A Cross-sectional Study to Evaluate Speech and Language Development in Chinese Children Aged 2-6 Years

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Autism Spectrum Disorder; Attention Deficit Hyperactivity Disorder; Mental Retardation
• Intervention / Treatment: Other: establish a new Chinese children's speech and language norm

Detailed Description

1. 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.
2. 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 Type: Observational
• Enrollment (Anticipated): 5744

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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

Description

Inclusion Criteria:

For normally developing children

1. All children must meet all of the following criteria simultaneously:
2. Informed consent of legal guardian or group representative;
3. Age from 2 to 6 years old, male and female;
4. Native speaker of Mandarin;

5. 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.

   For abnormally developed children

6. Informed consent of legal guardian or group representative;
7. Age from 2 to 6 years old, male and female;
8. Native speaker of Mandarin;
9. 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)

Exclusion Criteria:

For normally developing children

1. Poor coordination;

2. 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

3. Study the poor fit degree;
4. Have visual and hearing impairment;
5. Other unsuitable children considered by researchers, such as children with other organic dysfunction, such as cerebral palsy, congenital genetic diseases, epilepsy, etc.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Other: establish a new Chinese children's speech and language norm; 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.
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.	Other: establish a new Chinese children's speech and language norm; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2021.11.1-2023.5.1

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (Actual): July 1, 2022

Study Record Updates

• Last Update Posted (Actual): July 1, 2022
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: language development; development assessment; speech and language assessment scale
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Disease; Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder; Intellectual Disability
• Other Study ID Numbers: WHTJYYLB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No