Back to resultsComparison of Effectiveness of Home Based Sensory Interventions Along With Standard Therapy Versus Standard Therapy Alone in Autistic Children With Sensory Processing Abnormalities
Primary Purpose
Autistic Children With Sensory Processing Abnormalities
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Sensory interventions
Sponsored by
About this trial
This is an interventional supportive care trial for Autistic Children With Sensory Processing Abnormalities focused on measuring Autistic spectrum disorder, Sensory processing abnormalities, Sensory interventions, occupational therapy
Eligibility Criteria
Inclusion Criteria:
- Children between the age group of 3-12years with autistic spectrum disorder as per DSM -V criteria along with CARS and those having sensory abnormalities as screened by short sensory profile 2 will be included in the study group
- Parents who agreed for home based sensory intervention therapy with strict adherence to same and to refrain from initiation of any new treatments including medications during study period
Exclusion Criteria:
- Children with epileptic syndromes with language regression(LKS)
- Children with features of ASD but having underlying structural(TS), neurometabolic or primary epilepsy as etiology
- Children with uncontrolled seizures (seizures in the last 06 months)
- Children whose parents do not give consent for the study
- Children for whom follow up would not be feasible
Sites / Locations
- Dr Hansashree P
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Children would receive both standard therapy and home based sensory interventions as described below, Standard therapy - children would receive measures like speech and language services, behavioral interventions and educational program regularly as and when decided by the primary care physician. They would be individualized to child specific needs . Home based sensory interventions - children would receive home based sensory interventions targeting visual and auditory system, tactile abnormalities, proprioceptive and vestibular abnormalities.These interventions would be carried out daily , at least 5 days a week, for a minimum duration of 1hour/day.
This group of children would receive only standard therapy as described below, Standard therapy - children would receive measures like speech and language services, behavioral interventions and educational program regularly as and when decided by the primary care physician. They would be individualized to child specific needs.
Outcomes
Primary Outcome Measures
1. Comparison of change in total score on 10 item Likert scale (as rated by parents)
Secondary Outcome Measures
1. Comparison of change in health related quality of life using PedsQL ( Pediatric quality of life inventory) questionnaire
2. Comparison of change in overall functional outcome using CGAS (Children's global assessment scale) questionnaire
Full Information
NCT ID
NCT02491645
First Posted
July 3, 2015
Last Updated
July 30, 2018
Sponsor
Postgraduate Institute of Medical Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT02491645
Brief Title
Comparison of Effectiveness of Home Based Sensory Interventions Along With Standard Therapy Versus Standard Therapy Alone in Autistic Children With Sensory Processing Abnormalities
Official Title
Comparison of Effectiveness of Home Based Sensory Interventions Along With Standard Therapy Versus Standard Therapy Alone in Autistic Children With Sensory Processing Abnormalities :An Open Label Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Around 69-95% of children with Autistic Spectrum Disorder are known to have sensory processing abnormalities .Tackling these problems would help in better quality of life, both for the parents and the children. Sensory integration therapy, an individualized clinic based therapy have been shown to have a positive effect on those children with sensory abnormalities. Hence the investigators are doing this study , to primarily look into the efficacy and feasibility of home based sensory interventions in autistic children with sensory processing abnormalities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Children With Sensory Processing Abnormalities
Keywords
Autistic spectrum disorder, Sensory processing abnormalities, Sensory interventions, occupational therapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Children would receive both standard therapy and home based sensory interventions as described below,
Standard therapy - children would receive measures like speech and language services, behavioral interventions and educational program regularly as and when decided by the primary care physician. They would be individualized to child specific needs .
Home based sensory interventions - children would receive home based sensory interventions targeting visual and auditory system, tactile abnormalities, proprioceptive and vestibular abnormalities.These interventions would be carried out daily , at least 5 days a week, for a minimum duration of 1hour/day.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
This group of children would receive only standard therapy as described below, Standard therapy - children would receive measures like speech and language services, behavioral interventions and educational program regularly as and when decided by the primary care physician. They would be individualized to child specific needs.
Intervention Type
Other
Intervention Name(s)
Sensory interventions
Intervention Description
Tactile stimulation: Brushing technique , handling materials of various textures, bear hug and rug , play dough and find in rice techniques to be done.
Proprioception technique : Joint compression , popping bubbles, lifting weights of different measures and scooter board push activities to be done.
Movement/vestibular techniques :Bear hug and rug , swinging or rocking motion, jumping or spinning to be done.
Visual stimulation : picture recognition, dot colouring , lighting balls and toys , familiarisation of emotions to be done.
Auditory stimulation : Sound familiarisation and music time will be done.
Primary Outcome Measure Information:
Title
1. Comparison of change in total score on 10 item Likert scale (as rated by parents)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
1. Comparison of change in health related quality of life using PedsQL ( Pediatric quality of life inventory) questionnaire
Time Frame
3 months
Title
2. Comparison of change in overall functional outcome using CGAS (Children's global assessment scale) questionnaire
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children between the age group of 3-12years with autistic spectrum disorder as per DSM -V criteria along with CARS and those having sensory abnormalities as screened by short sensory profile 2 will be included in the study group
Parents who agreed for home based sensory intervention therapy with strict adherence to same and to refrain from initiation of any new treatments including medications during study period
Exclusion Criteria:
Children with epileptic syndromes with language regression(LKS)
Children with features of ASD but having underlying structural(TS), neurometabolic or primary epilepsy as etiology
Children with uncontrolled seizures (seizures in the last 06 months)
Children whose parents do not give consent for the study
Children for whom follow up would not be feasible
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Hansashree Padmanabha, MD
Organizational Affiliation
Postgraduate Institute of Medical Education and Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr Hansashree P
City
Chandigarh
ZIP/Postal Code
160012
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Effectiveness of Home Based Sensory Interventions Along With Standard Therapy Versus Standard Therapy Alone in Autistic Children With Sensory Processing Abnormalities
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