Mindfulness Intervention and Its Impact on Psychological and Family Dynamics in Children with Body-Focused Repetitive Behaviors.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Severity of Body-Focused Repetitive Behaviors (BFRBs) in Children as Reported by Parents
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
In this study, participants (children and their parents) will be unaware of the specific intervention group (Mindfulness Intervention or Psychosocial Education Control) they are assigned to after recruitment and consent. The random assignment to groups is managed entirely via the JingDong（JD） Health platform, and the interventions (daily mindfulness audio or psychosocial education articles) are delivered automatically through this platform. All outcome assessments (monthly and three-month follow-up surveys) will be conducted online via JD Health as well. Importantly, clinicians do not participate in the randomization, intervention delivery, or outcome assessments. Their role is limited to recruitment and initial consent collection. This ensures that clinicians are not involved in any part of the treatment or evaluation process, maintaining a fully masked design for participants and outcome assessors.
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •（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.
排除标准
- •（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.
研究组 & 干预措施
Mindfulness intervention Group
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.
干预措施: Mindfulness Training Program (Behavioral)
Psychosocial Education Control Group
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.
干预措施: Psychosocial Education Program (Behavioral)
结局指标
主要结局
Severity of Body-Focused Repetitive Behaviors (BFRBs) in Children as Reported by Parents
时间窗: The primary outcome will be measured at baseline (pre-intervention), and at 1 month and 3 months after the intervention, based on parent assessments.
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.
Severity of Body-Focused Repetitive Behaviors (BFRBs) in Children as Self-Reported by the Child
时间窗: Baseline, 1 month, 3 months
Children's self-reported experiences of BFRBs, including the frequency, duration, and distress, assessed through the custom-designed child version of the BFRBS questionnaire.
次要结局
- Children's Depression Inventory (CDI)(Baseline (pre-intervention), 1 month post-intervention, 3 months post-intervention)
- Screen for Child Anxiety Related Emotional Disorders (SCARED)(Baseline (pre-intervention), 1 month post-intervention, 3 months post-intervention)
- Piers-Harris Children's Self-Concept Scale (PHCSS)(Baseline (pre-intervention), 1 month post-intervention, 3 months post-intervention)
- Obsessive-Compulsive Inventory - Child Version (OCI-CV)(Baseline (pre-intervention), 1 month post-intervention, 3 months post-intervention)
- Short Form of the Egna Minnen Beträffande Uppfostran(s-EMBU)(Baseline (pre-intervention), 1 month post-intervention, 3 months post-intervention)
- Parenting Stress Index (PSI)(Baseline (pre-intervention), 1 month post-intervention, 3 months post-intervention)
- Conners Parent Rating Scale(Baseline (pre-intervention), 1 month post-intervention, 3 months post-intervention)
- Swanson, Nolan, and Pelham Teacher and Parent Rating Scale - Version IV (SNAP-IV)(Baseline (pre-intervention), 1 month post-intervention, 3 months post-intervention)
- The Family Assessment Device (FAD)(Baseline (pre-intervention), 1 month post-intervention, 3 months post-intervention)
研究者
Ding Qiang
Intermediate Psychotherapist , Department of Fudan University Psychiatry and Psychology，Children's Hospital of FuDan University
Children's Hospital of Fudan University