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NCT Number: NCT04440852

Randomized, Controlled Trial of an Intervention for Preschool Children With Autism: TEACCH

This study is design to evaluate the efficacy of the Treatment and Education of Autistic and Communication Handicapped Children (TEACCH) on the rehabilitation for preschool children with autism spectrum disorders (ASD) in China.A case-randomized controlled study was conducted.Sixty children diagnosed with ASD between 36 and 90 months of age were randomly assigned to the a TEACCH intervention group or a control group.The control group was subjected to regular rehabilitation training, the TEACCH group carried out TEACCH training besides regular rehabilitation training for 6 months. Chinese Version of Psycho-educational Profile-3rd edition (CPEP-3) was used to evaluate the effectiveness of TEACCH rehabilitation training.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

36 month–90 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wuhan Mental Health Centre

Wuhan, Hubei, 430014, China

About this study

Statistical analysis plan:The results were analyze using descriptive, t-test and ANOVA.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosed by two children's psychiatrists above the level of the attending physician, in accordance with the diagnostic criteria of DSM-V (Diagnostic and Statistical Manual of Mental Disorder, fifth revised) children's autism spectrum disorder issued by the United States in 2013. Diagnostic screening scales include Autism Behavior Checklist (ABC), Childhood Autism Rating Scale (CARS), and Modified Checklist for Autism in Toddlers (M-CHAT) (for under 4 years old), Social Communication Questionnaire (SCQ) (for over 4 years old), all children' scores above the scale suggest ASD performance;
  • able to cooperate with clinical evaluation and related examinations, and the guardian signs the informed consent to agree to participate in the study.

Exclusion criteria

  • combined with other mental illnesses such as ADHD, with major physical and nervous system diseases;
  • serious self-harm.

Treatment and study plan

TEACCH

Behavioral

The Treatment and Education of Autistic and Communication Handicapped Children

Primary outcomes

  1. Chinese Version of Psycho-educational Profile-3rd edition (CPEP-3)

    Time frame: pretest

    a validated assessment tool that comprehensively measures the development of Chinese children with ASD

  2. Chinese Version of Psycho-educational Profile-3rd edition (CPEP-3)

    Time frame: posttest: 6 months to pretest

    a validated assessment tool that comprehensively measures the development of Chinese children with ASD

  3. Chinese Version of Psycho-educational Profile-3rd edition (CPEP-3)

    Time frame: 6 months follow-up : 1 year to pretest

    a validated assessment tool that comprehensively measures the development of Chinese children with ASD

Sponsors and collaborators

Lead sponsor

Wuhan Mental Health Centre

Other

Collaborators

  • Wuhan University

Registry information

Official study title

Effect of TEACCH Program on the Rehabilitation Training for Preschool Children With Autistic Spectrum Disorder: A Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jun 22, 2020
Registry last updated
Jun 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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