Status:
COMPLETED
Acupressure and Acupuncture as an Intervention With Children With Autism II
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Autism Speaks
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
3-10 years
Phase:
NA
Brief Summary
The purpose of this study is to see if children with autism spectrum disorder (ASD) will tolerate an acupressure and acupuncture intervention twice weekly over a 3 month period of time that targets re...
Detailed Description
This study will be conducted in two phases. In Phase 1, we will have 10 children with ASD (and 1 parent each for each child). The children will receive acupressure for four weeks. At week five, they w...
Eligibility Criteria
Inclusion
- In addition to qualifying by age and IQ (IQ of at least 50), children will meet two of three of the following criteria for ASD (PDD-NOS, Autism or Asperger Syndrome): (1) Autism Diagnostic Observation Schedule-Generic, (ADOS-G) algorithm criteria for ASD or Autism, (Lord, Rutter, DiLavore, \& Risi, 2001) (2) Autism Diagnostic Interview-Revised, (ADI-R) algorithm criteria (Lord, Rutter, \& Le Couteur, 2003) meeting criteria for autism for the social or communication domain by being within 2 points of the algorithm cut-off for autism on the other, or coming within 1 point of the cut-off for autism on both and (3) have clinical judgment of autism, PDD-NOS or Asperger Syndrome by an autism expert. All of the ADOS-G testing sessions will be videotaped with inter-rater reliability being conducted on 20% of children tested. These videotapes will be destroyed following determination of study eligibility for those found not eligible. For those who are eligible, the videotapes will be destroyed after eligibility is determined or, for the 20% used for determining inter-rater reliability, the videotapes will be destroyed following this analysis. Parents will be asked not to start any new intervention or modification of current intervention during the study period unless deemed absolutely necessary. If such a change has to be made, the parents are requested to inform the Principal Investigator and either participation will be discontinued (without consideration as a treatment failure) or data subsequent to that point will be excluded from analyses.
Exclusion
- Children who have had any significant medication or treatment change within the past four weeks prior to the beginning of the study, children who are in foster care, children with a bleeding disorder, children who are not proficient in English, children who do not have normal hearing with or without aides, and children failing to meet inclusion criteria will not be eligible for the study. If a child has a significant change in his entrance treatment program (e.g.; significant change in medication, school placement) during the study, the PI in consultation with Advisory Committee members, Dr. Rebecca Landa and Dr. Andrew Zimmerman, both autism research experts, will determine if the child is appropriate to remain in the study. Parents who are not proficient in English will not be included in the study.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00935701
Start Date
July 1 2009
End Date
February 1 2011
Last Update
April 18 2017
Active Locations (1)
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1
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205