Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Occupational Therapy to Treat Children Who Over or Under React to Their Environment

This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00006507
First received: November 4, 2000
Last updated: January 16, 2007
Last verified: December 2004

November 4, 2000
January 16, 2007
March 1999
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00006507 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Occupational Therapy to Treat Children Who Over or Under React to Their Environment
Occupational Therapy (OT) Outcomes: Children With Sensory Modulation Disorders

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Sensory Disorders
Behavioral: Occupational Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
February 2002
Not Provided

Inclusion Criteria:

  • Diagnosis of Sensory Modulation Disorder (children must meet all three entrance criteria): a) Physiological criteria on Sensory Challenge Protocol; b) Functional criteria on Short Sensory Profile; c) Clinical Confirmation
  • IQ within normal limits (Bayley score greater than 85)

Exclusion Criteria:

  • Other Diagnoses (e.g., any DSM-IV or ICD-10 diagnosed condition except ADHD)
  • Previous occupational therapy
  • Serious complicating life events (e.g., adoption, death of parent, abuse or neglect, foster placement, drug or alcohol exposure)
  • Enrollment in Special Education or pull-out services
Both
54 Months to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006507
NICHD-0104, 2K08 HD01183-02
Not Provided
Not Provided
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
Principal Investigator: Lucy J. Miller, Ph.D. University of Colorado Health Sciences Center, Department of Pediatrics
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
December 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP