Acupressure and Acupuncture as an Intervention With Children With Autism II
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 regulatory and behavioral functions. It is anticipated that: 1) children with ASD will tolerate acupressure and, when properly prepared, acupuncture; 2) parents and children will attend bi-weekly appointments over a 3 month period; 3) parents will find administered acupressure technique beneficial to their child and the parent/child relationship; 4) parents will report lower levels of stress regarding their parenting experience. In addition, we will learn information about specific child regulatory and behavior functions (including sleep and attention) from parent and teacher reports while the child receives acupressure and/or acupuncture. A small clinical trial will be conducted with 50 eligible children (3-10 years of age) with ASD (and one parent each) who will be enrolled into two groups: Phase 1 pre-pilot group of 10 children who will complete 8 weeks of treatment to help develop a treatment protocol; Phase 2 with 40 children treated for 12 weeks. Parents and teachers will complete pre-intern and post surveys, and children who do not tolerate acupressure/acupuncture will be counted as "treatment failures" for analyses.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Investigating the Use of Acupressure and Acupuncture With Children With Autism II|
- Proportions of children completing acupressure and acupuncture treatment. [ Time Frame: 2 months into Phase 1; 2 months into Phase 2 ] [ Designated as safety issue: No ]
- autistic symptoms [ Time Frame: 1 month and 2 months into Phase 1; 1 month and 2 months into Phase 2 ] [ Designated as safety issue: No ]
- children's sleep habits [ Time Frame: 1 month and 2 months into Phase 1; 1 month and 2 months into Phase 2 ] [ Designated as safety issue: No ]
- parental stress [ Time Frame: 1 month and 2 months into Phase 1; 1 month and 2 months into Phase 2 ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Experimental: Acupuncture and Acupressure
In Phase 1, 10 children with ASD will receive acupressure for four weeks. At week 5, they will be introduced to acupuncture which will be continued throughout the rest of the study as tolerated. In Phase 2, 40 children with ASD will receive acupressure twice weekly for 12 weeks. Parents will be trained in the acupressure techniques and will be asked to do this daily, at bedtime, and/or as requested by the child or deemed needed by the parent. Children will begin to be assessed for their ability to participate in acupuncture treatment between weeks 5 and 7 at the discretion of the acupuncturist. By week 7, all children will have been introduced to acupuncture/needling. If needling is still refused at this time, acupressure will continue for the remainder of the study.
Device: Acupressure and Acupuncture
Acupressure involves the stimulation of specific acupoints by firm pressure, while acupuncture involves the insertion of very fine needles (the size of a strand of hair). The needles may be quickly inserted and removed or left in up to 5 minutes at a time.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00935701
|United States, Maryland|
|Kennedy Krieger Institute|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Lana Warren, Ed.D.||Hugo W. Moser Research Institute at Kennedy Krieger, Inc.|