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Sensory Processing DisorderNCT04167839

Effects of Sensory Diets on Children's Sensory Processing Skills, Psychosocial Skills, and Classroom Engagement

A study testing Sensory diet in people with Sensory Processing Disorder and Special Education, run by Pingale, Vidya, OTR at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 4 to 11 years, men only
What is being tested?
Sensory diet
How many people
5 participants
Where
1 siteUnited States
Study dates
6 Sep 2017to 15 Feb 2018
Phase
Interventional
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 4 to 11 years
  • Men only
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Vidya Pingale

    Cliffside Park, New Jersey, 07010

Other trials in United States

About this study

Official title: Effects of Sensory Diets on a Child's Sensory Processing Skills, Psychosocial Skills, and Classroom Engagement

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.

Read the detailed 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.

Being tested
Sensory diet
Medical subject headings
Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sensory dietOther

    Also called Non-therapeutic activities or activities without a therapeutic goal (Placebo)

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: The data was collected for 28 days; each day for each phase for 15 minutes.

  2. 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.

    Measured: The data was collected for 28 days; each day for each phase for 15 minutes.

  3. 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.

    Measured: The data was collected for 28 days; each day for each phase for 15 minutes.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2019
  2. Study start6 Sep 2017
  3. Primary completion15 Feb 2018
  4. Study completion15 Feb 2018

Resources

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04167839
Sponsor's protocol ID
TWU protocol# 19711
Status last verified
Nov 2019
First submitted
11 Nov 2019
Last updated
19 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 18556898

  • 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.

    PubMed 24477447

  • 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.

    PubMed 26356655

  • 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.

    PubMed 21161577

Questions about this trial

What is this clinical trial studying?

A study testing Sensory diet in people with Sensory Processing Disorder and Special Education, run by Pingale, Vidya, OTR 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 3 inclusion and 3 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 19 Nov 2019. 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.

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.

What does the primary outcome measure?

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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04167839, which also lists 5 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 19 Nov 2019.

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