Evaluation of the Effectiveness of Bian-Stone Therapy in Children With Autism Spectrum Disorder

NCT06998459 | Completed

• 1 other identifier: REC 111-13
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Autism spectrum disorder (ASD) is a pervasive developmental disorder of brain abnormalities. It presents with difficulties of communication and social interaction, and restrictive interests and restrictive behaviors. The CDC suggested that the popularity of ASD people is 1.5% in the US, and the male to female ratio is 4.5 to 1. In Taiwan, the popularity is around 1%, with the number increasing in recent years. The exact etiology of ASD has remained unknown. Currently, the treatments include behavioral therapies, medication and alternative therapies. However, there is no specific way to cure the core symptoms of ASD. This study plans to apply behavioral therapies and traditional Chinese medical Bian-stone therapies on ASD children and compare the results between ASD children with only behavioral therapies. We will record theAutism Behavior Checklist-Taiwan Version, Development Screening Chart for Children Aged 0-6 Years, and Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) before and after the treatments, and meanwhile using the Ryodoraku Measurement (良導絡) to measure the meridian energy. This study aims to evaluate the effectiveness of traditional Chinese medical Bian-stone therapies in ASD children. In addition, we hope to investigate the relationship between ASD symptoms and twelve meridians and assess the patterns in Chinese medicine. Hopefully this study will help strengthen the clinical evidence in TCM treatments for ASD children and improve the efficacy of this disease.

Conditions

Evaluation of Bian Stone Therapy for Autism Spectrum Disorder

Keywords

Bian-Stone therapy

Outcome Measures

Primary Outcomes (3)

• Autism Behavior Checklist-Taiwan Version

  This checklist includes 47 items across five categories: sensory, relating, body and object use, language, and social and self-help skills. The raw score is based on the number of questions answered "yes." This score is then compared with appropriate norms to determine the individual's position relative to the norms. Pre-test, mid-test at 3 months, and post-test at 6 months. Development Screening Chart for Children Aged 0-6 Years This scale measures development across five categories: communication and language development, social and personality development, gross motor skills, fine motor skills, and perceptual and cognitive development. It includes 19 age groups, from birth to 72 months, and organizes developmental abilities in order.

  Pre-test, mid-test at 3 months, and post-test at 6 months.

• Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)

  This tool assesses adaptive behavior across four domains: communication, daily living skills, socialization, and motor skills. It provides standard scores for each domain and an overall composite score, with lower scores indicating higher levels of impairment. Age-equivalent scores for each domain were calculated by averaging the subdomain scores, based on previous research methodologies.

  Pre-test, mid-test at 3 months, and post-test at 6 months.

• Development Screening Chart for Children Aged 0-6 Years

  This scale measures development across five categories: communication and language development, social and personality development, gross motor skills, fine motor skills, and perceptual and cognitive development. It includes 19 age groups, from birth to 72 months, and organizes developmental abilities in order.

  Pre-test, mid-test at 3 months, and post-test at 6 months.

Secondary Outcomes (1)

• Meridian Energy Analysis Device

  Pre-test, mid-test at 3 months, and post-test at 6 months.

Study Arms (2)

Bian-Stone therapy

EXPERIMENTAL

Once a week, each session lasting 30 minutes, for a duration of six months.

Other: Bian-Stone therapy

control group

PLACEBO COMPARATOR

Maintain the original treatment approach

Other: Maintain the original treatment approach

Interventions

Bian-Stone therapy OTHER

Once a week, each session lasting 30 minutes, for a duration of six months.

Bian-Stone therapy

Maintain the original treatment approach OTHER

Maintain the original treatment approach

control group

Eligibility Criteria

• Age: 18 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosed with Autism Spectrum Disorder (ASD) based on DSM-5 diagnostic criteria, and additionally screened using the T-STAT assessment tool, with severity categorized as mild or moderate.
• Patients aged between 1.5 and under 6 years, regardless of gender. 3.A Full-Scale IQ of 70 or above as measured by the Wechsler Intelligence Scale for Children (WISC).
• No prior experience with Bianshi therapy. 5.Consent obtained from the patient or their guardian to provide relevant clinical data for use in this study.

You may not qualify if:

• Presence of other comorbid conditions, such as Tuberous Sclerosis, Fragile X Syndrome, Timothy Syndrome, male Rett Syndrome (with MECP2 gene mutation), and other chromosomal abnormalities (e.g., Angelman syndrome, Prader-Willi syndrome, Phelan-McDermid syndrome, and other related syndromes).
• Use of dietary supplements or health products.

Sponsors & Collaborators

• Taichung Tzu Chi Hospital: lead

Study Sites (1)

Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Taichung, 427, Taiwan

Location

Study Officials

• Shu-Yu Yang

  Taichung Tzu Chi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Pediatrics, Division of Traditional Chinese Medicine

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: May 31, 2025
• Study Start: April 28, 2025
• Primary Completion: April 28, 2025
• Study Completion: April 28, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)