Clinical trial NCT06777212: Mindfulness Intervention for Psychological and Family Dynamics in Children with Body-Focused Repetitive Behaviors
Official title: Mindfulness Intervention and Its Impact on Psychological and Family Dynamics in Children with Body-Focused Repetitive Behaviors.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mindfulness Skills
Psychosocial Education
Keywords: Mindfulness Intervention
Body-Focused Repetitive Behaviors
Psychological Intervention
Nail-Biting
Skin-Picking
Hair-Pulling
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 200
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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.

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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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Primary outcomes:
measure: Severity of Body-Focused Repetitive Behaviors (BFRBs) in Children as Reported by Parents
timeFrame: The primary outcome will be measured at baseline (pre-intervention), and at 1 month and 3 months after the intervention, based on parent assessments.
measure: Severity of Body-Focused Repetitive Behaviors (BFRBs) in Children as Self-Reported by the Child
timeFrame: Baseline, 1 month, 3 months
Secondary outcomes:
measure: Children's Depression Inventory (CDI)
timeFrame: Baseline (pre-intervention), 1 month post-intervention, 3 months post-intervention
measure: Screen for Child Anxiety Related Emotional Disorders (SCARED)
timeFrame: Baseline (pre-intervention), 1 month post-intervention, 3 months post-intervention
measure: Piers-Harris Children's Self-Concept Scale (PHCSS)
timeFrame: Baseline (pre-intervention), 1 month post-intervention, 3 months post-intervention
measure: Obsessive-Compulsive Inventory - Child Version (OCI-CV)
timeFrame: Baseline (pre-intervention), 1 month post-intervention, 3 months post-intervention
measure: Short Form of the Egna Minnen Beträffande Uppfostran(s-EMBU)
timeFrame: Baseline (pre-intervention), 1 month post-intervention, 3 months post-intervention
measure: Parenting Stress Index (PSI)
timeFrame: Baseline (pre-intervention), 1 month post-intervention, 3 months post-intervention
measure: Conners Parent Rating Scale
timeFrame: Baseline (pre-intervention), 1 month post-intervention, 3 months post-intervention
measure: Swanson, Nolan, and Pelham Teacher and Parent Rating Scale - Version IV (SNAP-IV)
timeFrame: Baseline (pre-intervention), 1 month post-intervention, 3 months post-intervention
measure: The Family Assessment Device (FAD)
timeFrame: Baseline (pre-intervention), 1 month post-intervention, 3 months post-intervention
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Qiang Ding
role: PRINCIPAL_INVESTIGATOR
References: