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Actigraphic Analysis of Treatment Response

Primary Purpose

Sleep Disorders, Circadian Rhythm, Insomnia, Psychomotor Agitation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
risperidone
Sponsored by
Child Psychopharmacology Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Sleep Disorders, Circadian Rhythm focused on measuring Kabuki Syndrome, Actigraphy, Treatment Response Measurement

Eligibility Criteria

2 Years - 10 Years (Child)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of Kabuki Syndrome
  • Medication Naive
  • Single subject preparing to receive pharmacological intervention

Exclusion Criteria:

  • Inability to wear actigraphy device

Sites / Locations

  • Child Psychopharmacology Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sleep and Activity by Treatment Condition

Arm Description

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.

Outcomes

Primary Outcome Measures

Actigraphic Measurement of Treatment Conditions
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 Outcome Measures

Systematic Observation Scale Item: Percentage of Impulsivity Observed
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
Systematic Observation Scale: Percentage of Distractibility Observed
Systematic Observation Scale: Percentage of Hyperactivity Observed
The Personality Inventory for Children: Adjustment Scale
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
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
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
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
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
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
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.

Full Information

First Posted
July 24, 2008
Last Updated
July 28, 2015
Sponsor
Child Psychopharmacology Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00723580
Brief Title
Actigraphic Analysis of Treatment Response
Official Title
Actigraphic Analysis of Treatment Response in a Six Year Old Girl With Kabuki Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Child Psychopharmacology Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorders, Circadian Rhythm, Insomnia, Psychomotor Agitation
Keywords
Kabuki Syndrome, Actigraphy, Treatment Response Measurement

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleep and Activity by Treatment Condition
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
risperidone
Other Intervention Name(s)
Actigraphic measurements
Intervention Description
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.).
Primary Outcome Measure Information:
Title
Actigraphic Measurement of Treatment Conditions
Description
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.
Time Frame
May 12- July 14, 2010
Secondary Outcome Measure Information:
Title
Systematic Observation Scale Item: Percentage of Impulsivity Observed
Description
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.
Time Frame
May-7-2008 to July -14-2010
Title
Systematic Observation Scale: Percentage of Irritability Observed
Time Frame
May-7-2008 to July -14-2010
Title
Systematic Observation Scale: Percentage of Distractibility Observed
Time Frame
May-7-2008 to July -14-2010
Title
Systematic Observation Scale: Percentage of Hyperactivity Observed
Time Frame
May-7-2008 to July -14-2010
Title
The Personality Inventory for Children: Adjustment Scale
Description
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.
Time Frame
May-7-2008 to July -14-2010
Title
The Personality Inventory for Children: Achievement Scale
Description
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.
Time Frame
May-7-2008 to July -14-2010
Title
The Personality Inventory for Children: Somatic-Physiological Scale
Description
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.
Time Frame
May-7-2008 to July -14-2010
Title
The Personality Inventory for Children: Delinquency Scale
Description
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.
Time Frame
May 7, 2008-July 14,2010
Title
The Personality Inventory for Children: Withdrawal Scale
Description
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
Time Frame
May-7-2008 to July -14-2010
Title
The Personality Inventory for Children: Social Skills Scale
Description
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.
Time Frame
May-7-2008 to July -14-2010
Title
The Personality Inventory for Children: Family Relations Scale
Description
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.
Time Frame
May-7-2008 to July -14-2010

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Kabuki Syndrome Medication Naive Single subject preparing to receive pharmacological intervention Exclusion Criteria: Inability to wear actigraphy device
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bill J Duke, M.A., Ph.D.
Organizational Affiliation
Child Psychopharmacology Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child Psychopharmacology Institute
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States

12. IPD Sharing Statement

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