Use of Acupuncture In Children With Autistic Spectrum Disorder

NCT00346736 | Completed Phase 3

• 1 other identifier: UW 04-096 T/418
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Autism is a behaviorally defined, lifelong disorder of the brain, affecting at least 1-2 per 1000 children. There is an increasing trend of autism worldwide. However, to date, there is still no cure for this devastating childhood disease. Autism is characterized by deficit in language, social communication and repetitive behavior. It is estimated that the annual cost of care for autism is $13 billion in USA alone. Children with autism usually have associated behavioral problems such as aggressiveness, stereotypes, hyperactivity, emotional lability, and short attention span. The National Institute of Child Health \& Human Development and National Institute of Deafness \& Communication Disorders have jointly founded the Collaborative Programs of Excellence in Autism. One of the long-term NIH goals is to develop or refine interim treatment strategy and to develop effective biological, behavioral or alternative treatment strategy for autism. There is a dire need for early identification and treatment of children with autism. Acupuncture has been practised in China for 2 millennia. The legal status of acupuncture as a treatment technique was approved by Food \& Drugs Administration in USA (1997). The therapeutic effect of acupuncture is based on stimulation at specific acupoints resulting in both local and distant effect via improving signal or modulation of electromagnetic energy. There had lack of studies of acupuncture in autism. We hope that we can study the efficacy of acupuncture in autism using clinical measurement. We hope to identify the role of acupuncture as an adjunctive treatment for autism.

Conditions

Autistic Disorder; Autism

Keywords

Alternative medicine; Traditional Chinese medicine; Acupuncture; Autistic Spectrum Disorder; Autism; Children

Outcome Measures

Primary Outcomes (4)

• Aberrant Behavioral Checklist (ABC) will be completed by parents and teachers at Week 0, once during Week 6 to Week 7, and once during Week 14 to Week 15.

• Ritvo-Freeman Real LIfe Scale (RFRLS) will be completed by parents and teachers at Week 0, once during Week 6 to Week 7, and once during Week 14 to Week 15.

• Functional Independence Measure for Children (WeeFIM) will be conducted by trained Research Assistant at Week 0, once during Week 6 to Week 7, and once during Week 14 to Week 15.

• Pediatric Evaluation Disability Inventory (PEDI) will be completed by parents and teachers at Week 0, once during Week 6 to Week 7, and once during Week 14 to Week 15.

Secondary Outcomes (4)

• Leiter International Performance Scale-Revised will be conducted on patient by trained Research Assistant at Week 0, once during Week 6 to Week 7, and once during Week 14 to Week 15.

• Reynell Language Developmental Scale will be conducted on patient by trained Research Assistant at Week 0, once during Week 6 to Week 7, and once during Week 14 to Week 15.

• Symbolic Play Test will be conducted on patient by trained Research Assistant at Week 0, once during Week 6 to Week 7, and once during Week 14 to Week 15.

• Clinical Global Impression Scale (CGIS) will be self administered by parent and by trained Research Assistant at Week 0, once during Week 6 to Week 7, and once during Week 14 to Week 15.

Interventions

Acupuncture (Procedure) PROCEDURE

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• fulfilled the criteria for autism of the 4th edition of the Diagnostic and Statistical Manual of Mental Disorders on the basis of observation of the child, and
• fulfilled the criteria for autism of a structured diagnostic interview of a parent using Autism Diagnostic Interview-Revised, and
• had a score on the Childhood Autism Rating Scale of 30 or more, and
• Clinical Global Impression Scale of moderately ill or markedly ill or severely ill

You may not qualify if:

• children on chronic anti-epileptics or neuroleptics

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

TWGHs Tung Wah Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Wong Virginia

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 29, 2006
• First Posted: June 30, 2006
• Study Start: May 1, 2005
• Primary Completion: June 1, 2006
• Study Completion: March 1, 2007
• Last Updated: September 3, 2008

Record last verified: 2008-09

Locations

HK (1)