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

NCT ID: NCT04440852

Last Updated: 2020-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-03-30

Brief Summary

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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

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

Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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TEACCH intervention

TEACCH intervention for ASD

Group Type EXPERIMENTAL

TEACCH

Intervention Type BEHAVIORAL

The Treatment and Education of Autistic and Communication Handicapped Children

conventional rehabilitation group

Other conventional interventions

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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TEACCH

The Treatment and Education of Autistic and Communication Handicapped Children

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

36 Months

Maximum Eligible Age

90 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wuhan University

OTHER

Sponsor Role collaborator

Wuhan Mental Health Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hongling Zeng, Master

Role: STUDY_DIRECTOR

Wuhan Mental Health Centre

Locations

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Wuhan Mental Health Centre

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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KY2016(53)

Identifier Type: -

Identifier Source: org_study_id

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