Comparison of Effectiveness of Home Based Sensory Interventions Along With Standard Therapy Versus Standard Therapy Alone in Autistic Children With Sensory Processing Abnormalities

Study Overview
=================
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.

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

Conditions
-----------------
Autistic Children With Sensory Processing Abnormalities

Intervention / Treatment
-----------------
* Other: Sensory interventions


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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. | Other: Sensory interventions<br>* 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.<br>|
| No Intervention: Control group<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Comparison of change in total score on 10 item Likert scale (as rated by parents) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Comparison of change in health related quality of life using PedsQL ( Pediatric quality of life inventory) questionnaire |  | 3 months | 
| 2. Comparison of change in overall functional outcome using CGAS (Children's global assessment scale) questionnaire |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autistic spectrum disorder, Sensory processing abnormalities, Sensory interventions, occupational therapy