- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06352801
Effectiveness of Self-Compassion Intervention on Enhancing Self-Compassion and Psychological Well-Being of Children With Attention Deficit/Hyperactivity Disorder
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- The University of Hong Kong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Upper primary students
- Clinical diagnosis, suspected cases of AD/HD, or having AD/HD symptoms
- Able to read, write and communicate in Chinese
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Self-Compassion Intervention 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.
Participants will receive intervention in Phase 1.
|
Children participants are expected to learn the concepts of self-compassion and strategies of applying self-compassion to their daily lives.
Other Names:
|
|
No Intervention: Wait-list Control Group
Participants will receive the same intervention in Phase 2.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)]
|
Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
|
|
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)]
|
Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
|
|
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)]
|
Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
|
|
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)]
|
Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
|
|
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)]
|
Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
|
|
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)]
|
Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
|
|
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)]
|
Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
|
|
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)]
|
Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
|
|
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)]
|
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)
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)]
|
Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
|
|
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)]
|
Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
|
|
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)]
|
Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior Scale (SWAN)
Time Frame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
|
It is an 18- question parent or teacher rating scale to assess for the indication of attention-deficit hyperactivity disorder in children [Min.
Value: -3; Max Value: 3 (with lower score indicating higher level of AD/HD symptoms)]
|
Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
|
|
The Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior Scale (SWAN)
Time Frame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
|
It is an 18- question parent or teacher rating scale to assess for the indication of attention-deficit hyperactivity disorder in children [Min.
Value: -3; Max Value: 3 (with lower score indicating higher level of AD/HD symptoms)]
|
Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
|
|
The Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior Scale (SWAN)
Time Frame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
|
It is an 18- question parent or teacher rating scale to assess for the indication of attention-deficit hyperactivity disorder in children [Min.
Value: -3; Max Value: 3 (with lower score indicating higher level of AD/HD symptoms)]
|
Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
|
|
The Perceived Criticism Scale (PCS)
Time Frame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
|
The PCM is designed to provide a simple assessment of a family member's criticism from the perspective of the client/child [Min.
Value: 1; Max Value: 5 (with higher score indicating higher level of perceived criticism)]
|
Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
|
|
The Perceived Criticism Scale (PCS)
Time Frame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
|
The PCM is designed to provide a simple assessment of a family member's criticism from the perspective of the client/child [Min.
Value: 1; Max Value: 5 (with higher score indicating higher level of perceived criticism)]
|
Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
|
|
The Perceived Criticism Scale (PCS)
Time Frame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
|
The PCM is designed to provide a simple assessment of a family member's criticism from the perspective of the client/child [Min.
Value: 1; Max Value: 5 (with higher score indicating higher level of perceived criticism)]
|
Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
|
|
Children's Rejection Sensitivity Questionnaire (CRSQ)
Time Frame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
|
The Children's Rejection Sensitivity Questionnaire (CRSQ) was used to assess children's rejection sensitivity in terms of anxious or angry expectations of rejection [Min.
Value: 1; Max Value: 6 (with higher score indicating higher level of rejection sensitivity)]
|
Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
|
|
Children's Rejection Sensitivity Questionnaire (CRSQ)
Time Frame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
|
The Children's Rejection Sensitivity Questionnaire (CRSQ) was used to assess children's rejection sensitivity in terms of anxious or angry expectations of rejection [Min.
Value: 1; Max Value: 6 (with higher score indicating higher level of rejection sensitivity)]
|
Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
|
|
Children's Rejection Sensitivity Questionnaire (CRSQ)
Time Frame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
|
The Children's Rejection Sensitivity Questionnaire (CRSQ) was used to assess children's rejection sensitivity in terms of anxious or angry expectations of rejection [Min.
Value: 1; Max Value: 6 (with higher score indicating higher level of rejection sensitivity)]
|
Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
|
|
Growth Mindset Scale
Time Frame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
|
It is a 3-item Growth Mindset Scale to measure how much people believe that they can get smarter if they work at it The Children's Rejection Sensitivity Questionnaire (CRSQ) was used to assess children's rejection sensitivity in terms of anxious or angry expectations of rejection [Min.
Value: 1; Max Value: 6 (with higher score indicating higher level of growth mindset)]
|
Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
|
|
Growth Mindset Scale
Time Frame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
|
It is a 3-item Growth Mindset Scale to measure how much people believe that they can get smarter if they work at it The Children's Rejection Sensitivity Questionnaire (CRSQ) was used to assess children's rejection sensitivity in terms of anxious or angry expectations of rejection [Min.
Value: 1; Max Value: 6 (with higher score indicating higher level of growth mindset)]
|
Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
|
|
Growth Mindset Scale
Time Frame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
|
It is a 3-item Growth Mindset Scale to measure how much people believe that they can get smarter if they work at it The Children's Rejection Sensitivity Questionnaire (CRSQ) was used to assess children's rejection sensitivity in terms of anxious or angry expectations of rejection [Min.
Value: 1; Max Value: 6 (with higher score indicating higher level of growth mindset)]
|
Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EA230530
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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