Actigraphic Analysis of Treatment Response in a Six Year Old Girl With Kabuki Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Actigraphic Measurement of Treatment Conditions
研究概览
简要总结
The study examines and illustrates the utility of utilizing actigraphic measurements to assess treatment response.
详细描述
Actigraphic measurements will be recorded every 30 seconds and will be recorded for an 11 day baseline period, followed by a 10 day period of the initial pharmacological interventions. The non-invasive nature of watch-like actigraphy devices is particularly attractive for use in pediatric populations. Meaningful treatment response measurements are obtained when actigraphic data is combined with psychometric and observational repeated measurements. Subsequent to the initial data collection the parent consented and the child assented to extend the study and continue measurements.
The case study included baseline and repeated psychological, observational and actigraphic measurements that were initiated prior to treatment with risperidone and repeated throughout the treatment process with the final data collected in July 2010.
The Personality Inventory for Children (PIC) is an objective multidimensional measurement of affect, behavior, ability and family function. The PIC was administered prior to treatment with risperidone and repeated after 22 months of treatment. The PIC serves as both an actuarial pre-treatment diagnostic tool as well as a post-treatment repeated measurement indicating treatment associated change.
A primary observer (mother) was trained to report symptom percentages present since previous observations utilizing the operationally defined and observer defined items of the systematic observation scale throughout the treatment process.
Actigraphic measurements provide a basis by which to measure sleep and sleep onset latency as well as periods of mobility and immobility. When programmed to record activity every thirty seconds, thousands of measurements are quickly captured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 10 Years(Child)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Kabuki Syndrome
- •Medication Naive
- •Single subject preparing to receive pharmacological intervention
排除标准
- •Inability to wear actigraphy device
研究组 & 干预措施
Sleep and Activity by Treatment Condition
Actigraphic measurements were obtained by attaching an actigraphic watch device to the child's non-dominant wrist. The measurements will include three separate three week periods beginning with a baseline period and the period in which the child's pharmacological treatment was initiated. Two additional three week actigraphic measurement periods will occur at 22 months post-baseline period and at 23 months post-baseline period. The resulting five treatment conditions were: 1. Baseline no medication 2. Risperidone .25 mg at bedtime (q.h.s.) x 7 days 3. Risperidone .25 mg twice daily (b.i.d.) 4. Risperidone .25 mg three times a day (t.i.d.) and 5. Risperidone .5 mg three times a day (t.i.d.). Sleep and activity will be evaluated by treatment conditions.
干预措施: risperidone (Drug)
结局指标
主要结局
Actigraphic Measurement of Treatment Conditions
时间窗: May 12- July 14, 2010
The child's impulsivity and inability to sleep represented a significant symptom and risk factor. Impulsivity and sleep will be actigraphically assessed by treatment conditions.
次要结局
- The Personality Inventory for Children: Adjustment Scale(May-7-2008 to July -14-2010)
- Systematic Observation Scale: Percentage of Hyperactivity Observed(May-7-2008 to July -14-2010)
- The Personality Inventory for Children: Somatic-Physiological Scale(May-7-2008 to July -14-2010)
- Systematic Observation Scale Item: Percentage of Impulsivity Observed(May-7-2008 to July -14-2010)
- Systematic Observation Scale: Percentage of Irritability Observed(May-7-2008 to July -14-2010)
- The Personality Inventory for Children: Achievement Scale(May-7-2008 to July -14-2010)
- The Personality Inventory for Children: Social Skills Scale(May-7-2008 to July -14-2010)
- The Personality Inventory for Children: Family Relations Scale(May-7-2008 to July -14-2010)
- Systematic Observation Scale: Percentage of Distractibility Observed(May-7-2008 to July -14-2010)
- The Personality Inventory for Children: Delinquency Scale(May 7, 2008-July 14,2010)
- The Personality Inventory for Children: Withdrawal Scale(May-7-2008 to July -14-2010)
研究者
Bill J. Duke, M.A., Ph.D., ABMPP
Director
Child Psychopharmacology Institute
