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

Not Applicable

Completed

• Conditions: Autism Spectrum Disorder
• Interventions: Behavioral: TEACCH

• Registration Number: NCT04440852
• Lead Sponsor: Wuhan Mental Health Centre

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-03-30
• Status Verified: 2020-06
• Study First Submitted: 2020-06-11
• Study First Submitted QC: 2020-06-17
• Last Update Submitted: 2020-06-17
• Study First Posted: 2020-06-22
• Last Update Posted: 2020-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TEACCH intervention	TEACCH	TEACCH intervention for ASD

Primary Outcome Measures

Name	Time	Method
Chinese Version of Psycho-educational Profile-3rd edition (CPEP-3)	6 months follow-up : 1 year to pretest	a validated assessment tool that comprehensively measures the development of Chinese children with ASD

Trial Locations

Locations (1)

Wuhan Mental Health Centre; 🇨🇳 Wuhan, Hubei, China