Acupressure and Acupuncture as an Intervention With Children With Autism II

NCT00935701 | Completed Results

• 2 other identifiers: NA_000261582949
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; Acupressure; Acupuncture

Outcome Measures

Primary Outcomes (1)

• Proportions of Children Completing Acupressure and Acupuncture Treatment.

  2 months into Phase 1

Secondary Outcomes (3)

• Change in Conners' Rating Scales

  Pre intervention (baseline), post intervention (8 weeks)

• Change in Children's Sleep Habits Questionnaire

  Pre intervention (baseline), post intervention (8 weeks)

• Change in Parenting Stress Index

  Pre intervention (baseline), post intervention (8 weeks)

Study Arms (1)

Acupuncture and Acupressure

EXPERIMENTAL

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

Interventions

Acupressure and Acupuncture DEVICE

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.

Acupuncture and Acupressure

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Autism Speaks: collaborator

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

Related Publications (7)

• Hanson E, Kalish LA, Bunce E, Curtis C, McDaniel S, Ware J, Petry J. Use of complementary and alternative medicine among children diagnosed with autism spectrum disorder. J Autism Dev Disord. 2007 Apr;37(4):628-36. doi: 10.1007/s10803-006-0192-0.

  PMID: 16977497 BACKGROUND

• Green VA, Pituch KA, Itchon J, Choi A, O'Reilly M, Sigafoos J. Internet survey of treatments used by parents of children with autism. Res Dev Disabil. 2006 Jan-Feb;27(1):70-84. doi: 10.1016/j.ridd.2004.12.002.

  PMID: 15919178 BACKGROUND

• Flaws, B. (1997) A Handbook of TCM Pediatrics. Michigan: Blue Poppy Press.

  BACKGROUND

• Clark, E., & Zhou, Z. (2005). Autism in China: From acupuncture to applied behavior analysis. Psychology in the Schools, 42(3), 285-295.

  BACKGROUND

• Cullen L, Barlow J. 'Kiss, cuddle, squeeze': the experiences and meaning of touch among parents of children with autism attending a Touch Therapy Programme. J Child Health Care. 2002 Sep;6(3):171-81. doi: 10.1177/136749350200600303.

  PMID: 12224834 BACKGROUND

• Cullen-Powell LA, Barlow JH, Cushway D. Exploring a massage intervention for parents and their children with autism: the implications for bonding and attachment. J Child Health Care. 2005 Dec;9(4):245-55. doi: 10.1177/1367493505056479.

  PMID: 16275663 BACKGROUND

• Escalona A, Field T, Singer-Strunck R, Cullen C, Hartshorn K. Brief report: improvements in the behavior of children with autism following massage therapy. J Autism Dev Disord. 2001 Oct;31(5):513-6. doi: 10.1023/a:1012273110194.

  PMID: 11794416 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Acupressure; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Limitations and Caveats

There were no limitations to this study.

Results Point of Contact

• Title: Lana Warren
• Organization: Kennedy Krieger Institute

WarrenL@kennedykrieger.org

4439239312

Study Officials

• Lana Warren, Ed.D.

  Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: FAC SRVP INSTRUCTOR

Study Record Dates

• First Submitted: July 8, 2009
• First Posted: July 9, 2009
• Study Start: July 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: April 18, 2017
• Results First Posted: September 26, 2014

Record last verified: 2017-03

Locations

US (1)