Tokyo, June 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061990) titled 'Study of the .b (Dot-be) Adolescent Mindfulness Program for Parents and Teachers' on June 21.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Kansai Medical University
Condition:
Condition - Healthy adults (parents and teachers of adolescents)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Parents and teachers who wish to participate in the .b (pronounced "Dot-be"), a 9-week (10-session) mindfulness program for adolescents developed in the United Kingdom, will be randomly assigned to either an immediate intervention group or a wait-list control group. The effectiveness of the program will be explored by comparing changes in self-reported questionnaire outcomes between the two groups.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Mindfulness
Interventions/Control_2 - Waitlist control
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Participants must meet all of the following inclusion criteria:
1. Individuals who wish to participate after attending an information session or viewing a recorded information session.
2. Individuals who are able to attend at least the first four sessions of the 9-session program (1 hour per week).
3. Individuals who are willing to undertake approximately 10 minutes of home mindfulness practice per day on at least 6 of every 7 days.
4. Individuals who agree to complete the study questionnaires before and after the program and consent to the publication of anonymized study results in accordance with personal information protection regulations.
5. No restrictions on age or sex.
6. Individuals who have received a full explanation of the study, have adequately understood the study procedures, and have provided written informed consent voluntarily.
Key exclusion criteria - Individuals meeting any of the following exclusion criteria will not be enrolled in the study:
1. Individuals who have previously completed an 8-week mindfulness program.
2. Individuals with social anxiety or other conditions that would interfere with participation in the program.
3. Individuals considered by the instructors or the principal investigator to be unsuitable for participation for any other reason.
Target Size - 120
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 06 Month 19 Day
Date of IRB - 2026 Year 06 Month 19 Day
Anticipated trial start date - 2026 Year 07 Month 01 Day
Last follow-up date - 2027 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070935
Disclaimer: Curated by HT Syndication.