Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006507
Status:
COMPLETED
Last Update Posted:
2007-01-17
First Post:
2000-11-04
Brief Title:
Occupational Therapy to Treat Children Who Over or Under React to Their Environment
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Occupational Therapy OT Outcomes Children With Sensory Modulation Disorders
Status:
COMPLETED
Status Verified Date:
2004-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 behavioralsocialemotional 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 needscharacteristics 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 childs 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 CBCLand 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
Measurements in the Impairment The Sensory Challenge protocol is a laboratory paradigm in which the childs 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 CBCLand 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2K08 HD01183-02 | None | None | None |