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

NCT ID: NCT06777212

Last Updated: 2025-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Mindfulness Skills Psychosocial Education

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Mindfulness Training Program

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Psychosocial Education Program

Intervention Type 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.

Interventions

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Mindfulness Training 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.

Intervention Type BEHAVIORAL

Psychosocial Education Program

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

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Exclusion Criteria

(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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Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Ding Qiang

Intermediate Psychotherapist , Department of Fudan University Psychiatry and Psychology,Children's Hospital of FuDan University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qiang Ding

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Fudan University

Locations

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Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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CHFD-2025-01-BFRB

Identifier Type: -

Identifier Source: org_study_id

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