Tokyo, Nov. 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059911) titled 'A randomized controlled trial of Community Reinforcement and Family Training (CRAFT) for social withdrawal (Hikikomori)' on Nov. 28.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Sapporo Gakuin University

Condition: Condition - Social Withdrawal (Hikikomori) Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

Eligibility: 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 Size - 28

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068510

Disclaimer: Curated by HT Syndication.