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

Sponsor

Postgraduate Institute of Medical Education and Research (Other)

Overall Status

Completed

CT.gov ID

NCT02491645

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Autistic Children With Sensory Processing Abnormalities	Other: Sensory interventions	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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 Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group 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 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.
No Intervention: Control group 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.

Arm

Intervention/Treatment

Experimental: Intervention group

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

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.

No Intervention: Control group

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.

Outcome Measures

Primary Outcome Measures

1. Comparison of change in total score on 10 item Likert scale (as rated by parents) [3 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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