UMIN-ICDS Clinical Trial

Public title

A randomized controlled trial of Community Reinforcement and Family Training (CRAFT) for social withdrawal (Hikikomori)

Acronym

RCT of CRAFT for Hikikomori

Scientific Title

A randomized controlled trial of Community Reinforcement and Family Training (CRAFT) for social withdrawal (Hikikomori)

Scientific Title:Acronym

A randomized controlled trial of Community Reinforcement and Family Training (CRAFT) for social withdrawal (Hikikomori)

Region

Japan

Condition

Social Withdrawal (Hikikomori)

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Community Reinforcement and Family Training (CRAFT), which is used for families of individuals with substance use problems, has been proven effective and effectiveness in many countries. In Japan, CRAFT has been applied to support families of individuals with social withdrawal (Hikikomori), but no randomized controlled trials ensured the fidelity of the intervention have been conducted. In this study, families of individuals with social withdrawal (Hikikomori) are randomly assigned to a CRAFT group with the fidelity or a counseling as usual group, and effectiveness is compared between groups.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Outcomes are measured at three time points: Pre (before intervention/at the time of allocation: 0 week), Post (at the end of intervention: 12 Week), and Follow-up (8 weeks after the end of intervention: 20 Week).

Primary outcome: GHQ28 (The General Health Questionnaire 28) of family member (CSO) who comes to consult.

Key secondary outcomes

Secondary outcome 1 : Presence or absence of engagement of individual with social withdrawal (IP) with support facilities.
Secondary outcome 2 : Frequency of inappropriate behavior (violence, gaming addiction) of individual with social withdrawal (IP)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

In both the CRAFT group and the consultation group, a therapist see every two weeks for a total of six sessions, each session is 60 minutes. The difference between the interventions for the groups is as follows:
CRAFT group: Therapists who have attended a certified CRAFT workshop conduct CRAFT according to a standard text and receive supervision from a certified supervisor at least once a month.

Interventions/Control_2

Consultation group: Therapists who have attended a certified CRAFT workshop provide consultation support 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

Age-lower limit

15

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Individual (IP) who is in a state of social withdrawal (Hikikomori) is defined in a 2010 Ministry of Health, Labor and Welfare study as "a state in which, as a result of various factors, they have avoided social participation (schooling including compulsory education, employment including part-time work, socializing outside the home, etc.) and have generally remained at home for more than six months (although they may go out without interacting with others)"
2) Family member (CSO) who comes to the consultation is 18 years of age or older
3) IP is 15 years of age or older and have graduated from junior high school
4) CSO is first-degree relatives (parent, child, or sibling) of IP, intimate partner (married or unmarried), or close friend
5) CSO has had contact with IP at least 40% of the past 90 days (if they live together, this is met unconditionally. If they live apart, this is calculated by including phone, email, and social media contact in addition to face-to-face contact), and there are no expected changes in this relationship over the next 90 days
6) CSO and IP live within a two-hour travel time of a facility where sessions is provided, and have no plans to move outside the area within the next six months
7) CSO is able to provide informed consent
8) CSO is willing to participate in the study through informed consent

Key exclusion criteria

Exclusion Criteria
1) IP was enrolled in a special needs school
2) The intake officer determines CSO is physically and/or mentally inappropriate for the study
3) IP have received support or treatment for social withdrawal in the past month, or there is clear evidence that the IP is currently willing to receive support or treatment. Alternatively, IP is already receiving or scheduled to receive compulsory psychological support regardless of their will due to a criminal offense, the Juvenile Law, or the Mental Health and Welfare Act
4) CSO's reading comprehension skills is insufficient to understand the textbooks and psychological tests (they do not demonstrate reading comprehension as the level of junior high school graduation)

Discontinuation Criteria:
1) CSO declines to participate in the study or withdrew their consent
2) The study can not be continued due to CSO's and/or IP's circumstances, such as relocation
3) The entire study is discontinued
4) The principal researcher or therapist deem it appropriate to discontinue the study for other reasons

Target sample size

28

Name of lead principal investigator

1st name	Aya
Middle name
Last name	Yamamoto

Organization

Sapporo Gakuin University

Division name

Faculty of Psychology

Zip code

0048666

Address

1-1, Atubetsu Chuo 1jyo 5Chome, Atubetsu-Ku, Sapporo-Shi, Hokkaido, Japan

TEL

0113868111

Email

kuwaji@sgu.ac.jp

Name of contact person

1st name	Aya
Middle name
Last name	Yamamoto

Organization

Sapporo Gakuin University

Division name

Faculty of Psychology

Zip code

0048666

Address

1-1, Atubetsu Chuo 1jyo 5Chome, Atubetsu-Ku, Sapporo-Shi Hokkaido, Japan

TEL

0113868111

Homepage URL

Email

kuwaji@sgu.ac.jp

Institute

Sapporo Gakuin University

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology (MEXT)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Sapporo Gakuin University

Address

1-1, Atubetsu Chuo 1jyo 5Chome, Atubetsu-Ku, Sapporo-Shi, Hokkaido, Japan

Tel

0113868111

Email

kuwaji@sgu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2025

Year

11

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2025

Year

11

Month

28

Day

Date of IRB

2025

Year

11

Month

28

Day

Anticipated trial start date

2025

Year

11

Month

28

Day

Last follow-up date

2029

Year

05

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2025

Year

11

Month

28

Day

Last modified on

2025

Year

11

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068510