UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061990 |
|---|---|
| Receipt number | R000070935 |
| Scientific Title | Expanded Evaluation of the Effectiveness of the .b (Dot-be) Adolescent Mindfulness Program for Parents and Teachers: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/06/21 |
| Last modified on | 2026/06/21 12:09:15 |
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Basic information
Public title
Study of the .b (Dot-be) Adolescent Mindfulness Program for Parents and Teachers
Acronym
.b Parents & Teachers Study (.b-PTS)
Scientific Title
Expanded Evaluation of the Effectiveness of the .b (Dot-be) Adolescent Mindfulness Program for Parents and Teachers: A Randomized Controlled Trial
Scientific Title:Acronym
.b-PT RCT
Region
| Japan |
Condition
Condition
Healthy adults (parents and teachers of adolescents)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
to evaluate the effectiveness of the program in a broader population of parents and teachers, delivered by a larger group of instructors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome measures are changes from baseline to post-intervention in mindfulness, self-compassion, mood profile, health-related quality of life, perceived stress, and the parent-child relationship, as assessed using validated self-report questionnaires. The secondary outcome measures include changes over time at the 5-month follow-up (3 months after completion of the program), the association between participants' outcomes and the level of instructor experience, and responses to a post-intervention questionnaire.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Mindfulness
Interventions/Control_2
Waitlist control
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
| 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 sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Ito |
Organization
Kansai Medical University
Division name
Department of Psychosomatic Medicine
Zip code
573-1010
Address
2-5-1 Shin-machi, Hirakata, Osaka, Japan
TEL
072-804-0101
yasushi_ito@mbsrjapan.com
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Ito |
Organization
Kansai Medical University
Division name
Department of Psychosomatic Medicine
Zip code
655-0017
Address
2-5-1 Shin-machi, Hirakata, Osaka, Japan
TEL
072-804-0101
Homepage URL
yasushi_ito@mbsrjapan.com
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
Department of Psychosomatic Medicine, Kansai Medical University
Address
2-5-1 Shin-machi, Hirakata, Osaka 573-1010, Japan
Tel
072-804-0101
yasushi_ito@mbsrjapan.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
| 2026 | Year | 06 | Month | 21 | 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
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 21 | Day |
Last modified on
| 2026 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070935
