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

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TEACCH
Sponsored by
Wuhan Mental Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring TEACCH

Eligibility Criteria

36 Months - 90 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wuhan Mental Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TEACCH intervention

conventional rehabilitation group

Arm Description

TEACCH intervention for ASD

Other conventional interventions

Outcomes

Primary Outcome Measures

Chinese Version of Psycho-educational Profile-3rd edition (CPEP-3)
a validated assessment tool that comprehensively measures the development of Chinese children with ASD
Chinese Version of Psycho-educational Profile-3rd edition (CPEP-3)
a validated assessment tool that comprehensively measures the development of Chinese children with ASD
Chinese Version of Psycho-educational Profile-3rd edition (CPEP-3)
a validated assessment tool that comprehensively measures the development of Chinese children with ASD

Secondary Outcome Measures

Full Information

First Posted
June 11, 2020
Last Updated
June 17, 2020
Sponsor
Wuhan Mental Health Centre
Collaborators
Wuhan University
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1. Study Identification

Unique Protocol Identification Number
NCT04440852
Brief Title
Randomized, Controlled Trial of an Intervention for Preschool Children With Autism: TEACCH
Official Title
Effect of TEACCH Program on the Rehabilitation Training for Preschool Children With Autistic Spectrum Disorder: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wuhan Mental Health Centre
Collaborators
Wuhan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
TEACCH

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TEACCH intervention
Arm Type
Experimental
Arm Description
TEACCH intervention for ASD
Arm Title
conventional rehabilitation group
Arm Type
No Intervention
Arm Description
Other conventional interventions
Intervention Type
Behavioral
Intervention Name(s)
TEACCH
Intervention Description
The Treatment and Education of Autistic and Communication Handicapped Children
Primary Outcome Measure Information:
Title
Chinese Version of Psycho-educational Profile-3rd edition (CPEP-3)
Description
a validated assessment tool that comprehensively measures the development of Chinese children with ASD
Time Frame
pretest
Title
Chinese Version of Psycho-educational Profile-3rd edition (CPEP-3)
Description
a validated assessment tool that comprehensively measures the development of Chinese children with ASD
Time Frame
posttest: 6 months to pretest
Title
Chinese Version of Psycho-educational Profile-3rd edition (CPEP-3)
Description
a validated assessment tool that comprehensively measures the development of Chinese children with ASD
Time Frame
6 months follow-up : 1 year to pretest

10. Eligibility

Sex
All
Minimum Age & Unit of Time
36 Months
Maximum Age & Unit of Time
90 Months
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongling Zeng, Master
Organizational Affiliation
Wuhan Mental Health Centre
Official's Role
Study Director
Facility Information:
Facility Name
Wuhan Mental Health Centre
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430014
Country
China

12. IPD Sharing Statement

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

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