Effectiveness of Self-Compassion Intervention on Enhancing Self-Compassion and Psychological Well-Being of Children With Attention Deficit/Hyperactivity Disorder

ADHD Clinical Trial

Official title:

Effectiveness of Self-Compassion Intervention on Enhancing Self-Compassion and Psychological Well-Being of Children With Attention Deficit/Hyperactivity Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06352801
• Other study ID #: EA230530
• Status: Recruiting
• Phase: N/A
• Start date: December 28, 2023
• Est. completion date: May 31, 2026

Study information

• Verified date: March 2024
• Source: The University of Hong Kong
• Contact: Kwan Lok TANG
• Phone: +852-66532947
• Email: tangkl1020[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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:

1. To investigate the underlying mechanism of the relationship between AD/HD traits and psychological well-being

2. 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:

1. AD/HD traits negatively predicts psychological well-being

2. AD/HD traits positively predicts perceived criticism or rejection sensitivity

3. Perceived criticism or rejective sensitivity negatively predicts psychological well-being

4. Perceived criticism or rejective sensitivity mediates the relationship between AD/HD traits and psychological well-being

5. Self-compassion moderates the relationship between perceived criticism or rejection sensitivity and psychological well-being

6. Growth mindset moderates the relationship between perceived criticism or rejection sensitivity and psychological well-being

7. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity
• Psychological Well-Being
• Self-Compassion

Intervention

Behavioral:
• Self-Compassion Intervention
Children participants are expected to learn the concepts of self-compassion and strategies of applying self-compassion to their daily lives.

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior Scale (SWAN)	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
Other	The Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior Scale (SWAN)	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)]
Other	The Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior Scale (SWAN)	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)
Other	The Perceived Criticism Scale (PCS)	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
Other	The Perceived Criticism Scale (PCS)	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)]
Other	The Perceived Criticism Scale (PCS)	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)
Other	Children's Rejection Sensitivity Questionnaire (CRSQ)	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
Other	Children's Rejection Sensitivity Questionnaire (CRSQ)	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)]
Other	Children's Rejection Sensitivity Questionnaire (CRSQ)	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)
Other	Growth Mindset Scale	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
Other	Growth Mindset Scale	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)]
Other	Growth Mindset Scale	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)
Primary	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)]	Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
Primary	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)]	Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
Primary	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)]	Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Primary	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)]	Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
Primary	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)]	Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
Primary	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)]	Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Primary	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)]	Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
Primary	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)]	Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
Primary	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)]	Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Primary	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)]	Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
Primary	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)]	Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
Primary	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)]	Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)