An interventional study of Mindfulness Training Program and Psychosocial Education Program in Mindfulness Skills and Psychosocial Education, sponsored by Children's Hospital of Fudan University. Active, not recruiting at 1 site in China. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-01-15.
Sponsored by Children's Hospital of Fudan University · Not applicable, Interventional, and Treatment
This is a single-center, randomized, controlled intervention study designed to evaluate the effectiveness of mindfulness intervention on reducing body-focused repetitive behaviors (BFRBs) in children aged 8-18, such as nail-biting, skin-picking, and hair-pulling. Participants will be randomly assigned to either a mindfulness intervention group or a psychosocial education control group. The study aims to assess the impact of the intervention on the severity and frequency of BFRBs, psychological health outcomes such as anxiety and depression, and family dynamics. Data will be collected through standardized psychological assessments. The study's findings will contribute to understanding the role of mindfulness in managing BFRBs and improving emotional and familial well-being in children.
This study investigates the impact of mindfulness-based intervention (MBI) on children aged 8-18 with body-focused repetitive behaviors (BFRBs), including nail-biting, skin-picking, and hair-pulling. BFRBs often lead to psychological distress and impaired daily functioning. Current treatment options are limited, and mindfulness presents a promising non-invasive alternative. The study aims to evaluate the intervention's effectiveness in reducing BFRBs and improving psychological health and family dynamics. Participants will be randomized into two groups: a mindfulness intervention group and a psychosocial education control group. Both groups will participate in a 30-day program designed to address BFRBs, but with distinct approaches.
The mindfulness intervention group will engage in daily mindfulness exercises focusing on deep breathing, body scanning, emotional awareness, and behavior regulation for 10-15 minutes per day. The exercises are structured to build emotional awareness, manage impulses, and foster long-term emotional resilience. The program progresses through foundational mindfulness techniques, emotional acceptance, behavior modulation, and integrating mindfulness into daily life. Parents will actively participate by supervising and supporting their children's practice and recording their progress.
The psychosocial education control group will receive daily educational content designed to enhance emotional regulation and coping strategies. This content will be delivered via text and audio messages and will focus on improving emotional awareness, creating supportive home environments, and building healthy lifestyle habits. Parents will play a key role in implementing and supporting these strategies at home.
Baseline and follow-up assessments will be conducted to evaluate the intervention's effects on psychological health and family dynamics. Key measures include the frequency and severity of BFRBs as well as psychological health scales such as SCARED, CDI, OCI-CV ,s-EMBU-C and PHCSS. Parental mental health and family dynamics will also be assessed using validated tools, including the Conners Parent Rating Scale, SNAP-IV, PSI, and FAD. Assessments will be conducted at baseline (T0), immediately after the intervention (T1), and at a three-month follow-up (T2). Data analysis will focus on pre- and post-intervention comparisons to evaluate the mindfulness program's effectiveness in reducing BFRBs and improving emotional and family outcomes. Participants will be recruited from dermatology and psychiatric outpatient clinics at Children's Hospital of Fudan University . Recruitment will target children who have exhibited significant BFRBs within the last month, with informed consent obtained from their guardians.
Children's Hospital of Fudan University is the lead sponsor of 262 studies on the registry; 92 are open to participants now.
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Inclusion Criteria:（1）Children and adolescents aged 8 to 18 years. （2）Evidence of significant Body-Focused Repetitive Behaviors (BFRBs) such as nail-biting, skin-picking, or hair-pulling, observed within the last month.
（3）Written informed consent provided by the parent or legal guardian, and child assent provided by the participant.
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Exclusion Criteria:（1）Presence of severe physical illness or neurological disorders that may interfere with participation in the study.
（2）Participants currently receiving psychological interventions or pharmacological treatments for BFRBs or other psychiatric conditions, and who are unable to temporarily discontinue these treatments.
（3）Presence of significant cognitive impairment that would prevent the participant from completing study assessments or interventions.
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This group will receive a 30-day mindfulness intervention aimed at reducing Body-Focused Repetitive Behaviors (BFRBs) in children. The intervention includes daily mindfulness meditation exercises, such as deep breathing, body scans, and emotion awareness training, delivered via JD Health's platform. The children are encouraged to practice the exercises at home, with their parents providing support. The intervention is designed to improve emotional regulation, impulse control, and self-awareness in the participants. Assessments of behavioral and psychological outcomes will be collected at baseline, after one month, and at three months.
Behavioral: Mindfulness Training Program
This group will receive a 30-day psychosocial education intervention aimed at improving emotional regulation and coping skills in children with Body-Focused Repetitive Behaviors (BFRBs). Daily educational content, including articles and coping strategies, will be delivered through JD Health's platform. Parents will assist in supporting and encouraging their children to engage with the educational materials. The program focuses on promoting family support, emotional awareness, and behavioral strategies. Behavioral and psychological assessments will be conducted at baseline, after one month, and at three months.
Behavioral: Psychosocial Education Program
The Mindfulness Training Program is a 30-day behavioral intervention designed to help children with body-focused repetitive behaviors (BFRBs) such as nail-biting, skin-picking, and hair-pulling. Delivered through JD Health, the program includes daily audio-guided exercises focused on mindfulness techniques such as deep breathing, body scans, and emotional awareness. Children will be encouraged to practice mindfulness for 10-15 minutes each day, with the goal of improving emotional regulation, reducing impulsive behavior, and enhancing self-awareness. Family support is involved, with parents helping children track their progress and offering reinforcement.
The Psychosocial Education Program is a 30-day behavioral intervention designed for children with body-focused repetitive behaviors (BFRBs), including nail-biting, skin-picking, and hair-pulling. Delivered through JD Health, the program provides daily educational content in the form of articles and coping strategies. The intervention focuses on improving emotional regulation, promoting family support, and developing positive behavioral strategies. Parents play an active role by reviewing the content with their children and helping them apply the strategies in daily life. Behavioral and psychological assessments are conducted at baseline, one month, and three months to evaluate the program's impact.
Severity of Body-Focused Repetitive Behaviors (BFRBs) in Children as Reported by Parents
The primary outcome measure will assess the severity of body-focused repetitive behaviors (BFRBs) in children, as reported by parents using the custom-designed BFRBS questionnaire. This questionnaire evaluates the frequency, duration, and distress caused by behaviors such as nail biting, skin picking, and hair pulling. The goal is to measure changes in the frequency and severity of these behaviors over the course of the intervention (Mindfulness Training or Psychosocial Education), with assessments at baseline, 1 month, and 3 months.
Time frame: The primary outcome will be measured at baseline (pre-intervention), and at 1 month and 3 months after the intervention, based on parent assessments.
Severity of Body-Focused Repetitive Behaviors (BFRBs) in Children as Self-Reported by the Child
Children's self-reported experiences of BFRBs, including the frequency, duration, and distress, assessed through the custom-designed child version of the BFRBS questionnaire.
Time frame: Baseline, 1 month, 3 months
Children's Depression Inventory (CDI)
The CDI measures depressive symptoms in children, focusing on mood, behavior, and physical symptoms associated with depression. Scores range from 0 to 54, with higher scores indicating more severe depressive symptoms.
Time frame: Baseline (pre-intervention), 1 month post-intervention, 3 months post-intervention
Screen for Child Anxiety Related Emotional Disorders (SCARED)
The SCARED scale assesses the severity of anxiety symptoms in children, including subscales for separation anxiety, social phobia, generalized anxiety, panic, and specific fears. Scores range from 0 to 82, with higher scores indicating more severe anxiety symptoms.
Time frame: Baseline (pre-intervention), 1 month post-intervention, 3 months post-intervention
Piers-Harris Children's Self-Concept Scale (PHCSS)
The PHCSS measures children's self-concept, focusing on how they perceive themselves in domains such as behavior, emotions, and peer relationships. Scores range from 30 to 180, with higher scores indicating better self-concept and higher self-esteem.
Time frame: Baseline (pre-intervention), 1 month post-intervention, 3 months post-intervention
Obsessive-Compulsive Inventory - Child Version (OCI-CV)
The OCI-CV evaluates obsessive-compulsive behaviors in children, measuring both obsession and compulsion severity. Scores range from 0 to 36, with higher scores indicating more severe obsessive-compulsive behaviors.
Time frame: Baseline (pre-intervention), 1 month post-intervention, 3 months post-intervention
Short Form of the Egna Minnen Beträffande Uppfostran(s-EMBU)
The s-EMBU-C assesses children's perceptions of parental bonding and child-rearing practices, focusing on emotional support, rejection, and overprotection. Scores range from 1 to 5, with higher scores indicating better perceived parental bonding.
Time frame: Baseline (pre-intervention), 1 month post-intervention, 3 months post-intervention
Parenting Stress Index (PSI)
The Parenting Stress Index (PSI) assesses parental stress levels, focusing on areas such as child characteristics, parent characteristics, and the relationship between the parent and child. Scores range from 0 to 240, with higher scores indicating greater parental stress.
Time frame: Baseline (pre-intervention), 1 month post-intervention, 3 months post-intervention
Conners Parent Rating Scale
The Conners Parent Rating Scale is used to evaluate behaviors associated with Attention-Deficit/Hyperactivity Disorder (ADHD) in children. It includes a variety of behavioral and emotional issues that may indicate ADHD. Scores range from 0 to 60, with higher scores indicating more severe ADHD symptoms.
Time frame: Baseline (pre-intervention), 1 month post-intervention, 3 months post-intervention
Swanson, Nolan, and Pelham Teacher and Parent Rating Scale - Version IV (SNAP-IV)
The SNAP-IV scale measures attention and behavior issues, particularly related to ADHD. It is used to assess symptoms such as inattention, hyperactivity, and impulsivity, as observed by both parents and teachers. Scores range from 0 to 54, with higher scores indicating more severe attention and behavior issues.
Time frame: Baseline (pre-intervention), 1 month post-intervention, 3 months post-intervention
The Family Assessment Device (FAD)
FAD is a tool designed to assess family functioning, particularly focusing on communication and interaction patterns between family members. It evaluates various aspects of family life, such as communication, problem-solving, roles, affective involvement, behavior control, and general functioning. The FAD consists of 60 items, divided into several subscales that measure different aspects of family dynamics. The subscales include communication (the clarity and openness of communication between family members), problem-solving (the family's ability to resolve conflicts), roles (how responsibilities and roles are divided among family members), affective involvement (emotional support and connection between family members), behavioral control (discipline and structure), and general functioning (overall family cohesion and stability). Scores on the FAD range from 1 to 4, with higher scores indicating better family functioning and communication.
Time frame: Baseline (pre-intervention), 1 month post-intervention, 3 months post-intervention
Plan to share: Yes — Individual participant data (IPD) will be shared after publication of primary study results. Data will be de-identified to ensure participant confidentiality. Researchers can request access by submitting a proposal to the study team at \[email address\]. Approved researchers will receive access via a secure data-sharing platform.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Children's Hospital of Fudan University