Acupressure and Acupuncture as an Intervention With Children With Autism II

This study has been completed.
Sponsor:
Collaborator:
Autism Speaks
Information provided by (Responsible Party):
Lana Warren, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00935701
First received: July 8, 2009
Last updated: April 1, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Autism Spectrum Disorder
Device: Acupressure and Acupuncture

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 11
Study Start Date: July 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00935701

Locations
United States, Maryland
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Autism Speaks
Investigators
Principal Investigator: Lana Warren, Ed.D. Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
  More Information

Publications:
Responsible Party: Lana Warren, FAC SRVP INSTRUCTOR, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00935701     History of Changes
Other Study ID Numbers: NA_00026158, 2949
Study First Received: July 8, 2009
Last Updated: April 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Autism Spectrum Disorder
Acupressure
Acupuncture

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on August 01, 2014