UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029851 |
|---|---|
| Receipt number | R000034036 |
| Scientific Title | A randomised controlled trial of ACAT, a psychoeducational programme for young people with high-functioning autism spectrum disorder and their families. |
| Date of disclosure of the study information | 2018/01/06 |
| Last modified on | 2021/03/25 11:21:09 |
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Basic information
Public title
A randomised controlled trial of ACAT, a psychoeducational programme for young people with high-functioning autism spectrum disorder and their families.
Acronym
A randomised controlled trial of ACAT
Scientific Title
A randomised controlled trial of ACAT, a psychoeducational programme for young people with high-functioning autism spectrum disorder and their families.
Scientific Title:Acronym
A randomised controlled trial of ACAT
Region
| Japan |
Condition
Condition
High-functioning Autism Spectrum Disorders
Classification by specialty
| Pediatrics | Psychiatry | Child |
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 (10-17 years) and their parents. 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 Autism Knowledge Quiz.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The section 1 in the Autism Knowledge Quiz for young people
Key secondary outcomes
For patient: Barriers to Access to Care Evaluation 3rd Edition,Strengths and Difficulties Questionnaire ,Vineland-2,DSRS-C, EEG, self understanding questionarie.
For parents: Barriers to Access to Care Evaluation, Autism Knowledge Quiz for Parent,Parenting Resilience Elements Questionnaire,GHQ12, EEG.
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 Usual
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
| 10 | years-old | <= |
Age-upper limit
| 17 | 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
48
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
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
f_oshima@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Japanese Clinical Psychology Institute
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka University
Hamamatsu Medical University
Fukusima University
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
ayamazaki@office.chiba-u.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
G29027
Org. issuing International ID_1
Chiba University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 06 | Day |
Related information
URL releasing protocol
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04750-z
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
49
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
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 07 | Day |
Last modified on
| 2021 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034036
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