- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04167839
Effects of Sensory Diets on Children's Sensory Processing Skills, Psychosocial Skills, and Classroom Engagement
Effects of Sensory Diets on a Child's Sensory Processing Skills, Psychosocial Skills, and Classroom Engagement
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Jersey
-
Cliffside Park, New Jersey, United States, 07010
- Vidya Pingale
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children between the ages of four and eleven years and attending pre-kindergarten through fourth grade
- Children eligible for occupational therapy services under the special education eligibility criteria or under section 504 of the Rehabilitation Act of 1973-subpart D. This subpart of section 504 ensures children with disabilities who do not meet the eligibility criteria for special education services and are placed in general education classrooms receive the necessary support and related services (such as occupational therapy) to fully participate in general education classrooms.
- Children who scored in the Definite Difference range (+ 2 SD) or Probable Difference (+ 1 SD) ranges on two or more sections or quadrants on the Sensory Profile-2, Teacher Questionnaire (SP-2 Teacher Questionnaire; Dunn, 2015) were included in this study
Exclusion Criteria:
Children with medical concerns, such as cardiac conditions, posing risk to participate in resistive (strenuous) gross motor activities or children who used mobility devices were excluded from the study as these conditions may have hindered their participation in sensory diet activities.
- Children who were on medications, such as stimulants, anti-anxiety or anti-convulsive medications were excluded from the study as these medications may influence the clinical representation of SPD and interfere with the study outcomes.
- Children who were currently receiving sensory diets or received sensory diets six months prior to the beginning of the study were excluded from the study to control for confounding.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in frequency of a target behaviors related to psycho-social behaviors
Time Frame: The data was collected for 28 days; each day for each phase for 15 minutes.
|
This outcome measure was individualized for each participant and detected change in frequency of psycho-social behaviors.
The target behavior was identified and individualized based on the analysis of the intake data using classroom observations, Sensory profile school companion 2nd edition results, Behavior assessment system for children 3rd edition results, and teacher interview.
|
The data was collected for 28 days; each day for each phase for 15 minutes.
|
|
Change in duration of a target behavior related to off-task behaviors.
Time Frame: The data was collected for 28 days; each day for each phase for 15 minutes.
|
This outcome measure individualized for each participant and detected change in duration of off-task behaviors.
The target behavior was identified and individualized based on the analysis of the intake data using classroom observations, Sensory profile school companion 2nd edition results, Behavior assessment system for children 3rd edition results, and teacher interview.
|
The data was collected for 28 days; each day for each phase for 15 minutes.
|
|
Change in duration of a target behavior related to sensory seeking behaviors.
Time Frame: The data was collected for 28 days; each day for each phase for 15 minutes.
|
This outcome measure individualized for each participant and detected change in duration of sensory seeking behaviors.
The target behavior was identified and individualized based on the analysis of the intake data using classroom observations, Sensory profile school companion 2nd edition results, Behavior assessment system for children 3rd edition results, and teacher interview.
|
The data was collected for 28 days; each day for each phase for 15 minutes.
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Fazlioglu Y, Baran G. A sensory integration therapy program on sensory problems for children with autism. Percept Mot Skills. 2008 Apr;106(2):415-22. doi: 10.2466/pms.106.2.415-422.
- Lopez, M., & Swinth, Y. (2008). A group proprioceptive program's effect on physical aggression in children. Journal of Occupational Therapy, Schools & Early Intervention, 1(2), 147-166. doi: 10.1080/19411240802313044
- Case-Smith J, Weaver LL, Fristad MA. A systematic review of sensory processing interventions for children with autism spectrum disorders. Autism. 2015 Feb;19(2):133-48. doi: 10.1177/1362361313517762. Epub 2014 Jan 29.
- Watling R, Hauer S. Effectiveness of Ayres Sensory Integration(R) and Sensory-Based Interventions for People With Autism Spectrum Disorder: A Systematic Review. Am J Occup Ther. 2015 Sep-Oct;69(5):6905180030p1-12. doi: 10.5014/ajot.2015.018051.
- Devlin S, Healy O, Leader G, Hughes BM. Comparison of behavioral intervention and sensory-integration therapy in the treatment of challenging behavior. J Autism Dev Disord. 2011 Oct;41(10):1303-20. doi: 10.1007/s10803-010-1149-x.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TWU protocol# 19711
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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