Mindfulness Intervention for Psychological and Family Dynamics in Children with Body-Focused Repetitive Behaviors (MIND-BFRB)

Fudan University

Status: Active, not recruiting

Conditions: Psychosocial Education; Mindfulness Skills

Treatments: Behavioral: Mindfulness Training Program; Behavioral: Psychosocial Education Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06777212

CHFD-2025-01-BFRB

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

200 participants in 2 patient groups

Mindfulness intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness Training Program

Psychosocial Education Control Group

Experimental group

Description:

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.

Treatment:

Behavioral: Psychosocial Education Program