Trial Outcomes & Findings for Actigraphic Analysis of Treatment Response (NCT NCT00723580)

A six year old child with Autism Spectrum Disorder (pervasive developmental disorder) and Kabuki Syndrome anticipating a pharmacological intervention was evaluated for sleep and behavioral disturbances. She was invited to participate, her parents provided consent and the child acknowledged her assent.

The child had previously not responded to multiple medication trials, was stimulated by diphenylhydramine, over-sedated on clonidine and had mood destabilization when tried on mirtazapine. The child received no medication for the month preceding the initiation of the study.

Actigraphic Analysis of Treatment Response

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.

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.

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 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 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 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 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 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 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.