Clinical trial NCT06352801: Effectiveness of Self-Compassion Intervention on Enhancing Self-Compassion and Psychological Well-Being of Children With Attention Deficit/Hyperactivity Disorder
Official title: Effectiveness of Self-Compassion Intervention on Enhancing Self-Compassion and Psychological Well-Being of Children With Attention Deficit/Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ADHD
Self-Compassion
Psychological Well-Being
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 100
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Self-Compassion Scale for Children (SCS-C)
timeFrame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
measure: Self-Compassion Scale for Children (SCS-C)
timeFrame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
measure: Self-Compassion Scale for Children (SCS-C)
timeFrame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
measure: Behavioural ratings on children's executive functions
timeFrame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
measure: Behavioural ratings on children's executive functions
timeFrame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
measure: Behavioural ratings on children's executive functions
timeFrame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
measure: Student's Life Satisfaction Scale (SLSS)
timeFrame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
measure: Student's Life Satisfaction Scale (SLSS)
timeFrame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
measure: Student's Life Satisfaction Scale (SLSS)
timeFrame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
measure: Positive and Negative Affect Schedule for Children (PANAS-C/P)
timeFrame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
measure: Positive and Negative Affect Schedule for Children (PANAS-C/P)
timeFrame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
measure: Positive and Negative Affect Schedule for Children (PANAS-C/P)
timeFrame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Secondary outcomes:
Other outcomes:
measure: The Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior Scale (SWAN)
timeFrame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
measure: The Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior Scale (SWAN)
timeFrame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
measure: The Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior Scale (SWAN)
timeFrame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
measure: The Perceived Criticism Scale (PCS)
timeFrame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
measure: The Perceived Criticism Scale (PCS)
timeFrame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
measure: The Perceived Criticism Scale (PCS)
timeFrame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
measure: Children's Rejection Sensitivity Questionnaire (CRSQ)
timeFrame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
measure: Children's Rejection Sensitivity Questionnaire (CRSQ)
timeFrame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
measure: Children's Rejection Sensitivity Questionnaire (CRSQ)
timeFrame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
measure: Growth Mindset Scale
timeFrame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention
measure: Growth Mindset Scale
timeFrame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)]
measure: Growth Mindset Scale
timeFrame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
References:
citation: 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.