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

NCT02491645 | Completed

• 1 other identifier: PGIMER-HS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Autistic Children With Sensory Processing Abnormalities

Keywords

Autistic spectrum disorder; Sensory processing abnormalities; Sensory interventions; occupational therapy

Outcome Measures

Primary Outcomes (1)

• 1. Comparison of change in total score on 10 item Likert scale (as rated by parents)

  3 months

Secondary Outcomes (2)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Sensory interventions OTHER

1. Tactile stimulation: Brushing technique , handling materials of various textures, bear hug and rug , play dough and find in rice techniques to be done. 2. Proprioception technique : Joint compression , popping bubbles, lifting weights of different measures and scooter board push activities to be done. 3. Movement/vestibular techniques :Bear hug and rug , swinging or rocking motion, jumping or spinning to be done. 4. Visual stimulation : picture recognition, dot colouring , lighting balls and toys , familiarisation of emotions to be done. 5. Auditory stimulation : Sound familiarisation and music time will be done.

Intervention group

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Dr Hansashree P

Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Dr Hansashree Padmanabha, MD

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior resident , pursuing DM Pediatric neurology

Study Record Dates

• First Submitted: July 3, 2015
• First Posted: July 8, 2015
• Study Start: February 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 1, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)