At 6 months (post intervention) and at 1-year follow-up (1.5 years from baseline) | 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. |
| Infant Behavior Questionnaire Revised short form (IBQ-R-sf) | At baseline | 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. |
| Early Childhood Behavior Questionnaire short form (ECBQ-sf) | At 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline) | 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. |
| Parenting Stress Index Short Form (PSI-sf) | At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline) | 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). |
| Brief Infant-Toddler Social Emotional Assessment (BITSEA) | At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline) | 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. |
Countries
Finland
Contacts
PRINCIPAL_INVESTIGATORPaula Virtala, PhD
University of Helsinki
Outcome results
None listed