Mental RetardationNCT05442229
A Cross-sectional Study to Evaluate Speech and Language Development in Chinese Children Aged 2-6 Years
An observational study of Mental Retardation and Autism Spectrum Disorder, run by Tongji Hospital.
Trial summary
The purpose of this study is to establish a new Chinese children's speech and language norm by obtaining the latest data of speech and language development of children aged 2 ~ 6 from different regions in China. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Mental Retardation, Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder
- What is being tested?
- establish a new Chinese children's speech and language norm
- How many people
- 5,744 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 28 Feb 2023
- Phase
- Observational
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: 2 to 6 years of normal and abnormal development of children in 11 hospitals in China (covering central, east, South, west, North and east China) North area) and the corresponding area of the kindergarten
Who may be able to join
- For normally developing children
- All children must meet all of the following criteria simultaneously:
- Informed consent of legal guardian or group representative;
- Age from 2 to 6 years old, male and female;
- Native speaker of Mandarin;
- Children in kindergartens and hospitals are professionally assessed as normal development, which is defined as children without intellectual development disorder, developmental speech or language disorder, autism spectrum disorder, and attention deficit hyperactivity disorder.
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- For abnormally developed children
- Informed consent of legal guardian or group representative;
- Age from 2 to 6 years old, male and female;
- Native speaker of Mandarin;
- Children with intellectual development disorder, autism spectrum disorder and attention deficit hyperactivity disorder are assessed professionally in the hospital; Diagnostic criteria were referred to Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
Who cannot join
- For normally developing children
- Poor coordination;
- Other unsuitable children considered by researchers, such as children whose developmental level is basically normal but whose environmental and socio-economic factors (premature birth, low birth weight, malnutrition, abuse, etc.) have been verified to affect language development.
- For abnormally developed children
- Study the poor fit degree;
- Have visual and hearing impairment;
- Other unsuitable children considered by researchers, such as children with other organic dysfunction, such as cerebral palsy, congenital genetic diseases, epilepsy, etc.
About this study
Official title: A Study to Establish the Norm of Chinese Speech and Language Development in Children Aged 2 ~ 6
The purpose of this study is to establish a new Chinese children's speech and language norm by obtaining the latest data of speech and language development of children aged 2 ~ 6 from different regions in China. At the same time, the overall development level and group differences of speech and language in Chinese children aged 2 to 6 years, and the influencing factors of speech and language development in Chinese children aged 2 to 6 years were also discussed.
Read the detailed description
- To establish the norm of speech and language development in Chinese children aged 2 to 6 1063 normally developing children and 96 abnormally developing children will be retrospectively enrolled from the medical records of stratified, randomly selected centers. A total of 4137 children with normal development and 448 children with abnormal development aged from 2 to 6 years old will be selected from 11 hospitals in China by multi-center, stratified, unequal proportion random sampling and face-to-face survey. Children's speech and language development was assessed by the Speech and Language Development Scale for children aged 2 to 6, compiled by the Linguistics and Language Research Centre of the Education University of Hong Kong.
- To investigate and analyze the present situation of speech and language development of children aged 2-6 in China The present situation of children's speech and language development was analyzed, and the differences of gender, age, birth and other influencing factors were statistically analyzed.
- Being tested
- establish a new Chinese children's speech and language norm
- Keywords
- language development, development assessment, speech and language assessment scale
- Medical subject headings
- Intellectual Disability, Autism Spectrum Disorder, Attention Deficit Disorder with Hyperactivity, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
establish a new Chinese children's speech and language normOther
1063 normally developing children and 96 abnormally developing children will be retrospectively enrolled from the medical records of stratified, randomly selected centers. A total of 4137 children with normal development and 448 children with abnormal development aged from 2 to 6 years old will be selected from 11 hospitals in China by multi-center, stratified, unequal proportion random sampling and face-to-face survey. Children's speech and language development was assessed by the Speech and Language Development Scale for children aged 2 to 6, compiled by the Linguistics and Language Research Centre of the Education University of Hong Kong.
| Study group | Role | What they receive |
|---|---|---|
| Normally developing child | Normal development is defined as children without intellectual development disorders, developmental speech or language disorders, ASD (autism spectrum disorder), and ADHD (attention deficit hyperactivity disorder). Receives: Other: establish a new Chinese children's speech and language norm | |
| Abnormally developed child | Abnormal development is defined as that hospital visits of children were professionally assessed for MR (mental retardation), ASD (autism spectrum disorder), and ADHD (attention deficit hyperactivity disorder). Diagnostic criteria were all referred to Diagnostic and Statistical Manual of Mental Disorders，DSM-5. Receives: Other: establish a new Chinese children's speech and language norm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chinese children's speech and language norm
The speech and Language Development Scale for children aged 2 to 6 was developed by the Linguistics and Language Research Center of the Education University of Hong Kong. It was divided into three parts: phonological assessment (word pronunciation), vocabulary assessment (comprehension and expression) and grammar assessment (comprehension). Color hand-painted pictures were used for the evaluation of the three types of items, and words were named by pictures, and words were selected by listening and listening, so as to ensure the practicality and conciseness of the scale, as well as the simplicity of operation and implementation. Finally, the total score of each subject was calculated and relevant developmental status conclusions were drawn.
Measured: 2021.11.1-2023.5.1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start1 Jul 2022 (estimated)
- Primary completion28 Feb 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental RetardationStudies 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
- 5,744 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442229
- Sponsor's protocol ID
- WHTJYYLB
- Status last verified
- Mar 2022
- First submitted
- 28 Jun 2022
- Last updated
- 1 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Establish the Norm of Chinese Speech and Language Development in Children Aged 2 ~ 6
- ClinicalTrials.gov ID
- NCT05442229
- Acronym / sponsor ID
- WHTJYYLB
- Keywords
- language development, development assessment, speech and language assessment scale
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,744 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 1 Jul 2022 (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 purpose of this study is to establish a new Chinese children's speech and language norm by obtaining the latest data of speech and language development of children aged 2 ~ 6 from different regions in China. At the same time, the overall development level and group differences of speech and language in Chinese children aged 2 to 6 years, and the influencing factors of speech and language development in Chinese children aged 2 to 6 years were also discussed.
Detailed description
- To establish the norm of speech and language development in Chinese children aged 2 to 6 1063 normally developing children and 96 abnormally developing children will be retrospectively enrolled from the medical records of stratified, randomly selected centers. A total of 4137 children with normal development and 448 children with abnormal development aged from 2 to 6 years old will be selected from 11 hospitals in China by multi-center, stratified, unequal proportion random sampling and face-to-face survey. Children's speech and language development was assessed by the Speech and Language Development Scale for children aged 2 to 6, compiled by the Linguistics and Language Research Centre of the Education University of Hong Kong.
- To investigate and analyze the present situation of speech and language development of children aged 2-6 in China The present situation of children's speech and language development was analyzed, and the differences of gender, age, birth and other influencing factors were statistically analyzed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normally developing child | – | Other: establish a new Chinese children's speech and language normNormal development is defined as children without intellectual development disorders, developmental speech or language disorders, ASD (autism spectrum disorder), and ADHD (attention deficit hyperactivity disorder). |
| Abnormally developed child | – | Other: establish a new Chinese children's speech and language normAbnormal development is defined as that hospital visits of children were professionally assessed for MR (mental retardation), ASD (autism spectrum disorder), and ADHD (attention deficit hyperactivity disorder). Diagnostic criteria were all referred to Diagnostic and Statistical Manual of Mental Disorders，DSM-5. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 2 to 6 years of normal and abnormal development of children in 11 hospitals in China (covering central, east, South, west, North and east China) North area) and the corresponding area of the kindergarten
Key inclusion criteria (11 listed)
- For normally developing children
- All children must meet all of the following criteria simultaneously:
- Informed consent of legal guardian or group representative;
- Age from 2 to 6 years old, male and female;
- Native speaker of Mandarin;
Key exclusion criteria (7 listed)
- For normally developing children
- Poor coordination;
- Other unsuitable children considered by researchers, such as children whose developmental level is basically normal but whose environmental and socio-economic factors (premature birth, low birth weight, malnutrition, abuse, etc.) have been verified to affect language development.
- For abnormally developed children
- Study the poor fit degree;
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 |
|---|---|---|
| establish a new Chinese children's speech and language norm1063 normally developing children and 96 abnormally developing children will be retrospectively enrolled from the medical records of stratified, randomly selected centers. A total of 4137 children with normal development and 448 children with abnormal development aged from 2 to 6 years old will be selected from 11 hospitals in China by multi-center, stratified, unequal proportion random sampling and face-to-face survey. Children's speech and language development was assessed by the Speech and Language Development Scale for children aged 2 to 6, compiled by the Linguistics and Language Research Centre of the Education University of Hong Kong. | Other | Abnormally developed child, Normally developing child |
Primary outcome
Chinese children's speech and language norm
Time frame: 2021.11.1-2023.5.1
The speech and Language Development Scale for children aged 2 to 6 was developed by the Linguistics and Language Research Center of the Education University of Hong Kong. It was divided into three parts: phonological assessment (word pronunciation), vocabulary assessment (comprehension and expression) and grammar assessment (comprehension). Color hand-painted pictures were used for the evaluation of the three types of items, and words were named by pictures, and words were selected by listening and listening, so as to ensure the practicality and conciseness of the scale, as well as the simplicity of operation and implementation. Finally, the total score of each subject was calculated and relevant developmental status conclusions were drawn.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Retardation and Autism Spectrum Disorder, run by Tongji Hospital.
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 11 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 1 Jul 2022. 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?
Results are not available in the source record.
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?
Chinese children's speech and language norm (time frame: 2021.11.1-2023.5.1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2022; AzTrials last refreshed its copy on 27 Oct 2026.