NCT06332144

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:

  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 27, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

1.6 years

First QC Date

March 5, 2024

Last Update Submit

December 18, 2025

Conditions

Keywords

Statistical LearningImplicit LearningNeuroimagingAutism Spectrum DisorderLanguage DevelopmentReading DevelopmentfMRI

Outcome Measures

Primary Outcomes (6)

  • Language Composite Score

    The concurrent language skills will be computed by averaging each child's standardized scores across the TILLS language subsets and NIH Toolbox Picture Vocab. The composite score will range between 50 and 150. The higher score, the better language skills.

    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

  • Reading Composite Score

    The concurrent reading skills will be computed by averaging across WRMT-III subtests, NIH Toolbox oral reading recognition. The composite score will range between 50 and 150. The higher score, the better reading skills.

    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

  • Language/Literacy Disorder Status

    The binary status is determined by children's TILLS Identification core scores

    At the first visit during the school year of the first grade over a 40-minute teleassessment session

  • Neural similarity between language and statistical learning tasks

    The multivoxel similarity between language processing (or phonological working memory) tasks and the statistical learning task in subject-specific language (or phonological working memory) brain regions.

    At the first visit during the school year of the first grade over a two-hour MRI session

  • Orthographic statistical sensitivity

    The difference in recall accuracy of bigrams/trigrams between the high- vs. low-frequency items in the orthographic serial recall task.

    At each of the two measuring time points during the school year of the first grade with three months apart

  • Phonological statistical sensitivity

    The difference in recall accuracy of bigrams/trigrams between the high- vs. low-frequency items in the phonological serial recall task.

    At each of the two measuring time points during the school year of the first grade with three months apart

Secondary Outcomes (2)

  • Linguistic SL composite scores

    At each of the two measuring time points during the school year of the first grade with three months apart

  • Neural sensitivity to statistical regularities during the statistical learning tasks

    At the first visit during the school year of the first grade over a two-hour MRI session

Other Outcomes (1)

  • Neural activation to statistical regularities during the language tasks

    At the first visit during the school year of the first grade over a two-hour MRI session

Study Arms (1)

Enrolled participants

EXPERIMENTAL

Structural vs. Random sequences of stimuli; Intact vs. Degraded speech; Repeating 5-syllable nonwords or 2-syllable nonwords; Recall letter or syllable strings that either contain highly frequent bigram/trigram items or infrequent items according to English Corpus data

Behavioral: Structural vs. Random sequences of stimuliBehavioral: Intact vs. Degraded speechBehavioral: Repeating 5-syllable nonwords or 2-syllable nonwordsBehavioral: Recall letter or syllable strings that either contain highly frequent bigram/trigram items or infrequent items according to English Corpus data.

Interventions

Participants will listen to an audiobook "Alice in Wonderland" in the MRI scanner. The speech is either intact or degraded.

Enrolled participants

Participants will listen to nonwords (either 5-syllable or 2-syllable) and then repeat them as accurately as possible in the MRI scanner.

Enrolled participants

Participants will see or listen to sequences of sounds and images either in a structured condition or a random condition.

Enrolled participants

Participants will read (orthographic serial recall) or listen to (phonological serial recall) strings.

Enrolled participants

Eligibility Criteria

Age72 Months - 90 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Northeastern University

Boston, Massachusetts, 02115, United States

Location

Boston University

Boston, Massachusetts, 02215, United States

Location

Related Publications (4)

  • 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.

    PMID: 37516235BACKGROUND
  • 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.

    PMID: 36749457BACKGROUND
  • 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.

    PMID: 36584426BACKGROUND
  • 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.

    PMID: 32716372BACKGROUND

Related Links

MeSH Terms

Conditions

Autism Spectrum DisorderLiteracy

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersCommunicationBehavior

Study Officials

  • Zhenghan Qi, MD/PhD

    Northeastern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2024

First Posted

March 27, 2024

Study Start

January 13, 2024

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

December 22, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

The demographic and behavioral information will be made available in the form of a comma delimited text file and a code book. We will disguise individuals' identities by redacting birthdates and date of examination from the available records and by replacing names with coded alphanumeric values. When permission is granted, we will deposit all raw, de-identified behavioral and neuroimaging data into the National Institute of Mental Health Data Archive (NDA). The fMRI data will be uploaded to a public repository to improve meta-analyses and data-sharing (NeuroVault, OpenNeuro). To protect the privacy and confidentiality of the participants, raw video or audio files will not be shared outside of the research team. We do not commit to processing additional data beyond our own needs for the purpose of sharing. Any data we have processed we are willing to share. We will submit electronic versions of all accepted manuscripts to the NIH National Library of Medicine PubMed database.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
The data will be made available to other users within 12 months of the final data point being collected or at the time of an associated publication, whichever comes first.
Access Criteria
All research participants will be consented for broad data sharing. To protect the privacy and confidentiality of the participants, raw video or audio files will not be shared outside of the research team. We do not commit to processing additional data beyond our own needs for the purpose of sharing. Any data we have processed we are willing to share. To request access of the data, researchers will use the standard processes at NDA, and the NDA Data Access Committee will decide which requests to grant. The standard NDA data access process allows access for one year and is renewable. The NDA GUID tool allows researchers to aggregate data from the same research participant without different laboratories having to share personally identifiable information about that research participant. The NDA data dictionaries do not permit personally identifiable information to be shared. NDA maintains a Certificate of Confidentiality.

Locations