An observational study in Speech and Autism Spectrum Disorder (ASD), sponsored by Children's Hospital of Chongqing Medical University. Not yet recruiting. Open to participants aged 18 Months to 60 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by Children's Hospital of Chongqing Medical University · Observational
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.
TD group
Exclusion Criteria:
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
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.
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.
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.
Time frame: 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.
Time frame: Baseline enrollment; 3 months, 6 months, 9 months and 12 months after follow-up
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline enrollment；12 months after follow-up
No study locations are listed for this record.
Plan to share: No — Data is confidential during the study.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Children's Hospital of Chongqing Medical University