Actigraphic Analysis of Treatment Response in a Six Year Old Girl With Kabuki Syndrome
Overview
- Phase
- Not Applicable
- Intervention
- risperidone
- Conditions
- Sleep Disorders, Circadian Rhythm
- Sponsor
- Child Psychopharmacology Institute
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Actigraphic Measurement of Treatment Conditions
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The study examines and illustrates the utility of utilizing actigraphic measurements to assess treatment response.
Detailed Description
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. Actigraphic measurements were made utilizing a watch-like actigraphic device with an 11 day baseline actigraphic measurement period and continued measurements that included the initiation of a Once-Daily, Bedtime (q.h.s.) pharmacological intervention for 6 days, followed by a planned adjustment to Twice a Day (b.i.d.) dosing that was measured for an additional 4 days. Repeated actigraphic studies were subsequently conducted after 22 months of risperidone treatment and were collected along with the repeated observational and psychometric data. This case study explores activity and sleep characteristics related to behavioral characteristics and treatment response and the utility of single subject repeated actigraphic, psychometric and observational measurements and monitoring of treatment response.
Investigators
Bill J. Duke, M.A., Ph.D., ABMPP
Director
Child Psychopharmacology Institute
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of Kabuki Syndrome
- •Medication Naive
- •Single subject preparing to receive pharmacological intervention
Exclusion Criteria
- •Inability to wear actigraphy device
Arms & Interventions
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.
Intervention: risperidone
Outcomes
Primary Outcomes
Actigraphic Measurement of Treatment Conditions
Time Frame: 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.
Secondary Outcomes
- 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)