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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04167839
Other study ID # TWU protocol# 19711
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 6, 2017
Est. completion date February 15, 2018

Study information

Verified date November 2019
Source Pingale, Vidya, OTR
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Sensory diets are one of the interventions occupational therapists use in school-based settings to manage manifestations of sensory processing disorder. However, very few studies have investigated the effectiveness of sensory diets, and the results of these studies were mixed. Past studies also had methodological limitations. Therefore, this study investigated the effect of sensory diets on children's sensory processing skills, psychosocial skills, and engagement in classroom activities. This study used a single-subject ABCA design. Five children between the ages of five and eleven years participated in the study. The study consisted of an initial baseline phase A1, the control intervention phase B, sensory diets intervention phase C, and the second baseline phase A2. Each phase lasted for seven days. The PI videotaped each participant for fifteen minutes each school day during all phases to collect the data. The participants were videotaped during classroom group activities. Visual analysis of the data showed that sensory diets had a positive effect on participants' sensory processing, psychosocial skills, and classroom engagement.


Recruitment information / eligibility

Status Completed
Enrollment 5
Est. completion date February 15, 2018
Est. primary completion date February 15, 2018
Accepts healthy volunteers No
Gender Male
Age group 4 Years to 11 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Sensory diet
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.

Locations

Country Name City State
United States Vidya Pingale Cliffside Park New Jersey

Sponsors (5)

Lead Sponsor Collaborator
Pingale, Vidya, OTR Catherine Candler, PhD, OTR, Karen Dunlap, EdD, Noralyn Pickens, PhD, OT, Tina S. Fletcher, EdD, MFA, OTR

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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

Watling R, Hauer S. Effectiveness of Ayres Sensory Integration® 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary 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.
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