ADHDNCT06352801
Effectiveness of Self-Compassion Intervention on Enhancing Self-Compassion and Psychological Well-Being of Children With Attention Deficit/Hyperactivity Disorder
A study testing Self-Compassion Intervention in people with ADHD and Self-Compassion, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The study aims to investigate the underlying mechanism between Attention Deficit/Hyperactivity Disorder traits (AD/HD traits) and psychological well-being through studying the role of perceived criticism, rejection sensitivity, self-compassion and growth mindset. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD, Self-Compassion, Psychological Well-Being
- What is being tested?
- Self-Compassion Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteHong Kong
- Study dates
- 28 Dec 2023to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Upper primary students
- Clinical diagnosis, suspected cases of AD/HD, or having AD/HD symptoms
- Able to read, write and communicate in Chinese
Who cannot join
- Hearing, visual, or physical impairments that might hinder participation in the intervention
- Clinical diagnosis and suspected cases of Autism Spectrum Disorder (ASD)
- Prior or current participation in a psychotherapeutic treatment
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to investigate the underlying mechanism between Attention Deficit/Hyperactivity Disorder traits (AD/HD traits) and psychological well-being through studying the role of perceived criticism, rejection sensitivity, self-compassion and growth mindset. It also aims to explore the effectiveness of self-compassion intervention on enhancing self-compassion and psychological well-being of children with AD/HD in Hong Kong. The study will contribute to the current understanding of the supportive measures for children with AD/HD, and hopefully help to mobilize more resources to preserve children with AD/HD's mental health.
The intervention program includes the following components:
Read more
Participants will be randomly assigned to the self-compassion intervention group or the waitlist control group. The intervention group consists of two parts: children training session and parent group sessions. All children participants will complete a total of 6 training sessions, and each session will last around 90 minutes. Parents of the children participants will also complete a total of 3 group sessions, and each session will last around 90 minutes.
To investigate the intervention effectiveness, children will be asked to complete a questionnaire assessing their levels of self-compassion, emotional regulation, as well as psychological well-being in terms of life satisfaction, positive and negative affect. Parents and teachers of participants will also be asked to complete a questionnaire covering children's emotional regulation, positive and negative affect. Questionnaire data collection will be conducted prior to the intervention (i.e., Time 1), immediately after the 6-session student and 3-session parent sessions (i.e., Time 2), and 2 months after the intervention (i.e., Time 3, a 2-month follow up). It takes approximately 20-30 minutes for children and parents to complete their questionnaires.
Study Objectives:
- To investigate the underlying mechanism of the relationship between AD/HD traits and psychological well-being
- To explore the effectiveness of self-compassion intervention on enhancing self-compassion and psychological well-being of children with AD/HD in Hong Kong
Hypotheses:
- AD/HD traits negatively predicts psychological well-being
- AD/HD traits positively predicts perceived criticism or rejection sensitivity
- Perceived criticism or rejective sensitivity negatively predicts psychological well-being
- Perceived criticism or rejective sensitivity mediates the relationship between AD/HD traits and psychological well-being
- Self-compassion moderates the relationship between perceived criticism or rejection sensitivity and psychological well-being
- Growth mindset moderates the relationship between perceived criticism or rejection sensitivity and psychological well-being
- Children with AD/HD from self-compassion intervention group yield greater improvement in self-compassion, emotional regulation and psychological well-being, than waitlist-control group.
- Conditions
- ADHD, Self-Compassion, Psychological Well-Being
- Being tested
- Self-Compassion Intervention
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Compassion InterventionBehavioural
Also called My DEER Compassion
Children participants are expected to learn the concepts of self-compassion and strategies of applying self-compassion to their daily lives.
| Study group | Role | What they receive |
|---|---|---|
| Self-Compassion Intervention Group | Experimental | The intervention group consists of two parts: children training session and parent group sessions. All children participants will complete a total of 6 training sessions, and each session will last around 90 minutes. Parents of the children participants will also complete a total of 3 group sessions, and each session will last around 90 minutes. Participants will receive intervention in Phase 1. Receives: Behavioral: Self-Compassion Intervention |
| Wait-list Control Group | No intervention | Participants will receive the same intervention in Phase 2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Compassion Scale for Children (SCS-C)
A scale consisting of 12 self-report items assessing children's self-compassion [Min. Value: 1; Max Value: 5 (with higher score indicating higher level of self-compassion)]
Measured: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
Self-Compassion Scale for Children (SCS-C)
A scale consisting of 12 self-report items assessing children's self-compassion [Min. Value: 1; Max Value: 5 (with higher score indicating higher level of self-compassion)]
Measured: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
Self-Compassion Scale for Children (SCS-C)
A scale consisting of 12 self-report items assessing children's self-compassion [Min. Value: 1; Max Value: 5 (with higher score indicating higher level of self-compassion)]
Measured: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Behavioural ratings on children's executive functions
Parents and teachers will be asked to complete Behaviour Rating Inventory of Executive Function, Second Edition (BRIEF2) measuring a range of executive functions, including emotional regulation [Min. Value: 1; Max Value: 4 (with higher score indicating higher level of emotional regulation)]
Measured: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
Behavioural ratings on children's executive functions
Parents and teachers will be asked to complete Behaviour Rating Inventory of Executive Function, Second Edition (BRIEF2) measuring a range of executive functions, including emotional regulation [Min. Value: 1; Max Value: 4 (with higher score indicating higher level of emotional regulation)]
Measured: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
Behavioural ratings on children's executive functions
Parents and teachers will be asked to complete Behaviour Rating Inventory of Executive Function, Second Edition (BRIEF2) measuring a range of executive functions, including emotional regulation [Min. Value: 1; Max Value: 4 (with higher score indicating higher level of emotional regulation)]
Measured: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Student's Life Satisfaction Scale (SLSS)
A scale consisting of 7 self-report items assessing children's life satisfaction [Min. Value: 1; Max Value: 6 (with higher score indicating higher level of life satisfaction)]
Measured: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
Student's Life Satisfaction Scale (SLSS)
A scale consisting of 7 self-report items assessing children's life satisfaction [Min. Value: 1; Max Value: 6 (with higher score indicating higher level of life satisfaction)]
Measured: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
Student's Life Satisfaction Scale (SLSS)
A scale consisting of 7 self-report items assessing children's life satisfaction [Min. Value: 1; Max Value: 6 (with higher score indicating higher level of life satisfaction)]
Measured: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Positive and Negative Affect Schedule for Children (PANAS-C/P)
The PANAS, is a self-reported adjective checklist that contains two 5-item subscales designed to measure positive and negative affect. Children, parents and teachers will be asked to complete the scale [Min. Value: 1; Max Value: 5 (with higher score indicating higher level of positive and negative affect)]
Measured: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
Positive and Negative Affect Schedule for Children (PANAS-C/P)
The PANAS, is a self-reported adjective checklist that contains two 5-item subscales designed to measure positive and negative affect. Children, parents and teachers will be asked to complete the scale [Min. Value: 1; Max Value: 5 (with higher score indicating higher level of positive and negative affect)]
Measured: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
Positive and Negative Affect Schedule for Children (PANAS-C/P)
The PANAS, is a self-reported adjective checklist that contains two 5-item subscales designed to measure positive and negative affect. Children, parents and teachers will be asked to complete the scale [Min. Value: 1; Max Value: 5 (with higher score indicating higher level of positive and negative affect)]
Measured: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start28 Dec 2023
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention Group: In Phase 1, children participants receive a 6-session self-compassion intervention training, plus parents of the participants receive a 3-session parent group. once to twice a week, 90 minutes per session. Wait-list Control: receives the same intervention in Phase 2
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352801
- Sponsor's protocol ID
- EA230530
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2024
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Downey G, Lebolt A, Rinco´n C, Freitas AL (1998) Rejection sensitivity and children's interpersonal Dweck, C. S. (1999). Self-theories: Their Role in Motivation, Personality, and Development. Psychology Press. Ebesutani, C., Regan, J., Smith, A., Reise, S., Higa-McMillan, C., & Chorpita, B. F. (2012). The 10-item positive and negative affect schedule for children, child and parent shortened versions: application of item response theory for more efficient assessment. Journal of Psychopathology and Behavioural Assessment, 34, 191-203. Hooley, J. M., & Teasdale, J. D. (1989). Predictors of relapse in unipolar depressives: expressed emotion, marital distress, and perceived criticism. Journal of Abnormal Psychology, 98(3), 229. Huebner, E. S. (1991). Initial development of the student's life satisfaction scale. School Psychology International, 12(3), 231-240. Lai, K. Y., Leung, P. W., Luk, E. S., Wong, A. S., Law, L. S., & Ho, K. K. (2013). Validation of the Chinese strengths and weaknesses of ADHD-symptoms and normal-behaviours questionnaire in Hong Kong. Journal of Attention Disorders, 17(3), 194-202. Raes, F. (2010). Ruminating and worrying as mediators of the relationship between self-compassion and anxiety and ' depression. Personality and Individual Differences, 48, 757-761.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Self-Compassion Intervention on Enhancing Self-Compassion and Psychological Well-Being of Children With Attention Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT06352801
- Acronym / sponsor ID
- EA230530
- Conditions
- ADHD, Self-Compassion, Psychological Well-Being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 28 Dec 2023 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to investigate the underlying mechanism between Attention Deficit/Hyperactivity Disorder traits (AD/HD traits) and psychological well-being through studying the role of perceived criticism, rejection sensitivity, self-compassion and growth mindset. It also aims to explore the effectiveness of self-compassion intervention on enhancing self-compassion and psychological well-being of children with AD/HD in Hong Kong. The study will contribute to the current understanding of the supportive measures for children with AD/HD, and hopefully help to mobilize more resources to preserve children with AD/HD's mental health.
The intervention program includes the following components:
Participants will be randomly assigned to the self-compassion intervention group or the waitlist control group. The intervention group consists of two parts: children training session and parent group sessions. All children participants will complete a total of 6 training sessions, and each session will last around 90 minutes. Parents of the children participants will also complete a total of 3 group sessions, and each session will last around 90 minutes.
To investigate the intervention effectiveness, children will be asked to complete a questionnaire assessing their levels of self-compassion, emotional regulation, as well as psychological well-being in terms of life satisfaction, positive and negative affect. Parents and teachers of participants will also be asked to complete a questionnaire covering children's emotional regulation, positive and negative affect. Questionnaire data collection will be conducted prior to the intervention (i.e., Time 1), immediately after the 6-session student and 3-session parent sessions (i.e., Time 2), and 2 months after the intervention (i.e., Time 3, a 2-month follow up). It takes approximately 20-30 minutes for children and parents to complete their questionnaires.
Study Objectives:
- To investigate the underlying mechanism of the relationship between AD/HD traits and psychological well-being
- To explore the effectiveness of self-compassion intervention on enhancing self-compassion and psychological well-being of children with AD/HD in Hong Kong
Hypotheses:
- AD/HD traits negatively predicts psychological well-being
- AD/HD traits positively predicts perceived criticism or rejection sensitivity
- Perceived criticism or rejective sensitivity negatively predicts psychological well-being
- Perceived criticism or rejective sensitivity mediates the relationship between AD/HD traits and psychological well-being
- Self-compassion moderates the relationship between perceived criticism or rejection sensitivity and psychological well-being
- Growth mindset moderates the relationship between perceived criticism or rejection sensitivity and psychological well-being
- Children with AD/HD from self-compassion intervention group yield greater improvement in self-compassion, emotional regulation and psychological well-being, than waitlist-control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention Group: In Phase 1, children participants receive a 6-session self-compassion intervention training, plus parents of the participants receive a 3-session parent group. once to twice a week, 90 minutes per session. Wait-list Control: receives the same intervention in Phase 2
| Arm | Type | Receives |
|---|---|---|
| Self-Compassion Intervention Group | Experimental | Behavioral: Self-Compassion InterventionThe intervention group consists of two parts: children training session and parent group sessions. All children participants will complete a total of 6 training sessions, and each session will last around 90 minutes. Parents of the children participants will also complete a total of 3 group sessions, and each session will last around 90 minutes. Participants will receive intervention in Phase 1. |
| Wait-list Control Group | No intervention | –Participants will receive the same intervention in Phase 2. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Upper primary students
- Clinical diagnosis, suspected cases of AD/HD, or having AD/HD symptoms
- Able to read, write and communicate in Chinese
Key exclusion criteria (3 listed)
- Hearing, visual, or physical impairments that might hinder participation in the intervention
- Clinical diagnosis and suspected cases of Autism Spectrum Disorder (ASD)
- Prior or current participation in a psychotherapeutic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Compassion InterventionAlso: My DEER CompassionChildren participants are expected to learn the concepts of self-compassion and strategies of applying self-compassion to their daily lives. | Behavioural | Self-Compassion Intervention Group |
Primary outcome
Self-Compassion Scale for Children (SCS-C)
Time frame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
A scale consisting of 12 self-report items assessing children's self-compassion [Min. Value: 1; Max Value: 5 (with higher score indicating higher level of self-compassion)]
Self-Compassion Scale for Children (SCS-C)
Time frame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
A scale consisting of 12 self-report items assessing children's self-compassion [Min. Value: 1; Max Value: 5 (with higher score indicating higher level of self-compassion)]
Self-Compassion Scale for Children (SCS-C)
Time frame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
A scale consisting of 12 self-report items assessing children's self-compassion [Min. Value: 1; Max Value: 5 (with higher score indicating higher level of self-compassion)]
Behavioural ratings on children's executive functions
Time frame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
Parents and teachers will be asked to complete Behaviour Rating Inventory of Executive Function, Second Edition (BRIEF2) measuring a range of executive functions, including emotional regulation [Min. Value: 1; Max Value: 4 (with higher score indicating higher level of emotional regulation)]
Behavioural ratings on children's executive functions
Time frame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
Parents and teachers will be asked to complete Behaviour Rating Inventory of Executive Function, Second Edition (BRIEF2) measuring a range of executive functions, including emotional regulation [Min. Value: 1; Max Value: 4 (with higher score indicating higher level of emotional regulation)]
Behavioural ratings on children's executive functions
Time frame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Parents and teachers will be asked to complete Behaviour Rating Inventory of Executive Function, Second Edition (BRIEF2) measuring a range of executive functions, including emotional regulation [Min. Value: 1; Max Value: 4 (with higher score indicating higher level of emotional regulation)]
Student's Life Satisfaction Scale (SLSS)
Time frame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
A scale consisting of 7 self-report items assessing children's life satisfaction [Min. Value: 1; Max Value: 6 (with higher score indicating higher level of life satisfaction)]
Student's Life Satisfaction Scale (SLSS)
Time frame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
A scale consisting of 7 self-report items assessing children's life satisfaction [Min. Value: 1; Max Value: 6 (with higher score indicating higher level of life satisfaction)]
Student's Life Satisfaction Scale (SLSS)
Time frame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
A scale consisting of 7 self-report items assessing children's life satisfaction [Min. Value: 1; Max Value: 6 (with higher score indicating higher level of life satisfaction)]
Positive and Negative Affect Schedule for Children (PANAS-C/P)
Time frame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
The PANAS, is a self-reported adjective checklist that contains two 5-item subscales designed to measure positive and negative affect. Children, parents and teachers will be asked to complete the scale [Min. Value: 1; Max Value: 5 (with higher score indicating higher level of positive and negative affect)]
Positive and Negative Affect Schedule for Children (PANAS-C/P)
Time frame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
The PANAS, is a self-reported adjective checklist that contains two 5-item subscales designed to measure positive and negative affect. Children, parents and teachers will be asked to complete the scale [Min. Value: 1; Max Value: 5 (with higher score indicating higher level of positive and negative affect)]
Positive and Negative Affect Schedule for Children (PANAS-C/P)
Time frame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
The PANAS, is a self-reported adjective checklist that contains two 5-item subscales designed to measure positive and negative affect. Children, parents and teachers will be asked to complete the scale [Min. Value: 1; Max Value: 5 (with higher score indicating higher level of positive and negative affect)]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- BackgroundDowney G, Lebolt A, Rinco´n C, Freitas AL (1998) Rejection sensitivity and children's interpersonal Dweck, C. S. (1999). Self-theories: Their Role in Motivation, Personality, and Development. Psychology Press. Ebesutani, C., Regan, J., Smith, A., Reise, S., Higa-McMillan, C., & Chorpita, B. F. (2012). The 10-item positive and negative affect schedule for children, child and parent shortened versions: application of item response theory for more efficient assessment. Journal of Psychopathology and Behavioural Assessment, 34, 191-203. Hooley, J. M., & Teasdale, J. D. (1989). Predictors of relapse in unipolar depressives: expressed emotion, marital distress, and perceived criticism. Journal of Abnormal Psychology, 98(3), 229. Huebner, E. S. (1991). Initial development of the student's life satisfaction scale. School Psychology International, 12(3), 231-240. Lai, K. Y., Leung, P. W., Luk, E. S., Wong, A. S., Law, L. S., & Ho, K. K. (2013). Validation of the Chinese strengths and weaknesses of ADHD-symptoms and normal-behaviours questionnaire in Hong Kong. Journal of Attention Disorders, 17(3), 194-202. Raes, F. (2010). Ruminating and worrying as mediators of the relationship between self-compassion and anxiety and ' depression. Personality and Individual Differences, 48, 757-761.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Compassion Intervention in people with ADHD and Self-Compassion, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Compassion Scale for Children (SCS-C) (time frame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06352801, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.