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

March 14, 2026 updated by: Chen Li, Children's Hospital of Chongqing Medical University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

TD group

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
Baseline enrollment; 3 months, 6 months, 9 months and 12 months after follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The changes in degree of ASD disorder by Autism Diagnostic Observation Schedule-2
Time Frame: Baseline enrollment; 12 months after follow-up
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.
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 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.
Baseline enrollment; 12 months after follow-up
The changes of brain function detection indicators
Time Frame: Baseline enrollment；12 months after follow-up
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.
Baseline enrollment；12 months after follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital of Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SDTPMASD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data is confidential during the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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