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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043606
Receipt No. R000048579
Scientific Title A randomised controlled trial of ACAT, a psychoeducational programme for adults with high-functioning autism spectrum disorder.
Date of disclosure of the study information 2021/03/17
Last modified on 2021/08/18

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Basic information
Public title A randomised controlled trial of ACAT, a psychoeducational programme for adults with high-functioning autism spectrum disorder.
Acronym A randomised controlled trial of ACAT
Scientific Title A randomised controlled trial of ACAT, a psychoeducational programme for adults with high-functioning autism spectrum disorder.
Scientific Title:Acronym A randomised controlled trial of ACAT
Region
Japan

Condition
Condition High-functioning Autism Spectrum Disorders
Classification by specialty
Pediatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of psychoeducational program based cognitive behavioral therapy for autism spectrum disorders (18-30years) . Half were randomly assigned to program, and compared with the others receiving no additional intervention. ASD-related self-awareness, the primary outcome, was evaluated using the bespoke Adaptive Behavior Composite score for Japanese version of Vineland 2.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Adaptive Behavior Composite score for Japanese version of Vineland 2 at 6 weeks after intervention
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Cognitive behavior therapy
Interventions/Control_2 Treatment as Usual18
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
30 years-old >=
Gender Male and Female
Key inclusion criteria 1)Individual with who have diagnosis of autism spectrum disorder.
2)Verbal intelligence quotient of patients is over 90.
3)Individual with who are above "some need" in Strengths & Difficulties Questionnaires.
4)Age of patients is over 10 to 17 year
5)Caregivers can attend their CBT session with patients.
6)Individual with who have "treatment as usual" does not add an new treatment.
7)Patients can understand CBT.
8)The patients who are diagnosed anxiety disorder and depression can attend this study if they are primaly diagnosed of ASD.
9)Caregivers should not have any psychiatric deseases.
10)Caregivers can attend each CBT session with patients.
Key exclusion criteria 1)Individual with who have an organic disorder
2)Individual with who have suicidal atempt.
3)Individual with who have antisocial conditions.
4)Individual with who have serious psycical disorder.
5)Individual with who have low IQ(under 90 of VIQ)
6)Individual with whoes caregivers cannot attend the sessions.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Eiji
Middle name
Last name Shimizu
Organization Chiba University
Division name Research Center for Child Mental Development
Zip code 260-8670
Address 1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL 043-226-2975
Email eiji@faculty.chiba-u.jp

Public contact
Name of contact person
1st name Oshima
Middle name
Last name Fumiyo
Organization Chiba University
Division name Research Center for Child Mental Development
Zip code 260-8670
Address 1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL 043-226-2975
Homepage URL
Email f_oshima@chiba-u.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research(KAKENHI)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Chiba University Clinical Research Ethical Review Committee
Address 1-8-1 Inohana Chioku Chiba
Tel 043-226-2630
Email ayamazaki@office.chiba-u.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2021 Year 03 Month 17 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2021 Year 01 Month 12 Day
Date of IRB
2021 Year 01 Month 12 Day
Anticipated trial start date
2021 Year 03 Month 18 Day
Last follow-up date
2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 03 Month 13 Day
Last modified on
2021 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048579

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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