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

Not Applicable

Completed

• Conditions: Autistic Children With Sensory Processing Abnormalities
• Interventions: Other: Sensory interventions

• Registration Number: NCT02491645
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-07-03
• Study First Submitted QC: 2015-07-07
• Study First Posted: 2015-07-08
• Primary Completion: 2017-06
• Study Completion: 2017-12
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-30
• Last Update Posted: 2018-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Sensory interventions	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dr Hansashree P; 🇮🇳 Chandigarh, India