UMIN-CTR Clinical Trial

Basic information
Public title	An open trial of the work support effect of group cognitive behacioral therapy for autistic spectrum disorders
Acronym	An open trial of work support of CBT for ASD
Scientific Title	An open trial of the work support effect of group cognitive behacioral therapy for autistic spectrum disorders
Scientific Title:Acronym	An open trial of work support of CBT for ASD
Region	Japan

Condition
Condition	Autistic spectrum disorders
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine work supporting effect of group cognitive behavioral therapy for patients with autistic spectrum disorders
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	The change of total score of SFS-J between at the beginning and at the time of follow-up session
Key secondary outcomes	The change of each subscale of SFS-J, total score and each subscale of WHODAS2.0, total score and each subscale of LSAS-J, total score of BDI-II, total score of RSES-J between at the beginning and at the time of follow-up session The change of total score and each subscale of SFS-J, total score and each subscale of WHODAS2.0, total score and each subscale of LSAS-J, total score of BDI-II, total score of RSES-J between at the beginning and at the end of therapy

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	A series of 12 sessions of group cognitive behavioral therapy
Interventions/Control_2
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	16 years-old <=
Age-upper limit	40 years-old >
Gender	Male and Female
Key inclusion criteria	1. Autistic spectrum disorders defined by DSM-5 2. Outpatients of Chiba University Hospital 3. Age between 16 and 40
Key exclusion criteria	1. Incompetent 2. F0, F1 (excluding caffeine and nicotine), F2, F7 in ICD-10 3. Uncontrollable mental disorders other than above 4. Uncontrollable physical diseases 5. Having participated in other intervening clinical trials within three months 6. Suicidal attempts within one year 7. Prohibited by the doctor in charge
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Akihiro Middle name Last name Shiina
Organization	Center for Forensic Mental Health, Chiba University
Division name	Devision of Medical Treatment and Rehabilitation
Zip code	2608670
Address	Inohana 1-8-1, Chuoh-ku, Chiba-shi, Chiba-ken, Japan
TEL	043-222-7171
Email	shiina-akihiro@faculty.chiba-u.jp

Public contact
Name of contact person	1st name Akihiro Middle name Last name Shiina
Organization	Center for Forensic Mental Health, Chiba University
Division name	Devision of Medical Treatment and Rehabilitation
Zip code	2608670
Address	Inohana 1-8-1, Chuoh-ku, Chiba-shi, Chiba-ken, Japan
TEL	043-222-7171
Homepage URL
Email	shiina-akihiro@faculty.chiba-u.jp

Sponsor
Institute	Devision of Medical Treatment and Rehabilitation, Center for Forensic Mental Health, Chiba University
Institute
Department

Funding Source
Organization	The Japan Science Society
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Clinical Research Center of Chiba University Hospital
Address	Inohana 1-8-1, Chuoh-ku, Chiba-shi, Chiba-ken
Tel	043-222-7171
Email	chibacrc@mac.com

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	2016 Year 06 Month 23 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	26
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	2016 Year 06 Month 20 Day
Date of IRB	2016 Year 06 Month 26 Day
Anticipated trial start date	2016 Year 06 Month 26 Day
Last follow-up date	2019 Year 09 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 06 Month 23 Day
Last modified on	2019 Year 09 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026334