Investigating the Use of Acupressure and Acupuncture With Children With Autism II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Proportions of Children Completing Acupressure and Acupuncture Treatment.
研究概览
简要总结
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.
详细描述
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:
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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):
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Heart (arm)
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Spleen (leg)
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Stomach (leg)
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Kidney (leg)
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Bladder (leg)
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Liver (leg)
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Gallbladder (leg)
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Points: Focus on the following points throughout the study period:
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Ht 7 (arm)
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St 36 (leg)
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SP 6 (leg)
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Ki 3 (leg)
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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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Proportions of Children Completing Acupressure and Acupuncture Treatment.
时间窗: 2 months into Phase 1
次要结局
- Change in Conners' Rating Scales(Pre intervention (baseline), post intervention (8 weeks))
- Change in Children's Sleep Habits Questionnaire(Pre intervention (baseline), post intervention (8 weeks))
- Change in Parenting Stress Index(Pre intervention (baseline), post intervention (8 weeks))
研究者
Lana Warren
FAC SRVP INSTRUCTOR
Johns Hopkins University