NCT04167839

Brief Summary

This study investigated the effects of a sensory diet intervention program on five children with a sensory processing disorder. The effect was investigated on children's sensory processing skills, psychosocial skills, and classroom engagement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

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

September 6, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
Last Updated

November 19, 2019

Status Verified

November 1, 2019

Enrollment Period

5 months

First QC Date

November 11, 2019

Last Update Submit

November 16, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in frequency of a target behaviors related to psycho-social behaviors

    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.

    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.

    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.

Interventions

Sensory diets are one of the interventions occupational therapists use in school-based settings to manage manifestations of sensory processing disorder. Sensory diets are composed of exercises and multisensory activities that are tailored for children and provide them sensorimotor experiences to facilitate their participation in daily activities.

Also known as: Non-therapeutic activities or activities without a therapeutic goal (Placebo)

Eligibility Criteria

Age4 Years - 11 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \- 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vidya Pingale

Cliffside Park, New Jersey, 07010, United States

Location

Related Publications (5)

  • 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.

    PMID: 18556898BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 24477447BACKGROUND
  • 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.

    PMID: 26356655BACKGROUND
  • 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.

MeSH Terms

Conditions

Autistic Disorder

Interventions

Exercise

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Second observers were masked from participants' evaluation data and treatment phase
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Student

Study Record Dates

First Submitted

November 11, 2019

First Posted

November 19, 2019

Study Start

September 6, 2017

Primary Completion

February 15, 2018

Study Completion

February 15, 2018

Last Updated

November 19, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations