Actigraphic Analysis of Treatment Response

Overview

The study examines and illustrates the utility of utilizing actigraphic measurements to assess treatment response.

Full Title of Study: “Actigraphic Analysis of Treatment Response in a Six Year Old Girl With Kabuki Syndrome”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2010

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.

Interventions

  • Drug: risperidone
    • Five treatment conditions: 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.).

Arms, Groups and Cohorts

  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Systematic Observation Scale Item: Percentage of Impulsivity Observed
    • Time Frame: May-7-2008 to July -14-2010
    • The Systematic Observation Scale utilizes single-subject repeated measurements. Symptoms and issues of interest are defined and a variety of frequency and sampling methods can be applied. The Systematic Observation Scale was designed so Primary Observers (parents, guardians, self observers or others) can make pre-treatment and subsequent observations to track, document and evaluate symptom variation over the course of an illness. The measurement utilized is the percentage of time the symptom is observed by the primary observer since the previous observation.
  • Systematic Observation Scale: Percentage of Irritability Observed
    • Time Frame: May-7-2008 to July -14-2010
  • Systematic Observation Scale: Percentage of Distractibility Observed
    • Time Frame: May-7-2008 to July -14-2010
  • Systematic Observation Scale: Percentage of Hyperactivity Observed
    • Time Frame: May-7-2008 to July -14-2010
  • The Personality Inventory for Children: Adjustment Scale
    • Time Frame: May-7-2008 to July -14-2010
    • This scale measures general personality adjustment reflecting a dimension associated with highly adaptive to maladaptive adjustment. The Personality Inventory for Children (PIC) is an age and gender referenced 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 and developmentally associated change.
  • The Personality Inventory for Children: Achievement Scale
    • Time Frame: May-7-2008 to July -14-2010
    • The factors that underlie this scale are academic ability, poor achievement, impulsivity, limited concentration and over or under-assertiveness with peers. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.
  • The Personality Inventory for Children: Somatic-Physiological Scale
    • Time Frame: May-7-2008 to July -14-2010
    • The factors that underlie this scale are fatigue, aches and pains, insomnia, somatic response to stress and malingering. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.
  • The Personality Inventory for Children: Delinquency Scale
    • Time Frame: May 7, 2008-July 14,2010
    • The factors that underlie this scale are poor frustration tolerance, irritability, sadness, lack of interest, hostility,limited social participation and resistance to authority. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.
  • The Personality Inventory for Children: Withdrawal Scale
    • Time Frame: May-7-2008 to July -14-2010
    • The factors that underlie this scale are physical isolation, Shyness, isolation from peers, emotional distance and isolated intellectual interests. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function
  • The Personality Inventory for Children: Social Skills Scale
    • Time Frame: May-7-2008 to July -14-2010
    • The factors that underlie this scale are social success, social rejection, adults as only social contacts, and the ability to lead and follow. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.
  • The Personality Inventory for Children: Family Relations Scale
    • Time Frame: May-7-2008 to July -14-2010
    • The factors that underlie this scale are family stability, inter-parent communication, presence of love and happiness in the home and appropriateness of discipline. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosis of Kabuki Syndrome – Medication Naive – Single subject preparing to receive pharmacological intervention Exclusion Criteria:

  • Inability to wear actigraphy device

Gender Eligibility: Female

Minimum Age: 2 Years

Maximum Age: 10 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Child Psychopharmacology Institute
  • Provider of Information About this Clinical Study
    • Principal Investigator: Bill J. Duke, M.A., Ph.D., ABMPP, Director – Child Psychopharmacology Institute
  • Overall Official(s)
    • Bill J Duke, M.A., Ph.D., Principal Investigator, Child Psychopharmacology Institute

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