Acupressure and Acupuncture as an Intervention With Children With Autism II

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00935701
Recruitment Status : Completed
First Posted : July 9, 2009
Results First Posted : September 26, 2014
Last Update Posted : April 18, 2017
Autism Speaks
Information provided by (Responsible Party):
Lana Warren, Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Device: Acupressure and Acupuncture Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigating the Use of Acupressure and Acupuncture With Children With Autism II
Study Start Date : July 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Proportions of Children Completing Acupressure and Acupuncture Treatment. [ Time Frame: 2 months into Phase 1 ]

Secondary Outcome Measures :
  1. Change in Conners' Rating Scales [ Time Frame: Pre intervention (baseline), post intervention (8 weeks) ]
    The Conners' Rating Scales Revised (CRS-R) is used to assess attention deficit hyperactivity disorder (ADHD) as well as other related behavioral concerns. The CRS-R is made up of 14 scales. Analysis was done on 6 of these scales: Conners' Global Index Restless-Impulsive, Conners' Global Index Emotional Lability, Conners' Global Index Total, DSM-IV Inattentive, DSM-IV Hyperactive-Impulsive, and DSM-IV Total. Raw scores are converted to T-scores, based on age and gender of the child. A high T-score indicates a greater number and/or frequency of reported concerns. Pre T-scores were subtracted from post T-scores to calculate the change in T-score.

  2. Change in Children's Sleep Habits Questionnaire [ Time Frame: Pre intervention (baseline), post intervention (8 weeks) ]
    The Children's Sleep Habits Questionnaire (CSHQ) assesses sleep problems common in school-age children and is comprised of eight subscales. Each item receives a score from 1 (meaning the problem occurs rarely) to 3 (meaning the problem usually occurs); therefore, a higher score is the worse outcome. Scale ranges are as follows: Bedtime Resistance: 6 to 18, Sleep Onset Delay: 1 to 3, Sleep Duration: 3 to 9, Sleep Anxiety: 4 to 12, Night Wakings: 3 to 9, Parasomnias: 7 to 21, Disordered Breathing: 3 to 9, Daytime Sleepiness: 8 to 24, and Total Disturbance (items from all scales): 33 to 99. Subscale scores from pre intervention were subtracted from post subscale scores in order to get the change in scores.

  3. Change in Parenting Stress Index [ Time Frame: Pre intervention (baseline), post intervention (8 weeks) ]
    The Parenting Stress Index (PSI) was designed for parents of children ages 1:6 to 12:5 and identifies stressors in the parent-child relationship. Specifically, the PSI measures child's characteristics on six subscales, which are summed get a total score in the child domain (47 to 235). The PSI also has seven subscales that measure parent characteristics, and are summed to get a total score in the parent domain (54 to 270). The totals from the parent and child domains are summed for a total stress score (101 to 505). Higher scores indicate a higher level of stress. Pre scores were subtracted from post scores in order to get the change in scores.

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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00935701

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

Responsible Party: Lana Warren, FAC SRVP INSTRUCTOR, Johns Hopkins University Identifier: NCT00935701     History of Changes
Other Study ID Numbers: NA_00026158
First Posted: July 9, 2009    Key Record Dates
Results First Posted: September 26, 2014
Last Update Posted: April 18, 2017
Last Verified: March 2017

Keywords provided by Lana Warren, Johns Hopkins University:
Autism Spectrum Disorder

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders