UMIN-CTR Clinical Trial

Basic information
Public title	A study of group cognitive behavioral therapy for parents of individuals with hikikomori
Acronym	Cognitive behavioral therapy for parents of hikikomori
Scientific Title	Clinical trial of group cognitive behavioral therapy (CBT) for parents of individuals with hikikomori (randomized controlled trial of the efficacy of the CBT group compared to the waiting group)
Scientific Title:Acronym	RCT of group CBT for parents of hikikomori
Region	Japan

Condition
Condition	none
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify whether group cognitive behavioral therapy is more effective for parents of individuals with hikikomori than the waiting group.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Total time of one week from (1) to (3) of Individuals with hikikomori : (1) Talking face-to-face with participants at home, (2) Talking face-to-face with other family members and others at home, (3) individual with hikikomori goes out,
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Maneuver
Interventions/Control_1	Program: Once a week for 60 minutes. And 8 times in total.
Interventions/Control_2	We distribute leaflet about withdrawal.
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	Not applicable
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	Parents who meet all of the following conditions (in principle, a mother, but may be a father). 1) to be under 70 years old. 2) to be able to participate in all programs. 3) Age of the child is 16 years or older.
Key exclusion criteria	Those who meet any of the following conditions are not eligible. 1) Those who are expected to be suspended in case the participant has a severe mental or physical illness such as brain disorder (including dementia), psychotic disorder, bipolar disorder, drug dependence, etc. 2) In case the individual with hikikomori, who is the child of the participant, cannot obtain the consent of the attending physician who is a psychiatric department. 3) In case a child with hikikomori is committing violence at home. 4) When there are two or more individuals with hikikomori at home. 5) The individual who is judged inappropriate by the investigator or the therapist in charge of the study to perform this test safely.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name EIJI Middle name Last name SHIMIZU
Organization	Chiba University Hospital
Division name	Cognitive Behavioral Therapy Center
Zip code	260-8677
Address	1-8-1 inohana chuo-ku chiba-city CHIBA
TEL	043-226-2027
Email	eiji@faculty.chiba-u.jp

Public contact
Name of contact person	1st name TOMOKO Middle name Last name OKUDA
Organization	Chiba University Graduate School of Medicine
Division name	Cognitive behavioral physiology
Zip code	260-8677
Address	1-8-1 inohana chuo-ku chiba-city CHIBA
TEL	043-226-2027
Homepage URL
Email	okuda_tomoko@chiba-u.jp

Sponsor
Institute	Chiba University
Institute
Department

Funding Source
Organization	Chiba University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Chiba University Hospital Clinical Research Center
Address	1-8-1 inohana chuo-ku chiba-city CHIBA
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	2020 Year 02 Month 26 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	Completed
Date of protocol fixation	2020 Year 01 Month 20 Day
Date of IRB	2019 Year 11 Month 18 Day
Anticipated trial start date	2020 Year 02 Month 28 Day
Last follow-up date	2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 02 Month 26 Day
Last modified on	2022 Year 10 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045028