NCT05442229

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,744

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

July 1, 2022

Status Verified

March 1, 2022

Enrollment Period

8 months

First QC Date

June 28, 2022

Last Update Submit

June 28, 2022

Conditions

Keywords

language developmentdevelopment assessmentspeech and language assessment scale

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

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

Interventions

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 childNormally developing child

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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

You may qualify if:

  • 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.
  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Intellectual DisabilityAutism Spectrum DisorderAttention Deficit Disorder with HyperactivitySpeech

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersChild Development Disorders, PervasiveAttention Deficit and Disruptive Behavior DisordersVerbal BehaviorCommunicationBehavior

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2022

First Posted

July 1, 2022

Study Start

July 1, 2022

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

July 1, 2022

Record last verified: 2022-03