SpeechNCT07472829
Research on Speech Development Trajectories and Predictive Models in Children With Autism Spectrum Disorder
An observational study of Speech and Autism Spectrum Disorder (ASD), run by Children's Hospital of Chongqing Medical University.
Trial summary
Recent studies indicate that children with ASD have a significantly higher risk of co-occurring speech sound disorders than typically developing children. Early atypical speech development may be a critical yet overlooked bottleneck hindering their language improvement. Read more about this study
- Who is it for?
- Ages 18 to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Speech, Autism Spectrum Disorder (ASD)
- What is being tested?
- Approaches to ASD social intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2026to 31 Dec 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 60 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: TD group
Who may be able to join
- Diagnosed as typically developing children by two or more associate chief physicians.
- Gender- and age-matched to the ASD group.
- Participants whose native language is Chinese.
Who cannot join
- Participants not meeting the age requirement.
- Presence of orofacial motor and swallowing dysfunction.
- Hearing impairment.
- Participants whose native language isn't Chinese.
- Neurological disorders (such as encephalitis or seizures) and comorbid psychiatric disorders.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Recent studies indicate that children with ASD have a significantly higher risk of co-occurring speech sound disorders than typically developing children. Early atypical speech development may be a critical yet overlooked bottleneck hindering their language improvement. Given the unique phonetic features of Mandarin, it is essential to investigate speech development in Mandarin-speaking children with ASD. This study aims to construct developmental trajectories and establish early identification and prognosis prediction models for this population.
Read the detailed description
- Procedures. This study plans to enroll 60 children with autism spectrum disorder (ASD group) and 60 typically developing children (TD group), aged 18-60 months, matched by age and sex. At baseline, both groups will undergo assessments of development, language, and parent-child interaction, as well as fNIRS; the ASD group will additionally receive clinical diagnostic evaluations. Subsequently, a one-year follow-up will be conducted, with both groups completing language and parent-child interaction assessments at 3, 6, 9, and 12 months, and undergoing repeated developmental and fNIRS evaluations at the final 12-month visit.
- Demographic questionnaire and clinical data. The demographic questionnaire is completed by the child's primary caregiver, detailing child's name, gender, date of birth, height, weight, heart rate. Clinical data will be ascertained from the medical records, including information about DSM-5 diagnosis and comorbid conditions.
- Sample size. This study ultimately determined a sample size of 120 participants (60 in the ASD group and 60 in the TD group). The estimation was based on the minimum sample size required to analyze the "group × time" interaction effect using a mixed-effects model (88 participants, achieving 85% power), and fully considered the following factors: ① Meeting the analytical requirements for both the main effects of group and time; ② The need to increase the sample size to 110 participants if multiple comparison corrections (Bonferroni correction, α=0.0083) are applied to the six speech indicators; ③ Considering practical operational challenges such as the long follow-up period, multiple repeated measurements, and anticipated dropout rates, the sample was ultimately expanded to 120 participants to ensure the robustness of the study.
- Statistical analysis. SPSS 25.0 software (SPSS Inc) was used for statistical analysis for the scale data, The speech development trajectories of the two groups can be analyzed using longitudinal methods such as mixed-effects models. Repeated measures ANOVA will compare speech characteristics between the ASD and TD groups at five time points (baseline, 3, 6, 9, and 12 months). Correlation analysis (Pearson or Spearman, depending on normality) will assess the relationship between speech development and core ASD symptoms. ANOVA/MANOVA will examine group differences in speech perception tasks, and exploratory factor analysis will identify underlying factors influencing speech perception.All statistical analyses were conducted with a statistical threshold P-value of <0.05. The data collected through fNIRS will be performed via NirSpark analysis software.
- Ethical matters and data protection. The children participated in the study will sign the informed consent (obtained from the guardian). And this study was approved by the local ethics committee. children's name will be abbreviated and the research data will be assigned a code then to provide to the researcher. The authorization from parents on the children's health information remains valid until the study is completed. After that, researchers will delete private information from the study record.
- Conditions
- Speech, Autism Spectrum Disorder (ASD)
- Being tested
- Approaches to ASD social intervention
- Medical subject headings
- Speech, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Approaches to ASD social interventionBehavioural
The intervention methods for children in the ASD group will be documented in detail (through telephone or online follow-ups, based on parental reports, with records including the location, time, frequency, and main content of the interventions); children in the TD group did not receive any intervention.
| Study group | Role | What they receive |
|---|---|---|
| ASD group | Inclusion criteria:
Diagnosed by two or more associate chief physicians using the DSM-5 diagnostic criteria.
Participants aged between 18 and 60 months. Participants with a vocabulary size ranging from 0 to 50 words, as assessed using the Chinese Communicative Development Inventory.
Participants whose native language is Chinese.
Exclusion criteria:
Participants not meeting the age requirement. Presence of orofacial motor and swallowing dysfunction. Hearing impairment. Participants whose native language isn't Chinese. Neurological disorders (such as encephalitis or seizures) and comorbid psychiatric disorders. Receives: Behavioral: Approaches to ASD social intervention | |
| TD group | Inclusion Criteria: Diagnosed as typically developing children by two or more associate chief physicians. Gender- and age-matched to the ASD group. Participants whose native language is Chinese. Exclusion Criteria: Participants not meeting the age requirement. Presence of orofacial motor and swallowing dysfunction. Hearing impairment. Participants whose native language isn't Chinese. Neurological disorders (such as encephalitis or seizures) and comorbid psychiatric disorders. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The language ability of ASD group and TD group by Dream-it
The participants will be assessed using the Dream-it, which consists of two separate scales developed for children aged 0-18 months and 18-36 months, respectively. The assessment is conducted via parent report and completed on an iPad. The evaluation covers four domains: language comprehension, language expression, cognitive play, and social communication.The researchers will calculate the participants' scale scores across four dimensions and compare them at different time points.
Measured: Baseline enrollment；3 months ,6 months ,9 months and 12 months after follow-up
The language ability of ASD group and TD group by free-play session with one parent
The participants will be engage in a 15-minute semi-structured free-play session with one parent, which will be video-recorded for later coding of behavioral and vocalization measures. The investigators will collect the participant's naturalistic language. Indicators such as the diversity of syllables, the number of vowels, and the number of consonants will be calculated and compared at various time points.
Measured: Baseline enrollment; 3 months, 6 months, 9 months and 12 months after follow-up
Secondary outcomes (3)
The changes in degree of ASD disorder by Autism Diagnostic Observation Schedule-2
The participants in ASD group will be accepted the ADOS assessment.The Autism Diagnostic Observation Schedule-2 (ADOS-2) is adopted to assess the changes in the degree of ASD disorder. The Autism Diagnostic Observation Schedule-2 (ADOS-2) is a standardized observational assessment. The assessment includes abilities in four areas: social interaction, stereotypical behavior, verbal communication, emotion, and abnormal behavior. The participants in the study will be administered a module 1 for children with little or no phrase speech or Module 2, for children who use phrase speech but are not yet fluent. Standardized ADOS scores in the domains of social affect (SA) and restricted repetitive behaviors (RRB) were calculated as indicators of ASD severity.
Measured: Baseline enrollment; 12 months after follow-up
The developmental level in ASD group and TD group
The participants will be assessed using the Gesell Developmental Schedule (GESELL) .The Gesell assessment is a developmental evaluation tool for young children, typically used from birth to age six, to measure skills across fine motor, gross motor, adaptive, language, and personal-social domains.Scores for the five domains (gross motor, fine motor, adaptive, language, and personal-social) will be calculated and compared between groups.
Measured: Baseline enrollment; 12 months after follow-up
The changes of brain function detection indicators
To assess speech perception, two groups of participants will be completed a task-based paradigm while being monitored with functional near-infrared spectroscopy (fNIRS).All participants will undergo an approximately 10-minute speech perception task, during which concentrations of oxygenated hemoglobin in different brain regions and functional connectivity will be recorded.
Measured: Baseline enrollment；12 months after follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start10 Mar 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SpeechStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Li, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472829
- Sponsor's protocol ID
- SDTPMASD
- Status last verified
- Mar 2026
- First submitted
- 1 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is confidential during the study.
Publications
DeVeney SL, Kyvelidou A, Mather P. A home-based longitudinal study of vocalization behaviors across infants at low and elevated risk of autism. Autism Dev Lang Impair. 2021 Nov 24;6:23969415211057658. doi: 10.1177/23969415211057658. eCollection 2021 Jan-Dec.
PubMed 36440373Chenausky KV, Maffei M, Tager-Flusberg H, Green JR. Review of methods for conducting speech research with minimally verbal individuals with autism spectrum disorder. Augment Altern Commun. 2023 Mar;39(1):33-44. doi: 10.1080/07434618.2022.2120071. Epub 2022 Nov 8.
PubMed 36345836Yankowitz LD, Petrulla V, Plate S, Tunc B, Guthrie W, Meera SS, Tena K, Pandey J, Swanson MR, Pruett JR Jr, Cola M, Russell A, Marrus N, Hazlett HC, Botteron K, Constantino JN, Dager SR, Estes A, Zwaigenbaum L, Piven J, Schultz RT, Parish-Morris J; IBIS Network. Infants later diagnosed with autism have lower canonical babbling ratios in the first year of life. Mol Autism. 2022 Jun 27;13(1):28. doi: 10.1186/s13229-022-00503-8.
PubMed 35761377Helland WA, Lundervold AJ, Heimann M, Posserud MB. Stable associations between behavioral problems and language impairments across childhood - the importance of pragmatic language problems. Res Dev Disabil. 2014 May;35(5):943-51. doi: 10.1016/j.ridd.2014.02.016. Epub 2014 Mar 15.
PubMed 24642228Liu M, Han J, Zhang Y, Wen J, Wang Y, Hu X, Sun M, Qu L, Han X, Xu L, Zhao H, Lu H, Liu Q. Phonological Development in 3-6-Year-Old Mandarin-Speaking Children with Autism, Developmental Delays, and Typical Development. J Autism Dev Disord. 2025 Dec;55(12):4312-4323. doi: 10.1007/s10803-024-06522-z. Epub 2024 Aug 23.
PubMed 39177934
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Speech Development Trajectories and Predictive Models in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT07472829
- Acronym / sponsor ID
- SDTPMASD
- Conditions
- Speech, Autism Spectrum Disorder (ASD)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Children's Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 10 Mar 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Mar 2026 (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.
Recent studies indicate that children with ASD have a significantly higher risk of co-occurring speech sound disorders than typically developing children. Early atypical speech development may be a critical yet overlooked bottleneck hindering their language improvement. Given the unique phonetic features of Mandarin, it is essential to investigate speech development in Mandarin-speaking children with ASD. This study aims to construct developmental trajectories and establish early identification and prognosis prediction models for this population.
Detailed description
- Procedures. This study plans to enroll 60 children with autism spectrum disorder (ASD group) and 60 typically developing children (TD group), aged 18-60 months, matched by age and sex. At baseline, both groups will undergo assessments of development, language, and parent-child interaction, as well as fNIRS; the ASD group will additionally receive clinical diagnostic evaluations. Subsequently, a one-year follow-up will be conducted, with both groups completing language and parent-child interaction assessments at 3, 6, 9, and 12 months, and undergoing repeated developmental and fNIRS evaluations at the final 12-month visit.
- Demographic questionnaire and clinical data. The demographic questionnaire is completed by the child's primary caregiver, detailing child's name, gender, date of birth, height, weight, heart rate. Clinical data will be ascertained from the medical records, including information about DSM-5 diagnosis and comorbid conditions.
- Sample size. This study ultimately determined a sample size of 120 participants (60 in the ASD group and 60 in the TD group). The estimation was based on the minimum sample size required to analyze the "group × time" interaction effect using a mixed-effects model (88 participants, achieving 85% power), and fully considered the following factors: ① Meeting the analytical requirements for both the main effects of group and time; ② The need to increase the sample size to 110 participants if multiple comparison corrections (Bonferroni correction, α=0.0083) are applied to the six speech indicators; ③ Considering practical operational challenges such as the long follow-up period, multiple repeated measurements, and anticipated dropout rates, the sample was ultimately expanded to 120 participants to ensure the robustness of the study.
- Statistical analysis. SPSS 25.0 software (SPSS Inc) was used for statistical analysis for the scale data, The speech development trajectories of the two groups can be analyzed using longitudinal methods such as mixed-effects models. Repeated measures ANOVA will compare speech characteristics between the ASD and TD groups at five time points (baseline, 3, 6, 9, and 12 months). Correlation analysis (Pearson or Spearman, depending on normality) will assess the relationship between speech development and core ASD symptoms. ANOVA/MANOVA will examine group differences in speech perception tasks, and exploratory factor analysis will identify underlying factors influencing speech perception.All statistical analyses were conducted with a statistical threshold P-value of <0.05. The data collected through fNIRS will be performed via NirSpark analysis software.
- Ethical matters and data protection. The children participated in the study will sign the informed consent (obtained from the guardian). And this study was approved by the local ethics committee. children's name will be abbreviated and the research data will be assigned a code then to provide to the researcher. The authorization from parents on the children's health information remains valid until the study is completed. After that, researchers will delete private information from the study record.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASD group | – | Behavioral: Approaches to ASD social interventionInclusion criteria: Diagnosed by two or more associate chief physicians using the DSM-5 diagnostic criteria. Participants aged between 18 and 60 months. Participants with a vocabulary size ranging from 0 to 50 words, as assessed using the Chinese Communicative Development Inventory. Participants whose native language is Chinese. Exclusion criteria: Participants not meeting the age requirement. Presence of orofacial motor and swallowing dysfunction. Hearing impairment. Participants whose native language isn't Chinese. Neurological disorders (such as encephalitis or seizures) and comorbid psychiatric disorders. |
| TD group | – | –Inclusion Criteria: Diagnosed as typically developing children by two or more associate chief physicians. Gender- and age-matched to the ASD group. Participants whose native language is Chinese. Exclusion Criteria: Participants not meeting the age requirement. Presence of orofacial motor and swallowing dysfunction. Hearing impairment. Participants whose native language isn't Chinese. Neurological disorders (such as encephalitis or seizures) and comorbid psychiatric disorders. |
Who may qualify
- Ages
- 18 to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- TD group
Key inclusion criteria (3 listed)
- Diagnosed as typically developing children by two or more associate chief physicians.
- Gender- and age-matched to the ASD group.
- Participants whose native language is Chinese.
Key exclusion criteria (5 listed)
- Participants not meeting the age requirement.
- Presence of orofacial motor and swallowing dysfunction.
- Hearing impairment.
- Participants whose native language isn't Chinese.
- Neurological disorders (such as encephalitis or seizures) and comorbid psychiatric disorders.
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 |
|---|---|---|
| Approaches to ASD social interventionThe intervention methods for children in the ASD group will be documented in detail (through telephone or online follow-ups, based on parental reports, with records including the location, time, frequency, and main content of the interventions); children in the TD group did not receive any intervention. | Behavioural | ASD group |
Primary outcome
The language ability of ASD group and TD group by Dream-it
Time frame: Baseline enrollment；3 months ,6 months ,9 months and 12 months after follow-up
The participants will be assessed using the Dream-it, which consists of two separate scales developed for children aged 0-18 months and 18-36 months, respectively. The assessment is conducted via parent report and completed on an iPad. The evaluation covers four domains: language comprehension, language expression, cognitive play, and social communication.The researchers will calculate the participants' scale scores across four dimensions and compare them at different time points.
The language ability of ASD group and TD group by free-play session with one parent
Time frame: Baseline enrollment; 3 months, 6 months, 9 months and 12 months after follow-up
The participants will be engage in a 15-minute semi-structured free-play session with one parent, which will be video-recorded for later coding of behavioral and vocalization measures. The investigators will collect the participant's naturalistic language. Indicators such as the diversity of syllables, the number of vowels, and the number of consonants will be calculated and compared at various time points.
3 secondary outcomes
The changes in degree of ASD disorder by Autism Diagnostic Observation Schedule-2
Time frame: Baseline enrollment; 12 months after follow-up
The developmental level in ASD group and TD group
Time frame: Baseline enrollment; 12 months after follow-up
The changes of brain function detection indicators
Time frame: Baseline enrollment；12 months after follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Results publication: PubMed 36440373DeVeney SL, Kyvelidou A, Mather P. A home-based longitudinal study of vocalization behaviors across infants at low and elevated risk of autism. Autism Dev Lang Impair. 2021 Nov 24;6:23969415211057658. doi: 10.1177/23969415211057658. eCollection 2021 Jan-Dec.
- Results publication: PubMed 36345836Chenausky KV, Maffei M, Tager-Flusberg H, Green JR. Review of methods for conducting speech research with minimally verbal individuals with autism spectrum disorder. Augment Altern Commun. 2023 Mar;39(1):33-44. doi: 10.1080/07434618.2022.2120071. Epub 2022 Nov 8.
- Results publication: PubMed 35761377Yankowitz LD, Petrulla V, Plate S, Tunc B, Guthrie W, Meera SS, Tena K, Pandey J, Swanson MR, Pruett JR Jr, Cola M, Russell A, Marrus N, Hazlett HC, Botteron K, Constantino JN, Dager SR, Estes A, Zwaigenbaum L, Piven J, Schultz RT, Parish-Morris J; IBIS Network. Infants later diagnosed with autism have lower canonical babbling ratios in the first year of life. Mol Autism. 2022 Jun 27;13(1):28. doi: 10.1186/s13229-022-00503-8.
- Results publication: PubMed 24642228Helland WA, Lundervold AJ, Heimann M, Posserud MB. Stable associations between behavioral problems and language impairments across childhood - the importance of pragmatic language problems. Res Dev Disabil. 2014 May;35(5):943-51. doi: 10.1016/j.ridd.2014.02.016. Epub 2014 Mar 15.
- Results publication: PubMed 39177934Liu M, Han J, Zhang Y, Wen J, Wang Y, Hu X, Sun M, Qu L, Han X, Xu L, Zhao H, Lu H, Liu Q. Phonological Development in 3-6-Year-Old Mandarin-Speaking Children with Autism, Developmental Delays, and Typical Development. J Autism Dev Disord. 2025 Dec;55(12):4312-4323. doi: 10.1007/s10803-024-06522-z. Epub 2024 Aug 23.
- Individual participant dataSharing planned: No. Data is confidential during the study.
Related trials for Speech
Recruiting
Using Non-invasive Brain Stimulation to Explore Potential Treatments to Reduce Speech Errors in Adults Who Stutter
Stuttering, Fluency Disorder
Recruiting
Vowel Space Expansion Sensorimotor Adaptation
Speech
RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
Aphasia, Stroke
RecruitingObservational study
Speech and Language Interventions for Italian People With PPA
Primary Progressive Aphasia(PPA)
Active, not recruiting
A Randomized Control Trial of Motor-based Intervention for CAS
Childhood Apraxia of Speech
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Speech and Autism Spectrum Disorder (ASD), run by Children's Hospital of Chongqing Medical University.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Chen, Doctor (13677620103 ext. +86, chenli@cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The language ability of ASD group and TD group by Dream-it (time frame: Baseline enrollment；3 months ,6 months ,9 months and 12 months after follow-up). The study lists 2 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 NCT07472829, which also lists 5 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 17 Mar 2026.