Clinical trial NCT06332144: Predicting Language and Literacy Growth in Children With ASD Using Statistical Learning
Official title: Predicting Language and Literacy Growth in Children With ASD Using Statistical Learning
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Language Development
Literacy
Keywords: Statistical Learning
Implicit Learning
Neuroimaging
Autism Spectrum Disorder
Language Development
Reading Development
fMRI
Lead sponsor: Northeastern University
Sponsor class: OTHER
Collaborators: name: University of Delaware
name: Boston University
name: Cornell University
First posted: 2024-03-27
Enrollment: 50
Sex: ALL
Minimum age (years): 72
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this observational study is to test a reciprocal relationship between statistical learning and the development of language and literacy in first-graders with autism and their non-autistic peers. The main questions it aims to answer are:

1. whether children's statistical learning abilities can predict their long-term improvement of language and literacy skills in school;
2. how children's brains automatically learn patterns from speech and prints;
3. whether children's learning in the lab reflects the language patterns they have learned over the years from their native language.

First-grade students will participate in the study twice across three months.

During Time 1, children will complete

* a battery of language, reading, and cognitive assessments
* a series of computer-based statistical learning games both inside and outside of functional MRI scanner.

During Time 2, children will complete a battery of language and reading assessments to detect the growth in three months.

Researchers will compare the autistic and the non-autistic groups to see if statistical learning plays a similar or different role in predicting children's language and literacy growth.

Detailed description: In this one-year R56 project, the investigators will design a mini-longitudinal project to test how children's linguistic statistical learning predicts their growth in spoken and written language in three months. The investigators predict that weaker linguistic statistical learning underlies the exacerbation of language and literacy delay in children with ASD. In this project, the investigators will gamify an existing study protocol, which has led to promising discoveries motivating the original R01 proposal. With an enriched platform, the investigators expect a low attrition rate (\<10%) and few missing data (\>90% task completion rate) in this longitudinal sample of six-year-olds both with and without ASD, matched on age and sex ratio. This project will lead to critical feasibility and preliminary data to support the key hypotheses of all three aims. Due to a shortened timeline, the investigators plan to recruit 25 children per group, sampled from a diverse population, to ensure the team's capacity for a three-month follow-up session before the end of a school year.

Aim 1: Establish the longitudinal relationships between SL and language/literacy development in both TD and ASD. In this aim, the investigators will evaluate the role of SL in both concurrent and the growth of language/literacy skills assessed in three months during the school year. The investigators expect that linguistic SL (embedded pattern learning of syllables and letters) is associated with concurrent language and literacy skills and will prove to be crucial predictors of growth in language and literacy skills in both groups. Given the small sample size in this one-year project, the investigators will build prediction models both across the two groups and within each group. Sex, concurrent language and reading skills, and nonverbal IQ will be included as key covariables.

Aim 2: Determine the longitudinal relationships between neural bases of SL and developing language networks in the brains of children with ASD. In this aim, the investigators will test whether altered brain functions during linguistic SL are related to poorly functioning language networks (language comprehension and phonological working memory), defined within each individual child. The investigators will also examine whether neural bases of linguistic SL predict future language and literacy development in children with ASD. Participants from Aim 1 will complete linguistic SL tasks and two well-validated language tasks in the fMRI scanner at Time 1. The investigators expect to find reduced engagement of language networks during SL in children with ASD and to provide a neurobiological explanation for the cascading effect impaired linguistic SL casts on future language development.

Aim 3: Test whether linguistic SL is a proxy for children's sensitivity to real-world language statistics. The investigators ask whether the specific weakness in linguistic SL in ASD generalizes to real-world language statistics using serial recall tasks, a well-validated instrument for individuals' sensitivity to native-language statistical patterns. The same participants in the previous aims will complete a phonological and an orthographic serial recall task containing both high- and low-frequency English bigrams/trigrams at Time 1 and Time 2. The investigators predict that these tasks will be associated with children's linguistic SL performance in Aim 1 and children's linguistic SL at earlier times will predict the future growth of sensitivity to natural language statistics. These findings will establish the critical link between linguistic SL and children's natural language skills.

Eligibility criteria: Inclusion Criteria:

* current first grader (6;0 - 7;6)
* Geographically located within the Greater Boston Metropolitan Area
* Native English speakers
* Normal hearing
* Normal or corrected vision

Inclusion criteria for children with ASD (N = 25):

* Children with a professional diagnosis of autism according to expert clinical judgment
* Capable of speaking sentences with three or more words
* Social Communication Parent Questionnaire score \> 15
* Autism diagnosis confirmed by ADOS

Inclusion criteria for typically developing controls (N = 25):

* Neurotypical: with no known cognitive, neurological, or psychiatric disorders
* Social Communication Parent Questionnaire score \< 11
* Receive a score within 1 SD of the population mean for age on all assessments.

Exclusion Criteria:

* non-native speakers of English
* More than 30 hours of exposure to a language other than English per week
* history of brain injuries and head injuries
* intellectual disability, mutism, motor delay, or developmental coordination disorder
* metal in body
* claustrophobic
* history of prior neurosurgical procedure
* substance abuse
* signs of increased intracranial pressure

Primary outcomes:
measure: Language Composite Score
timeFrame: At each of the two measuring time points during the school year of the first grade with three months apart over a 40-minute teleassessment session
measure: Reading Composite Score
timeFrame: At each of the two measuring time points during the school year of the first grade with three months apart over a 40-minute teleassessment session
measure: Language/Literacy Disorder Status
timeFrame: At the first visit during the school year of the first grade over a 40-minute teleassessment session
measure: Neural similarity between language and statistical learning tasks
timeFrame: At the first visit during the school year of the first grade over a two-hour MRI session
measure: Orthographic statistical sensitivity
timeFrame: At each of the two measuring time points during the school year of the first grade with three months apart
measure: Phonological statistical sensitivity
timeFrame: At each of the two measuring time points during the school year of the first grade with three months apart
Secondary outcomes:
measure: Linguistic SL composite scores
timeFrame: At each of the two measuring time points during the school year of the first grade with three months apart
measure: Neural sensitivity to statistical regularities during the statistical learning tasks
timeFrame: At the first visit during the school year of the first grade over a two-hour MRI session
Other outcomes:
measure: Neural activation to statistical regularities during the language tasks
timeFrame: At the first visit during the school year of the first grade over a two-hour MRI session
Locations:
city: Boston
country: United States
facility: Northeastern University
state: Massachusetts
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
affiliation: Northeastern University
name: Zhenghan Qi, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ozernov-Palchik O, Qi Z, Beach SD, Gabrieli JDE. Intact procedural memory and impaired auditory statistical learning in adults with dyslexia. Neuropsychologia. 2023 Sep 9;188:108638. doi: 10.1016/j.neuropsychologia.2023.108638. Epub 2023 Jul 28.
citation: Hu A, Kozloff V, Owen Van Horne A, Chugani D, Qi Z. Dissociation Between Linguistic and Nonlinguistic Statistical Learning in Children with Autism. J Autism Dev Disord. 2024 May;54(5):1912-1927. doi: 10.1007/s10803-023-05902-1. Epub 2023 Feb 7.
citation: O'Brien AM, Perrachione TK, Wisman Weil L, Sanchez Araujo Y, Halverson K, Harris A, Ostrovskaya I, Kjelgaard M, Kenneth Wexler, Tager-Flusberg H, Gabrieli JDE, Qi Z. Altered engagement of the speech motor network is associated with reduced phonological working memory in autism. Neuroimage Clin. 2023;37:103299. doi: 10.1016/j.nicl.2022.103299. Epub 2022 Dec 23.
citation: Schneider JM, Hu A, Legault J, Qi Z. Measuring Statistical Learning Across Modalities and Domains in School-Aged Children Via an Online Platform and Neuroimaging Techniques. J Vis Exp. 2020 Jun 30;(160):10.3791/61474. doi: 10.3791/61474.