NCT00352352

Brief Summary

This is a study of the efficacy of acupuncture in children with autism.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2006

Completed
Last Updated

July 14, 2006

Status Verified

July 1, 1999

First QC Date

July 13, 2006

Last Update Submit

July 13, 2006

Conditions

AutismAutistic Disorder

Keywords

Traditional Chinese Medicine (TCM)Alternative Medicine (AM)Tongue Acupuncture (TAC)Autism Spectrum Disorder (ASD)AutismChildren

Outcome Measures

Primary Outcomes (4)

  • Ritvo-Freeman Real Life Scale (RFRLS) was conducted on both groups before (Week 0) and after (Week 8) acupuncture.

  • Functional Independence Measure for children (WeeFIM) consists of 18 questions concerning on the Functional Independence Measure for children, which was conducted on both groups before (Week 0) and after (Week 8) acupuncture.

  • Parental Stress Index (PSI) consists of child domain, parent domain and a total domain, which was conducted on both groups before (Week 0) and after (Week 8) acupuncture.

  • Clinical Global Impression Scale (CGIS) is a measure in a Likert scale of 0 - 7, which was conducted on both groups before (Week 0) and after (Week 8) acupuncture.

Interventions

Tongue Acupuncture (Procedure)PROCEDURE

Eligibility Criteria

Age3 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • The diagnosis of ASD or autism was made according to the criteria of the 4th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and Autism Diagnostic Interview-Revised (ADI-R).
  • The diagnosis of autism was made if it satisfied a score greater than 30 in the Childhood Autism Rating Scale (CARS).

You may not qualify if:

  • Children with associated neurological disorders such as Tuberous Sclerosis, Fragile X Syndrome and epilepsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duchess of Kent of Children Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Autistic DisorderAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Wong Virginia

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 13, 2006

First Posted

July 14, 2006

Last Updated

July 14, 2006

Record last verified: 1999-07

Locations

HK(1)