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

Study Overview
=================
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.

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

Conditions
-----------------
Autism Spectrum Disorder

Intervention / Treatment
-----------------
* Behavioral: TEACCH


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 36 Months
Maximum Age: 90 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TEACCH intervention<br>TEACCH intervention for ASD | Behavioral: TEACCH<br>* The Treatment and Education of Autistic and Communication Handicapped Children<br>|
| No Intervention: conventional rehabilitation group<br>Other conventional interventions | |

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TEACCH