Language Development Deficits and Early Interactive Music Intervention
- Conditions
- Dyslexia, DevelopmentalLanguage DevelopmentLanguage Development Disorders
- Interventions
- Behavioral: Music interventionBehavioral: Circus intervention
- Registration Number
- NCT06261307
- Lead Sponsor
- University of Helsinki
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Music intervention Music intervention 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. Circus intervention Circus intervention 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.
- Primary Outcome Measures
Name Time Method 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
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)
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 Outcome Measures
Name Time Method 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
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).
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)
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.
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.
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
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, 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, 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
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.
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.
Trial Locations
- Locations (1)
University of Helsinki
🇫🇮Helsinki, Finland