UMIN-CTR Clinical Trial

Public title

An Exploratory Intervention Study to Evaluate the Improvement of Psychological Stress in Families of Adolescents with hikikomori by Telemedicine Consultation

Acronym

An Exploratory Study on Psychological Support for Families of Adolescents with hikikomori by Telemedicine Consultation

Scientific Title

An Exploratory Intervention Study to Evaluate the Improvement of Psychological Stress in Families of Adolescents with hikikomori by Telemedicine Consultation

Scientific Title:Acronym

An Exploratory Study on Psychological Support for Families of Adolescents with hikikomori by Telemedicine Consultation

Region

Japan

Condition

Psychological stress in families of adolescents with hikikomori

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to explore the differences between telehealth medical consultations for families of adolescents with hikikomori and conventional in-person family consultations by using quasi-experimental methods to measure, respectively, changes in family psychological stress and sense of difficulty in each group due to telehealth medical consultations and conventional in-person health medical consultations, the rate of achievement of conducting medical evaluations for hikikomori. Then, this study explores the differences in the rate of accomplishment of medical evaluation, family satisfaction, and subsequent changes in social functioning of the socially withdrawn parties in the telehealth medical consultation and conventional face-to-face medical consultation groups, and examines their practicality.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Amount of change in psychological stress in families with withdrawn adolescents

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Intervention: Online telehealth medical consultation

Interventions/Control_2

Control: Face-to-face health medical consultation in the form of in-person meetings

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

18

years-old

<=

Age-upper limit

99

years-old

>=

Gender

Male and Female

Key inclusion criteria

The following family members of adolescents with hikikomori are eligible for the program. The family members of socially withdrawn persons must be at least 18 years old and have no previous experience of medical consultation.
Family members of adolescents with hikikomori between the ages of 15 and 39 who have been judged as needing medical consultation by the Yokohama Youth Consultation Center and its related support organizations. Subjects will be recruited from announcements within and outside of the social withdrawal support organizations in each area of residence of adolescents with hikikomori at the Yokohama Municipal Youth Counseling Center. The center is a facility where the principal investigator and co-investigator regularly work as contracted physicians, so they will receive regular reports on the availability of those who wish to be consulted. Those who wish to consult will receive access to an online interview with the principal investigator, which will be held at a designated time and explained to them. The status of the withdrawn parties, regardless of severity, will be considered as meeting the definition of "hikikomori" or "pre-hikikomori" as defined by international diagnostic criteria and will be included if the following conditions are met
(1) The age of the withdrawn person is between 15 and 39 years old at the time consent is obtained.
(2) The family members who have received a full explanation of the study before the start of the interview, and who have given their free and voluntary written consent based on a full understanding of the study.
3) Family members who are able to use communication devices for this study.
In the case of a married couple or a parent-child relationship, one of the family members is considered the "subject of this study" and the other is considered the "participant.

Key exclusion criteria

Persons who meet any of the following conditions will be excluded from the study because of the potential for ethical problems and significant differences in the backgrounds of the groups. The following possibilities will be identified during the recruitment and interview process
1) Family members who are seriously abusive (physical, psychological, sexual abuse, and neglect) toward the withdrawn person.
2) Families who have no daily experience using the Internet
3) Families who have difficulty in understanding due to old age, dementia, etc.
4) The hikikomori person is already receiving treatment at a different medical institution, and his/her physician in charge raises concerns about participation in the study.
5) Cases in which the withdrawn person is significantly emotionally disturbed by the family member's counseling behavior.

Target sample size

40

Name of lead principal investigator

1st name	Junichi
Middle name
Last name	Fujita

Organization

Yokohama City University Hospital

Division name

Department of child psychiatry

Zip code

2360004

Address

3-9, Fukuura Kanazawa-ku, Yokohama city

TEL

0457872800

Email

jun1182@yokohama-cu.ac.jp

Name of contact person

1st name	Akira
Middle name
Last name	Suda

Organization

Yokohama City University

Division name

Department of psychiatry

Zip code

2360004

Address

3-9, Fukuura Kanazawa-ku, Yokohama city

TEL

0457872800

Homepage URL

Email

sudaakira_ycu@yahoo.co.jp

Institute

Yokohama City University

Institute

Department

Personal name

Organization

Grants-in-Aid for Scientific Research

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Yokohama City University

Address

1-1-1, Fukuura Kanazawa-ku, Yokohama city

Tel

045-370-7949

Email

ynextedu@yokohama-cu.ac.jp

Secondary IDs

YES

Study ID_1

F220407002

Org. issuing International ID_1

Yokohama City University

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

横浜市立大学附属病院（神奈川県）、横浜市立大学附属市民総合医療センター（神奈川県）

Date of disclosure of the study information

2022

Year

07

Month

01

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

Enrolling by invitation

Date of protocol fixation

2022

Year

06

Month

24

Day

Date of IRB

2022

Year

06

Month

24

Day

Anticipated trial start date

2022

Year

10

Month

01

Day

Last follow-up date

2026

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

06

Month

28

Day

Last modified on

2023

Year

01

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054915