Acupressure and Acupuncture as an Intervention With Children With Autism II
|First Received Date ICMJE||July 8, 2009|
|Last Updated Date||April 1, 2013|
|Start Date ICMJE||July 2009|
|Primary Completion Date||February 2011 (final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||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 ]|
|Original Primary Outcome Measures ICMJE
||Proportions of children completing acupressure and acupuncture treatment. [ Time Frame: After phase 2 is completed ] [ Designated as safety issue: No ]|
|Change History||Complete list of historical versions of study NCT00935701 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
||Parenting stress, autistic symptoms, children's sleep habits [ Time Frame: After phase 2 is completed ] [ Designated as safety issue: No ]|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Acupressure and Acupuncture as an Intervention With Children With Autism II|
|Official Title ICMJE||Investigating the Use of Acupressure and Acupuncture 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.
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:
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.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||Autism Spectrum Disorder|
|Intervention ICMJE||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.
|Study Arm (s)||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.
Intervention: Device: Acupressure and Acupuncture
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||February 2011|
|Primary Completion Date||February 2011 (final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||3 Years to 10 Years|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00935701|
|Other Study ID Numbers ICMJE||NA_00026158, 2949|
|Has Data Monitoring Committee||No|
|Responsible Party||Lana Warren, Johns Hopkins University|
|Study Sponsor ICMJE||Johns Hopkins University|
|Collaborators ICMJE||Autism Speaks|
|Information Provided By||Johns Hopkins University|
|Verification Date||April 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP