Occupational Therapy to Treat Children Who Over or Under React to Their Environment
Condition: Sensory Disorders
MeSH terms: Sensation Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Children with Sensory Modulation Dysfunction (SMD) either over- or under-react to stimuli in
      their environment. This can cause significant problems with daily activities and may lead to
      anxiety, poor attention, low self-esteem, and further complications in motor, cognitive,
      social and emotional development. Diagnosis of SMD is based on physiological responses to
      specific stimuli, measures of behavioral/social/emotional symptoms, and studies of the
      resulting functional limitation and disability. Treatments involve direct biomedical and
      behavioral intervention to improve sensory processing, as well as adjustments to the home,
      school and community environment. This study will compare the effect of occupational therapy
      vs. alternative therapy on the reactivity and function of children who have SMD.
    

Detailed description: 
      This single masked, crossover trial will randomize children with Sensory Modulation
      Dysfunction (SMD) to either Occupational Therapy (OT), alternative treatment (Activity
      Protocol), or delayed treatment (initially the control group). Children are assigned to one
      of the three treatment groups using a random numbers table with block randomization.
      Assignments are made by the research assistant, who is masked to assessments, parent
      priorities, and family needs/characteristics. Using block procedures, the first child is
      randomly assigned to treatment group A, B, or C. The next child entered to the study at that
      age, gender and socioeconomic status (parents' education) is randomly assigned to one of the
      two remaining groups. The third child meeting age, gender and SES criteria is automatically
      assigned to the remaining group. This procedure reduces seasonal confounds and chance
      variation between group characteristics. The order of treatment by group is: GROUP A (OT -
      1st 10 weeks; Activity - 2nd 10 weeks); GROUP B (Activity - 1st 10 weeks; OT - 2nd 10 wks);
      GROUP C (Wait list - 1st 10 weeks; OT - 2nd 10 wks; Activity - 3rd 10 wks). Inclusion in the
      study is based on standardized assessments of physiological reactivity after a "Sensory
      Challenge Protocol", a technique developed by this research group and published in several
      medical journals. Standardized measurements of physiologic, behavioral and emotional status,
      are administered before treatment, after each treatment condition, and after all treatments
      are completed by investigators masked to treatment; and including the following:

      Measurements in the Impairment: The Sensory Challenge protocol is a laboratory paradigm in
      which the child's physiologic reactivity after sensation is tested using electrodermal
      reactivity and vagal tone indices to assess sympathetic and parasympathetic systems.
      Measurements of functional limitations include aggression, withdrawal, impulsivity,
      hyperactivity, inattention, and sensitivity to tactile, movement, taste, smell, auditory and
      visual stimuli. These are measured in the areas: (1) attention (subscales of the
      parent-report Child Behavior Checklist [CBCL],and Leiter International Performance
      Scale-Revised; the Continuous Performance Task, the StopTask and the Go-No Go Task); (2)
      emotion (the CBCL); (3) sensation (the Short Sensory Profile; the Leiter-R; the
      Multidimensional Anxiety Scale for Children; the Stop Task; the Go-No-Go Task; the Auditory
      Continuous Performance Test). Measures of the Disability Dimension include the Vineland
      Scales of Adaptive Behavior, the Goal Attainment Scale, and play and dinner-time paradigms.
      Finally, measures in Societal Limitations Dimension include a parent semi-structured
      interview and the Visual Analogue Scale.

      Occupational therapy is a targeted protocol involving functional and sensory-integration
      activities, supported by family-based activities at home.
    

Intervention name(s): Occupational Therapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Sensory integration; Occupational therapy; Sensory Modulation Dysfunction (SMD)