Language Development Deficits and Early Interactive Music Intervention

Browse trials for

• Dyslexia 127
• Language Development Disorders 121

Keywords

• Event-related potentials
• Music intervention
• Brain development
• Speech processing

Dyslexia

127 studies on the registry are indexed under Dyslexia; 27 are open to participants now.

This study's planned enrollment of 200 is above the median of 71 across 106 interventional studies indexed under Dyslexia.

Lead sponsor

University of Helsinki is the lead sponsor of 133 studies on the registry; 19 are open to participants now.

Study arms

• Experimental
  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.

  Behavioral: Music intervention

• Active comparator
  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.

  Behavioral: Circus intervention

Interventions

• BehavioralMusic intervention

  Group intervention focusing on musical activities

• BehavioralCircus intervention

  Group intervention focusing on acrobatics and circus activities

Primary outcomes

1. 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.

   Time frame: At baseline and at 6 months (post intervention)

2. 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)

   Time frame: At baseline and at 6 months (post intervention)

3. 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

   Time frame: At baseline and at 6 months (post intervention)

4. 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

   Time frame: At baseline and at 6 months (post intervention)

5. 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

   Time frame: At baseline and at 6 months (post intervention)

6. 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

   Time frame: At baseline and at 6 months (post intervention)

7. 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

   Time frame: At baseline and at 6 months (post intervention)

8. 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

   Time frame: At baseline and at 6 months (post intervention)

Secondary outcomes

1. 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.

   Time frame: At 1-year follow-up (1.5 years from baseline)

2. 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)

   Time frame: At 1-year follow-up (1.5 years from baseline)

3. 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

   Time frame: At 1-year follow-up (1.5 years from baseline)

4. 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

   Time frame: At 1-year follow-up (1.5 years from baseline)

5. 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

   Time frame: At 1-year follow-up (1.5 years from baseline)

6. 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

   Time frame: At 1-year follow-up (1.5 years from baseline)

7. 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

   Time frame: At 1-year follow-up (1.5 years from baseline)

8. 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

   Time frame: At 1-year follow-up (1.5 years from baseline)

9. 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.

   Time frame: At 6 months (post intervention) and at 1-year follow-up (1.5 years from baseline)

10. 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.

    Time frame: At baseline

11. 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.

    Time frame: At 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)

12. 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).

    Time frame: At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)

13. 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.

    Time frame: At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)

Other outcomes

1. 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.

   Time frame: At enrollment to the study (before the children are accepted to the study and randomized)

2. 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.

   Time frame: At baseline

3. 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

   Time frame: At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)

4. 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.

   Time frame: At 6 months (post-intervention) and at 1-year follow-up (1.5 years from baseline)

5. 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

   Time frame: At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)

6. 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

   Time frame: At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)

7. 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

   Time frame: At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)

8. 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

   Time frame: At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)

9. 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

   Time frame: At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)

10. 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

    Time frame: At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)

11. 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.

    Time frame: At 1-year follow-up (1.5 years from baseline)

12. 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)

    Time frame: At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)

13. Musical background of parents

    Parents' musical background (incl. preferences, training, and listening habits) self-reported in a background questionnaire

    Time frame: At baseline

14. 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

    Time frame: At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)

15. 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

    Time frame: At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)

16. Screen time

    Total weekly screen time of the child in hours as reported by parents in a background questionnaire

    Time frame: At baseline, 6 months (post-intervention), and 1-year follow-up (1.5 years from baseline)

Publications

• 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. PubMed 37350469 ↗
• 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. PubMed 34035329 ↗
• Virtala P, Aquilino B, Nie P, Navarrete-Arroyo S, Stolt S, Leutonen K, Lauronen M, Kujala T. Language development deficits and early interactive music intervention (BusyBaby): protocol description of a double-blind randomized controlled trial on the effectiveness of music on language development in infancy. Front Psychol. 2026 Jan 5;16:1699558. doi: 10.3389/fpsyg.2025.1699558. eCollection 2025. PubMed 41561604 ↗

Individual participant data

Plan to share: No