Research on Speech Development Trajectories and Predictive Models in Children With Autism Spectrum Disorder

NCT07472829 | Not Yet Recruiting

• 1 other identifier: SDTPMASD
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Speech; Autism Spectrum Disorder (ASD)

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  Baseline enrollment; 12 months after follow-up

• The developmental level in ASD group and TD group

  Baseline enrollment; 12 months after follow-up

• The changes of brain function detection indicators

  Baseline enrollment；12 months after follow-up

Study Arms (2)

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.

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.

Interventions

Approaches to ASD social intervention BEHAVIORAL

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.

ASD group

Eligibility Criteria

• Age: 18 Months - 60 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

TD group

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Chongqing Medical University: lead

Related Publications (5)

• 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.

  PMID: 36440373 RESULT

• Chenausky 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.

  PMID: 36345836 RESULT

• Yankowitz 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.

  PMID: 35761377 RESULT

• Helland 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.

  PMID: 24642228 RESULT

• Liu 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.

  PMID: 39177934 RESULT

MeSH Terms

Conditions

Speech; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Verbal Behavior; Communication; Behavior; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Li Chen, Doctor

CONTACT

13677620103; chenli@cqmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director

Study Record Dates

• First Submitted: March 1, 2026
• First Posted: March 16, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share