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View Clinical Trial (Medical Research Study)
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Acupressure and Acupuncture as an Intervention With Children With Autism II - NCT00935701-21205 (Clinical Trial 301219)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy301219.aspx
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| City: |
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Baltimore |
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State:
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MD |
| Zip Code: |
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21205 |
| Conditions: |
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Autism Spectrum Disorder |
| Purpose: |
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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
45 eligible children (6-10 years of age) with ASD (and one parent each) who will be enrolled
into two groups: Phase 1 pre-pilot group of 5 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.
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| Study summary: |
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This study will be conducted in two phases. In Phase 1, we will have 5 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) 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 teacher will fill out the first three
questionnaires listed previously. 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 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 given a copy of their child's data and will be
kept informed of any publications that are the result of this study. |
| Criteria: |
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Inclusion Criteria:
- In addition to qualifying by age and IQ, 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. Parents
will be given a 1-2 page summary of the testing results within 1 month of
administration.
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. |
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| Study is available at: |
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Kennedy Krieger Institute
Baltimore, MD 21205
United States
Primary Contact:
Lana Warren, Ed.D.
Email: WarrenL@kennedykrieger.org
Phone: 443-923-9312
Secondary Contact:
Lana Warren, Ed. D.
Email: WarrenL@kennedykrieger.org
Phone: 443-923-9312 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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