Sensory DisordersPhase 2NCT00006507
Occupational Therapy to Treat Children Who Over or Under React to Their Environment
A Phase 2 study testing Occupational Therapy in people with Sensory Disorders, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 54 months to 11 years
- Conditions the study is for
- Sensory Disorders
- What is being tested?
- Occupational Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Mar 1999to Feb 2002
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 54 months to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Health Sciences Center
Littleton, Colorado, 80120
About this study
Official title: 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.
Read the 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.
- Conditions
- Sensory Disorders
- Being tested
- Occupational Therapy
- Keywords
- Sensory integration, Occupational therapy, Sensory Modulation Dysfunction (SMD)
- Medical subject headings
- Sensation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational TherapyBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2000 (estimated)
- Study startMar 1999
- Study completionFeb 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Sensory DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Lucy J. Miller, Ph.D., Principal investigator, University of Colorado Health Sciences Center, Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006507
- Sponsor's protocol ID
- NICHD-0104
- Other IDs
- 2K08 HD01183-02
- Status last verified
- Dec 2004
- First submitted
- 4 Nov 2000
- Last updated
- 17 Jan 2007
- Results posted
- No
Publications
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.
PubMed 10686625Miller, 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.
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.
PubMed 9544354Miller 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.
PubMed 10208160McIntosh 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.
PubMed 10503919McIntosh, 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational Therapy (OT) Outcomes: Children With Sensory Modulation Disorders
- ClinicalTrials.gov ID
- NCT00006507
- Acronym / sponsor ID
- NICHD-0104
- Conditions
- Sensory Disorders
- Keywords
- Sensory integration, Occupational therapy, Sensory Modulation Dysfunction (SMD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Mar 1999
- Study completion
- Feb 2002
- First posted
- 6 Nov 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 54 months to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occupational Therapy | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2007.
- Background: PubMed 10686625Cohn 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.
- BackgroundMiller, 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: PubMed 9544354Ermer 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.
- Background: PubMed 10208160Miller 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.
- Background: PubMed 10503919McIntosh 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.
- BackgroundMcIntosh, 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.
- Click here for more information about the National Institute of Child Health and Human Development.Link provided by the sponsor.
Related trials for Sensory Disorders
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucy J. Miller, Ph.D. principal investigator
University of Colorado Health Sciences Center, Department of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Occupational Therapy in people with Sensory Disorders, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006507, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2007.