Insomnia Clinical Trial
Official title:
Actigraphic Analysis of Treatment Response in a Six Year Old Girl With Kabuki Syndrome
The study examines and illustrates the utility of utilizing actigraphic measurements to assess treatment response.
Status | Completed |
Enrollment | 1 |
Est. completion date | August 2010 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 2 Years to 10 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of Kabuki Syndrome - Medication Naive - Single subject preparing to receive pharmacological intervention Exclusion Criteria: - Inability to wear actigraphy device |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
United States | Child Psychopharmacology Institute | Fargo | North Dakota |
Lead Sponsor | Collaborator |
---|---|
Child Psychopharmacology Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | May 12- July 14, 2010 | No |
Secondary | 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. | May-7-2008 to July -14-2010 | No |
Secondary | Systematic Observation Scale: Percentage of Irritability Observed | May-7-2008 to July -14-2010 | No | |
Secondary | Systematic Observation Scale: Percentage of Distractibility Observed | May-7-2008 to July -14-2010 | No | |
Secondary | Systematic Observation Scale: Percentage of Hyperactivity Observed | May-7-2008 to July -14-2010 | No | |
Secondary | 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. | May-7-2008 to July -14-2010 | No |
Secondary | 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. | May-7-2008 to July -14-2010 | No |
Secondary | 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. | May-7-2008 to July -14-2010 | No |
Secondary | 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. | May 7, 2008-July 14,2010 | No |
Secondary | 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 | May-7-2008 to July -14-2010 | No |
Secondary | 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. | May-7-2008 to July -14-2010 | No |
Secondary | 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. | May-7-2008 to July -14-2010 | No |
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