Mindfulness Intervention for Psychological and Family Dynamics in Children with Body-Focused Repetitive Behaviors

NCT06777212 | Active Not Recruiting

• 1 other identifier: CHFD-2025-01-BFRB
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Mindfulness Skills; Psychosocial Education

Keywords

Mindfulness Intervention; Body-Focused Repetitive Behaviors; Psychological Intervention; Nail-Biting; Skin-Picking; Hair-Pulling

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, 1 month, 3 months

Secondary Outcomes (9)

• 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

Study Arms (2)

Mindfulness intervention Group

EXPERIMENTAL

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

Psychosocial Education Control Group

EXPERIMENTAL

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

Interventions

Mindfulness Training Program BEHAVIORAL

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.

Mindfulness intervention Group

Psychosocial Education Program BEHAVIORAL

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.

Psychosocial Education Control Group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• （3）Written informed consent provided by the parent or legal guardian, and child assent provided by the participant.

You may not qualify if:

• （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.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

MeSH Terms

Conditions

Nail Biting; Excoriation Disorder; Trichotillomania

Condition Hierarchy (Ancestors)

Habits; Behavior; Self-Injurious Behavior; Behavioral Symptoms; Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders

Study Officials

• Qiang Ding

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Intermediate Psychotherapist , Department of Fudan University Psychiatry and Psychology，Children's Hospital of FuDan University

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 15, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Start Date: 6 months after the publication of the primary study results. End Date: 5 years after the publication of the primary study results.
• Access Criteria: Individual participant data and supporting information, including the study protocol, statistical analysis plan (SAP), informed consent form (ICF), clinical study report (CSR), and analytic code, will be made available to qualified researchers upon request. Access will be granted for academic and non-commercial purposes only. Researchers must submit a formal request to dingqiang@fudan.edu.cn, detailing their research objectives, study design, and ethical approval from an institutional review board (IRB) or ethics committee. Once approved, the requested data will be provided through secure channels, ensuring compliance with data privacy regulations and participant confidentiality. Access will be available for a period of 5 years following the publication of the primary study results.

Locations

CN (1)