UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057167 |
|---|---|
| Receipt number | R000057601 |
| Scientific Title | The effectiveness of coaching as a support measure for adult ADHD patients : A quantitative and qualitative study aiming to verify clinical effecs. |
| Date of disclosure of the study information | 2025/03/01 |
| Last modified on | 2025/02/28 11:37:49 |
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Basic information
Public title
Is Coaching an Effective Support Strategy for Adult ADHD Patients Attending Psychiatric Clinics?
Acronym
The Effectiveness of Coaching for Adults ADHD patients.
Scientific Title
The effectiveness of coaching as a support measure for adult ADHD patients : A quantitative and qualitative study aiming to verify clinical effecs.
Scientific Title:Acronym
The Effectiveness of Coaching for Adults ADHD patients.
Region
| Japan |
Condition
Condition
Attention Deficit/Hyperactivity Disorder
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Improvement and enhancement of daily living skills in adult ADHD patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Occurrence frequency of Appropriate behavior (desired behavior in daily life).
Key secondary outcomes
Questionnaire scale, SDS, STAI-JYZ, WHOQOL26, SWBS. Conducted before and after the intervention, as well as at the follow-up.
Verbatim records of interviews and other interactions were collected from the beginning to the end of the program.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention: coaching based on the theoretical model of coaching psychology.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
(1) Patients attending the collaborating institution who meet the following conditions.
Extraction target period: April 1, 2022
Persons 20 years of age or older diagnosed with ADHD
In principle, those who have completed the following tests (WAIS-4, A-ADHD, ASRS, CAARS, AQ, and A-ASD)
Individuals whose intellectual ability in the WAIS-4 intelligence tests is in the average range (FSIQ: 85 or higher)
(2) Those who agree with the purpose and significance of the research and are able to cooperate with regular reports during the research period.
Key exclusion criteria
(1) Subjects with severe depression/anxiety tendencies
(2) Subjects with serious suicidal tendencies in the past 3 months
(3) Those who are receiving treatment for substance dependence such as drugs
(4) Those who are receiving support from other organizations.
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Yuhei |
| Middle name | |
| Last name | Hatakenaka |
Organization
UNIVERSITY OF THE RYUKYUS
Division name
Faculty of Humanities and Social Sciences, University of the Ryukyus
Zip code
9030213
Address
Chihara, Nishihara Town, Nakagami District, Okinawa Prefecture, Japan
TEL
098-895-9053
yuheih@hs.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Katsura |
| Middle name | |
| Last name | Matsumura |
Organization
UNIVERSITY OF THE RYUKYUS
Division name
Graduate School of community Engagement and development, University of the Ryukyus
Zip code
9030213
Address
Chihara, Nishihara Town, Nakagami District, Okinawa Prefecture, Japan
TEL
098-895-9053
Homepage URL
k229236@eve.u-ryukyu.ac.jp
Sponsor or person
Institute
Faculty of Humanities and Social Sciences, University of the Ryukyus. Yuhei hatakenaka.
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
Ryukyu University Research Ethics Committee for Life Sciences and Medical Research Involving Human Subjects.
Address
Chihara, Nishihara Town, Nakagami District, Okinawa Prefecture, Japan
Tel
098-895-1543
krinken@acs.u-ryukyu.ac.jp
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
| 2025 | Year | 03 | Month | 01 | 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
5
Results
This intervention was based on the theoretical model of coaching psychology and utilized a unique program developed specifically for this study.
The results of this study showed an increase in desirable behaviors (target behaviors) and a decrease in undesirable behaviors among all five participants. Additionally, many participants exhibited reductions in depressive and anxiety tendencies, along with improvements in subjective well-being and quality of life.
Results date posted
| 2025 | Year | 02 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Adult ADHD patients attending a psychiatric clinic
Participant flow
Adverse events
During the study period, no adverse events occurred. The schedule was adjusted according to each participant's requests, and the program was conducted while regularly checking their physical condition at each session.
Outcome measures
A convergent mixed-methods design was employed to comprehensively examine the effectiveness of the intervention by integrating quantitative and qualitative data analysis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 28 | Day |
Last modified on
| 2025 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057601
