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

June 17, 2020 updated by: Wuhan Mental Health Centre

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430014
        • Wuhan Mental Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TEACCH intervention
TEACCH intervention for ASD
Behavioral: TEACCH
The Treatment and Education of Autistic and Communication Handicapped Children
No Intervention: conventional rehabilitation group
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)
Time Frame: pretest
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)
Time Frame: posttest: 6 months to pretest
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)
Time Frame: 6 months follow-up : 1 year to pretest
a validated assessment tool that comprehensively measures the development of Chinese children with ASD
6 months follow-up : 1 year to pretest

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan Mental Health Centre

Collaborators

Wuhan University

Investigators

  • Study Director: Hongling Zeng, Master, Wuhan Mental Health Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

March 30, 2020

Study Registration Dates

First Submitted

June 11, 2020

First Submitted That Met QC Criteria

June 17, 2020

First Posted (Actual)

June 22, 2020

Study Record Updates

Last Update Posted (Actual)

June 22, 2020

Last Update Submitted That Met QC Criteria

June 17, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2016(53)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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