Autism Spectrum DisorderPLAUSLNCT06332144
Predicting Language and Literacy Growth in Children With ASD Using Statistical Learning
A study testing Structural vs. Random sequences of stimuli, Intact vs. Degraded speech and Repeating 5-syllable nonwords or 2-syllable nonwords in people with Autism Spectrum Disorder and Language Development, run by Northeastern University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 72 to 90 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Language Development, Literacy
- What is being tested?
- Structural vs. Random sequences of stimuli, Intact vs. Degraded speech and Repeating 5-syllable nonwords or 2-syllable nonwords
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jan 2024to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 72 to 90 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 13Show fewer
- 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.
Who cannot join
- 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
Show all 9Show fewer
- history of prior neurosurgical procedure
- substance abuse
- signs of increased intracranial pressure
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northeastern University
Boston, Massachusetts, 02115
Boston University
Boston, Massachusetts, 02215
About this study
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:
- whether children's statistical learning abilities can predict their long-term improvement of language and literacy skills in school;
- how children's brains automatically learn patterns from speech and prints;
- whether children's learning in the lab reflects the language patterns they have learned over the years from their native language.
Read more
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder, Language Development, Literacy
- Being tested
- 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.
- Keywords
- Statistical Learning, Implicit Learning, Neuroimaging, Autism Spectrum Disorder, Language Development, Reading Development, fMRI
- Medical subject headings
- Autism Spectrum Disorder, Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structural vs. Random sequences of stimuliBehavioural
Participants will see or listen to sequences of sounds and images either in a structured condition or a random condition.
Intact vs. Degraded speechBehavioural
Participants will listen to an audiobook "Alice in Wonderland" in the MRI scanner. The speech is either intact or degraded.
Repeating 5-syllable nonwords or 2-syllable nonwordsBehavioural
Participants will listen to nonwords (either 5-syllable or 2-syllable) and then repeat them as accurately as possible in the MRI scanner.
Recall letter or syllable strings that either contain highly frequent bigram/trigram items or infrequent items according to English Corpus data.Behavioural
Participants will read (orthographic serial recall) or listen to (phonological serial recall) strings.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Structural vs. Random sequences of stimuli; Behavioral: Intact vs. Degraded speech; Behavioral: Repeating 5-syllable nonwords or 2-syllable nonwords; Behavioral: Recall letter or syllable strings that either contain highly frequent bigram/trigram items or infrequent items according to English Corpus data. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
The linguistic SL score will be the average of the letter and the syllable composite scores after averaging across the normalized scores of RT slope, accuracy, and serial recall.
Measured: 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
The magnitude of BOLD responses to structured vs. random conditions in the syllable and the letter statistical learning tasks.
Measured: At the first visit during the school year of the first grade over a two-hour MRI session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start13 Jan 2024
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Delaware, Boston University, Cornell University
- Responsible party
- Sponsor
- Investigators
- Zhenghan Qi, MD/PhD, Principal investigator, Northeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332144
- Sponsor's protocol ID
- 1R56DC020208-01A1
- Acronym
- PLAUSL
- Status last verified
- Dec 2025
- First submitted
- 5 Mar 2024
- Last updated
- 22 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 37516235Hu 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.
PubMed 36749457O'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.
PubMed 36584426Schneider 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.
PubMed 32716372
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Language and Literacy Growth in Children With ASD Using Statistical Learning
- ClinicalTrials.gov ID
- NCT06332144
- Acronym / sponsor ID
- PLAUSL / 1R56DC020208-01A1
- Conditions
- Autism Spectrum Disorder, Language Development, Literacy
- Keywords
- Statistical Learning, Implicit Learning, Neuroimaging, Autism Spectrum Disorder, Language Development, Reading Development, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Northeastern UniversityUniversity, hospital or other
- Collaborators
- University of Delaware, Boston University, Cornell University
- Study start
- 13 Jan 2024 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- whether children's statistical learning abilities can predict their long-term improvement of language and literacy skills in school;
- how children's brains automatically learn patterns from speech and prints;
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled participants | Experimental | Behavioral: Structural vs. Random sequences of stimuli, Behavioral: Intact vs. Degraded speech, Behavioral: Repeating 5-syllable nonwords or 2-syllable nonwords, Behavioral: Recall letter or syllable strings that either contain highly frequent bigram/trigram items or infrequent items according to English Corpus data.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 |
Who may qualify
- Ages
- 72 to 90 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- current first grader (6;0 - 7;6)
- Geographically located within the Greater Boston Metropolitan Area
- Native English speakers
- Normal hearing
- Normal or corrected vision
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structural vs. Random sequences of stimuliParticipants will see or listen to sequences of sounds and images either in a structured condition or a random condition. | Behavioural | Enrolled participants |
| Intact vs. Degraded speechParticipants will listen to an audiobook "Alice in Wonderland" in the MRI scanner. The speech is either intact or degraded. | Behavioural | Enrolled participants |
| Repeating 5-syllable nonwords or 2-syllable nonwordsParticipants will listen to nonwords (either 5-syllable or 2-syllable) and then repeat them as accurately as possible in the MRI scanner. | Behavioural | Enrolled participants |
| Recall letter or syllable strings that either contain highly frequent bigram/trigram items or infrequent items according to English Corpus data.Participants will read (orthographic serial recall) or listen to (phonological serial recall) strings. | Behavioural | Enrolled participants |
Primary outcome
Language Composite Score
Time frame: 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
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.
Reading Composite Score
Time frame: 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
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.
Language/Literacy Disorder Status
Time frame: At the first visit during the school year of the first grade over a 40-minute teleassessment session
The binary status is determined by children's TILLS Identification core scores
Neural similarity between language and statistical learning tasks
Time frame: At the first visit during the school year of the first grade over a two-hour MRI session
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.
Orthographic statistical sensitivity
Time frame: At each of the two measuring time points during the school year of the first grade with three months apart
The difference in recall accuracy of bigrams/trigrams between the high- vs. low-frequency items in the orthographic serial recall task.
Phonological statistical sensitivity
Time frame: At each of the two measuring time points during the school year of the first grade with three months apart
The difference in recall accuracy of bigrams/trigrams between the high- vs. low-frequency items in the phonological serial recall task.
2 secondary outcomes
Linguistic SL composite scores
Time frame: 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
Time frame: At the first visit during the school year of the first grade over a two-hour MRI session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Background: PubMed 37516235Ozernov-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.
- Background: PubMed 36749457Hu 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.
- Background: PubMed 36584426O'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.
- Background: PubMed 32716372Schneider 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.
- PLAUSL Project WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Autism Spectrum Disorder
Recruiting
Strategies for Toddler ASD With Remote-therapy (STAR) Model for ASD
Autism Spectrum Disorder, Therapy
Recruiting
Smith Magenis Syndrome and Autism Spectrum Disorders
Smith-Magenis Syndrome, Autism Spectrum Disorder
Active, not recruitingPhase 1
Psilocybin for Treatment-Resistant Depression in Autism
Treatment Resistant Depression, Autism Spectrum Disorder
RecruitingPhase 2
TRIal of PPF3 vs. PlaCEbo in the TReatment of Children and AdolescenTs With NeurOdeveloPmental DisorderS
Autism Disorder
Not yet recruitingObservational study
EEG As a Genetic Selection Lever in Autism Spectrum Disorder
Autism Spectrum Disorder (ASD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhenghan Qi, MD/PhD principal investigator
Northeastern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structural vs. Random sequences of stimuli, Intact vs. Degraded speech and Repeating 5-syllable nonwords or 2-syllable nonwords in people with Autism Spectrum Disorder and Language Development, run by Northeastern University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Language Composite Score (time frame: 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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06332144, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.