Language Development Deficits and Early Interactive Music Intervention

Language Development Clinical Trial

— BusyBaby  

Official title:

Language Development Deficits and Early Interactive Music Intervention - a Randomized Controlled Trial (BusyBaby)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06261307
• Other study ID #: 13462111
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2024
• Est. completion date: March 2027

Study information

• Verified date: April 2024
• Source: University of Helsinki
• Contact: Paula Virtala, PhD
• Phone: 408446907
• Email: paula.virtala[@]helsinki.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2027
• Est. primary completion date: March 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Months to 12 Months

Eligibility

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.

Related Conditions & MeSH terms

• Dyslexia
• Dyslexia, Developmental
• Language Development
• Language Development Disorders

Intervention

Behavioral:
• Music intervention
Group intervention focusing on musical activities
• Circus intervention
Group intervention focusing on acrobatics and circus activities

Locations

Country	Name	City	State
Finland	University of Helsinki	Helsinki

Sponsors (6)

Lead Sponsor	Collaborator
University of Helsinki	Academy of Finland, Folkhälsan Research Center, Karolinska Institutet, University of Jyvaskyla, University of Turku

Country where clinical trial is conducted

Finland, 

References & Publications (2)

Kujala T, Sihvonen AJ, Thiede A, Palo-Oja P, Virtala P, Numminen J, Laasonen M. Voxel and surface based whole brain analysis shows reading skill associated grey matter abnormalities in dyslexia. Sci Rep. 2021 May 25;11(1):10862. doi: 10.1038/s41598-021-89317-x. — View Citation

Paula V, Vesa P, Anastasia G, Anja T, Laurel J T, Teija K. Beneficial effects of a music listening intervention on neural speech processing in 0-28-month-old children at risk for dyslexia. Dev Sci. 2023 Sep;26(5):e13426. doi: 10.1111/desc.13426. Epub 2023 Jun 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Parental dyslexia status (dyslexia - no dyslexia)	Parental dyslexia status confirmed with a recent (< 5 years) clinical statement or a test battery including a clinical interview and a standardized questionnaire, described, e.g. in Kujala et al. (2021). Parental dyslexia is an inclusion criterion for the risk group participants, and it will be evaluated from all parents who suspect that they have dyslexia.	At enrollment to the study (before the children are accepted to the study and randomized)
Other	Allele groupings for dyslexia susceptibility genes	Allele groupings in single nucleotide polymorphisms (SNPs) of susceptibility genes associated with language, reading, and developmental dyslexia, analyzed from DNA samples and used for forming subgroups to study associations to Outcome measures 1-17. After data collection ends for the outcome measures, 5-10 most relevant SNPs are chosen according to the most recent research literature.	At baseline
Other	Gross and fine motor development	Ages of reaching basic milestones in gross motor development and fine motor development, as reported by parents in a background questionnaire	At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
Other	Bayley Scales III Motor scale	Fine and gross motor development of the child as evaluated with the Motor scale of the standardized Bayley Scales III battery (Bayley, 2006).The range of scores for the Fine motor development scale is 0-66 and for the Gross motor development scale, 0-72, higher scores reflecting better motor abilities.	At 6 months (post-intervention) and at 1-year follow-up (1.5 years from baseline)
Other	Mismatch response (MMR) music, amplitude	Amplitude (in microvolts) of mismatch responses to auditory deviants in a musical oddball paradigm recorded with electroencephalogram (EEG) from a fronto-central region-of-interest	At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
Other	Mismatch response (MMR) music, latency	Peak latency (in milliseconds) of mismatch responses to auditory deviants in a musical oddball paradigm recorded with electroencephalogram (EEG) from a fronto-central region-of-interest	At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
Other	Mismatch response (MMR) music, laterality	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 auditory deviants in a musical oddball paradigm recorded with electroencephalogram (EEG) from a fronto-central region-of-interest	At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
Other	Obligatory event-related potential (ERP) music, amplitude	Amplitude (in microvolts) of obligatory event-related potentials (ERPs) to repeating musical stimuli in an oddball paradigm recorded with electroencephalogram (EEG) from a fronto-central region-of-interest	At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
Other	Obligatory event-related potential (ERP) music, latency	Peak latency (in milliseconds) of obligatory event-related potentials (ERPs) to repeating musical stimuli in an oddball paradigm recorded with electroencephalogram (EEG) from a fronto-central region-of-interest	At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
Other	Obligatory event-related potential (ERP) music, laterality	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 musical stimuli in an oddball paradigm recorded with electroencephalogram (EEG) from a fronto-central region-of-interest at left and right hemisphere	At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
Other	Music test scores (three parts of MMBB-MB)	A custom-made musicality test battery, i.e., the Music, Mind, Body, and Brain Music Battery (MMBB-MB) measures core domains of music cognition. The children (with the help of their parents, according to their age-appropriate abilities) are asked 1) to tap with their finger in unpaced (spontaneous) and paced (to metronome and music) conditions, 2) to perform whole-body movements in unpaced and paced conditions, and 3) to sing along models or spontaneously single tones, tone sequences, and a familiar song.	At 1-year follow-up (1.5 years from baseline)
Other	Music-related activities	Frequency and intensity of child's music-related activities as reported by parents in a background questionnaire (incl. joint singing, dancing, moving to music and playing instruments at home, music listening and exposure to music at home, music-related hobbies)	At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
Other	Musical background of parents	Parents' musical background (incl. preferences, training, and listening habits) self-reported in a background questionnaire	At baseline
Other	Home literacy	Quality of home literacy environment (incl. amount of reading in parents, amount of reading aloud to the child, amount of children's and adults' books at home, frequency of library visits, and audio book listening) as reported by parents in a background questionnaire	At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
Other	Multilingualism	The degree of multilingualism of the child and their environment (incl. native languages of family members and languages spoken to the child at home, at daycare, and at other environments) as reported by parents in a background questionnaire	At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
Other	Screen time	Total weekly screen time of the child in hours as reported by parents in a background questionnaire	At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
Primary	Infant-Toddler Checklist (ITC)	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.	At baseline and at 6 months (post intervention)
Primary	MacArthur-Bates Communicative Development Inventory (MCDI) 8-16mo	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)	At baseline and at 6 months (post intervention)
Primary	Mismatch response (MMR) speech, amplitude	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	At baseline and at 6 months (post intervention)
Primary	Mismatch response (MMR) speech, latency	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	At baseline and at 6 months (post intervention)
Primary	Mismatch response (MMR) speech, laterality	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	At baseline and at 6 months (post intervention)
Primary	Obligatory event-related potential (ERP) speech, amplitude	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	At baseline and at 6 months (post intervention)
Primary	Obligatory event-related potential (ERP) speech, latency	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	At baseline and at 6 months (post intervention)
Primary	Obligatory event-related potential (ERP) speech, laterality	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	At baseline and at 6 months (post intervention)
Secondary	Infant-Toddler Checklist (ITC) follow-up	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.	At 1-year follow-up (1.5 years from baseline)
Secondary	MacArthur-Bates Communicative Development Inventory (MCDI) 16-30mo follow-up	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)	At 1-year follow-up (1.5 years from baseline)
Secondary	Mismatch response (MMR) speech, amplitude follow-up	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	At 1-year follow-up (1.5 years from baseline)
Secondary	Mismatch response (MMR) speech, latency follow-up	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	At 1-year follow-up (1.5 years from baseline)
Secondary	Mismatch response (MMR) speech, laterality follow-up	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	At 1-year follow-up (1.5 years from baseline)
Secondary	Obligatory event-related potential (ERP) speech, amplitude follow-up	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	At 1-year follow-up (1.5 years from baseline)
Secondary	Obligatory event-related potential (ERP) speech, latency follow-up	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	At 1-year follow-up (1.5 years from baseline)
Secondary	Obligatory event-related potential (ERP) speech, laterality follow-up	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	At 1-year follow-up (1.5 years from baseline)
Secondary	Reynell Developmental Language Scales III (RDLS-III)	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.	At 6 months (post intervention) and at 1-year follow-up (1.5 years from baseline)
Secondary	Infant Behavior Questionnaire Revised short form (IBQ-R-sf)	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.	At baseline
Secondary	Early Childhood Behavior Questionnaire short form (ECBQ-sf)	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.	At 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
Secondary	Parenting Stress Index Short Form (PSI-sf)	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).	At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)
Secondary	Brief Infant-Toddler Social Emotional Assessment (BITSEA)	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.	At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)