NCT00006507

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 1999

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1999

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2000

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2000

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2002

Completed
Last Updated

January 17, 2007

Status Verified

December 1, 2004

First QC Date

November 4, 2000

Last Update Submit

January 16, 2007

Conditions

Sensory Disorders

Keywords

Sensory integrationOccupational therapySensory Modulation Dysfunction (SMD)

Interventions

Occupational TherapyBEHAVIORAL

Eligibility Criteria

Age54 Months - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Health Sciences Center

Littleton, Colorado, 80120, United States

Location

Related Publications (6)

  • Cohn E, Miller LJ, Tickle-Degnen L. Parental hopes for therapy outcomes: children with sensory modulation disorders. Am J Occup Ther. 2000 Jan-Feb;54(1):36-43. doi: 10.5014/ajot.54.1.36.

    PMID: 10686625BACKGROUND

  • Miller, L. J., & Lane, S. J. (2000). Toward a consensus in terminology in Sensory Integration theory and practice: Part 1: Taxonomy of neurophysiological processes. Sensory Integration Special Interest Section, 23(1), 1-4.

    BACKGROUND

  • Ermer J, Dunn W. The sensory profile: a discriminant analysis of children with and without disabilities. Am J Occup Ther. 1998 Apr;52(4):283-90. doi: 10.5014/ajot.52.4.283.

    PMID: 9544354BACKGROUND

  • Miller LJ, McIntosh DN, McGrath J, Shyu V, Lampe M, Taylor AK, Tassone F, Neitzel K, Stackhouse T, Hagerman RJ. Electrodermal responses to sensory stimuli in individuals with fragile X syndrome: a preliminary report. Am J Med Genet. 1999 Apr 2;83(4):268-79.

    PMID: 10208160BACKGROUND

  • McIntosh DN, Miller LJ, Shyu V, Hagerman RJ. Sensory-modulation disruption, electrodermal responses, and functional behaviors. Dev Med Child Neurol. 1999 Sep;41(9):608-15. doi: 10.1017/s0012162299001267.

    PMID: 10503919BACKGROUND

  • McIntosh, D.N., Miller, L.J., & Shyu, V. (1999). Overview of the Short Sensory Profile (SSP). In W. Dunn (Ed.), The sensory profile: Examiner's manual (pp. 59-83). San Antonio, TX: The Psychological Corporation.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Sensation Disorders

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Lucy J. Miller, Ph.D.

    University of Colorado Health Sciences Center, Department of Pediatrics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

November 4, 2000

First Posted

November 6, 2000

Study Start

March 1, 1999

Study Completion

February 1, 2002

Last Updated

January 17, 2007

Record last verified: 2004-12

Locations

US(1)