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

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

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.

Study Overview

• Status: Completed
• Conditions: Autistic Children With Sensory Processing Abnormalities
• Intervention / Treatment: Other: Sensory interventions

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • Dr Hansashree P

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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
2. 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:

1. Children with epileptic syndromes with language regression(LKS)
2. Children with features of ASD but having underlying structural(TS), neurometabolic or primary epilepsy as etiology
3. Children with uncontrolled seizures (seizures in the last 06 months)
4. Children whose parents do not give consent for the study
5. Children for whom follow up would not be feasible

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research
• Investigators: Principal Investigator: Dr Hansashree Padmanabha, MD, Postgraduate Institute of Medical Education and Research

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (ACTUAL): June 1, 2017
• Study Completion (ACTUAL): December 1, 2017

Study Registration Dates

• First Submitted: July 3, 2015
• First Submitted That Met QC Criteria: July 7, 2015
• First Posted (ESTIMATE): July 8, 2015

Study Record Updates

• Last Update Posted (ACTUAL): August 1, 2018
• Last Update Submitted That Met QC Criteria: July 30, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: occupational therapy; Autistic spectrum disorder; Sensory processing abnormalities; Sensory interventions
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Congenital Abnormalities; Autistic Disorder
• Other Study ID Numbers: PGIMER-HS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No