Acupressure and Acupuncture as an Intervention With Children With Autism II
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

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.
    

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 will be introduced to acupuncture which will be continued throughout the rest
      of the study as tolerated. Sessions will be twice weekly and 30 minutes in length with the
      exception of the first session which will include an assessment and treatment session and be
      approximately an hour and a half. The total study period for Phase 1 is 8 weeks. The study
      acupuncturist has developed a proposed treatment protocol for children with ASD based upon
      the works cited above and his own clinical experience. This will be further developed and
      refined during the Phase I portion of this research. During the first session, which will
      include a TCM assessment and an initial treatment session, the acupuncturist will determine
      and initiate a treatment approach utilizing the 7 meridians and 4 points listed below based
      upon the assessment findings. Order of the treatment and direction of the strokes will be at
      the discretion of the acupuncturist. When treatment is introduced, this will be demonstrated,
      if deemed necessary by the practitioner, on a doll, the clinician or parent. Treatment
      involves points and pathways located on the child's arms, hands, feet and legs only. It will
      include:

        1. Meridians: Acupressure to the following meridians until acupuncture is introduced (
           these are also the strokes the parents will use at home throughout the duration of the
           treatment phase of the study):

             1. Heart (arm)

             2. Spleen (leg)

             3. Stomach (leg)

             4. Kidney (leg)

             5. Bladder (leg)

             6. Liver (leg)

             7. Gallbladder (leg)

        2. Points: Focus on the following points throughout the study period:

             1. Ht 7 (arm)

             2. St 36 (leg)

             3. SP 6 (leg)

             4. Ki 3 (leg)

        3. Additional Points: After the initial 4 weeks of acupressure reassess the child and
           begin, as tolerated, to introduce acupuncture treatment from the same acupuncture point
           list as identified above as well as the following extra points related specifically to
           the individual child's condition.

      Ht 8 Clears heat from the heart (hand) Liv 2 Clears heat from the body (foot) Liv 3 Calms
      mind and body and diffuses emotions (foot) St 41 Clears heat (foot) St 44 Clears heat from
      the body (foot) Sp 4 Tonifies spleen Qi (foot) GB 41 Clears heat (leg) GB 43 Hot phlegm
      (foot)

      From our experience with these children in Phase I, we will create a preliminary manual with
      guidelines for introducing acupressure to children with ASD, for transitioning to
      acupuncture, and for maintaining continued participation in the intervention. This manual
      will be reviewed by the Advisory Committee and occupational therapist for further comment as
      well as submitted to the IRB before proceeding to Phase 2.

      In Phase 2, we will conduct a preliminary clinical trial with 40 eligible children with ASD
      (and one parent for each child). The children will receive the manualized intervention twice
      weekly for 12 weeks for a total of up to 24 sessions. As above, sessions will be 30 minutes
      in length.

      Children who refuse or cannot tolerate acupressure by the fourth session will be discontinued
      from the study and another subject added. Parents will be trained in the acupressure
      techniques beginning with the first treatment session and will be asked to do this daily, at
      bedtime, and/or as requested by the child or deemed needed by the parent e.g. if child finds
      the study procedure calming, parent may initiate if child's behavior is escalating. Depending
      upon the child's response, this will take up to 15 minutes. Parents will be instructed not to
      perform acupressure if the child resists, but to continue to offer this each night. When
      parents are taught the techniques, they will be given an oral explanation with physical
      demonstration and written instructions with diagram. They will observe, do and teach and will
      be assessed for their proficiency at performing acupressure by the acupuncture practitioner.
      This will be done by observing the parent perform the acupressure strokes on the child and
      assessing pressure, accuracy, direction and speed. Parents will be given a structured diary
      which will include types of observations to make and minimum frequency.

      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. This will be determined by
      factors such as the child's receptivity and acceptance to touch during acupressure sessions,
      willingness to be treated, observation of relaxation during treatment, their reaction to
      being introduced to the needles, and report of positive behavioral changes by the child
      and/or parent. The child will be able to see and touch a needle as well as witness an
      insertion in the arm of the practitioner (or doll or parent) as deemed necessary by the
      practitioner. The child's reaction to this introduction will determine when the actual
      needling will begin. Needling will only begin with the child's verbal agreement. 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.

      Due to potential vacations, illnesses, and other events, the 24 treatments (16 for Phase 1)
      can occur over a 15 week period (10 for Phase 1), with no more than 2 sessions per week. Each
      child must participate in a minimum of 75% of the sessions (18 for Phase 2; 12 for Phase 1)
      to be included in the study. If a child misses sufficient sessions so that he/she is not able
      to meet the study criteria, treatment will be discontinued at that time.

      Children failing to meet this criteria due to unavoidable circumstances (e.g., family
      vacation, unrelated illness) will not be considered in analyses of study data. All other
      children failing to meet this criterion will be considered to have failed to tolerate
      acupuncture. One parent and the child's primary teacher will be asked to fill out
      questionnaires which will take parents approximately 70-120 minutes to complete and teachers
      approximately 45-70 minutes to complete on 3 different occasions (before, during and after
      the treatment). The parent will fill out five questionnaires that address the child's
      behavior, sleep, and parental level of stress. Questionnaires include: Behavior Assessment
      Scale for Children, Conners' Rating Scales, PDD Behavior Inventory, Parenting Stress
      Inventory and the Children's Sleep Inventory. The parent will also complete two additional
      questionnaires: Autism Parent Survey and Autism Child Survey. These questionnaires are
      designed to ascertain participants' response to treatment. One questionnaire is for the
      parent to complete, and the other is for the parent to complete together with the child, if
      possible. The teacher will fill out the Behavior Assessment Scale for Children, Conners'
      Rating Scales, and PDD Behavior Inventory,. The parent will sign a letter that is addressed
      to the teacher from the Primary Investigator that gives the teacher permission to complete
      the forms. The parent will also be asked to keep a structured diary (provided) noting any
      changes in behavior that they notice. Entries are to be made at a minimum weekly. The
      acupuncturist will remind parents to complete these entries each week.

      Phase 1 eligibility assessments will be conducted at Kennedy Krieger Institute Center for
      Autism and Related Disorders (CARD) and acupressure/acupuncture treatment sessions will be
      conducted at the CARD treatment rooms or at the acupuncturist's Catonsville offices.

      Phase 2 will occur in two different locations (Baltimore and Laurel/Silver Spring) at two
      different times to allow for a larger sample size and to be more convenient to families. At
      the conclusion of the study, parents will be kept informed of any publications that are the
      result of this study. Parents may also receive the acupuncturist's notes on the participant
      if requested.
    

Intervention name(s): Acupressure and Acupuncture
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autism Spectrum Disorder; Acupressure; Acupuncture