Autism Spectrum DisorderNCT04440852
Randomized, Controlled Trial of an Intervention for Preschool Children With Autism: TEACCH
A study testing TEACCH in people with Autism Spectrum Disorder, run by Wuhan Mental Health Centre at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 36 to 90 months
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- TEACCH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 90 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- combined with other mental illnesses such as ADHD, with major physical and nervous system diseases;
- serious self-harm.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
Statistical analysis plan:The results were analyze using descriptive, t-test and ANOVA.
- Conditions
- Autism Spectrum Disorder
- Being tested
- TEACCH
- Keywords
- TEACCH
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEACCHBehavioural
The Treatment and Education of Autistic and Communication Handicapped Children
| Study group | Role | What they receive |
|---|---|---|
| TEACCH intervention | Experimental | TEACCH intervention for ASD Receives: Behavioral: TEACCH |
| conventional rehabilitation group | No intervention | Other conventional interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chinese Version of Psycho-educational Profile-3rd edition (CPEP-3)
a validated assessment tool that comprehensively measures the development of Chinese children with ASD
Measured: 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
Measured: 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
Measured: 6 months follow-up : 1 year to pretest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Jan 2018
- Primary completion31 Dec 2019
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan Mental Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan University
- Responsible party
- Sponsor
- Investigators
- Hongling Zeng, Master, Study director, Wuhan Mental Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440852
- Sponsor's protocol ID
- KY2016(53)
- Status last verified
- Jun 2020
- First submitted
- 11 Jun 2020
- Last updated
- 22 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of TEACCH Program on the Rehabilitation Training for Preschool Children With Autistic Spectrum Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04440852
- Acronym / sponsor ID
- KY2016(53)
- Conditions
- Autism Spectrum Disorder
- Keywords
- TEACCH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wuhan Mental Health CentreUniversity, hospital or other
- Collaborators
- Wuhan University
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEACCH intervention | Experimental | Behavioral: TEACCHTEACCH intervention for ASD |
| conventional rehabilitation group | No intervention | –Other conventional interventions |
Who may qualify
- Ages
- 36 to 90 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- combined with other mental illnesses such as ADHD, with major physical and nervous system diseases;
- serious self-harm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEACCHThe Treatment and Education of Autistic and Communication Handicapped Children | Behavioural | TEACCH intervention |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongling Zeng, Master study director
Wuhan Mental Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEACCH in people with Autism Spectrum Disorder, run by Wuhan Mental Health Centre at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chinese Version of Psycho-educational Profile-3rd edition (CPEP-3) (time frame: pretest). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020.