NCT04440852

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
Last Updated

June 22, 2020

Status Verified

June 1, 2020

Enrollment Period

2 years

First QC Date

June 11, 2020

Last Update Submit

June 17, 2020

Conditions

Keywords

TEACCH

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

TEACCH intervention

EXPERIMENTAL

TEACCH intervention for ASD

Behavioral: TEACCH

conventional rehabilitation group

NO INTERVENTION

Other conventional interventions

Interventions

TEACCHBEHAVIORAL

The Treatment and Education of Autistic and Communication Handicapped Children

TEACCH intervention

Eligibility Criteria

Age36 Months - 90 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan Mental Health Centre

Wuhan, Hubei, 430014, China

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Hongling Zeng, Master

    Wuhan Mental Health Centre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2020

First Posted

June 22, 2020

Study Start

January 1, 2018

Primary Completion

December 31, 2019

Study Completion

March 30, 2020

Last Updated

June 22, 2020

Record last verified: 2020-06

Locations