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OpenTrials
Completed

NCT Number: NCT02491645

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

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.

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Key information

Conditions

Autistic Children With Sensory Processing Abnormalities Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr Hansashree P

Chandigarh, 160012, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sensory interventions

Other
  • 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.

Primary outcomes

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

    Time frame: 3 months

Secondary outcomes

  1. 1. Comparison of change in health related quality of life using PedsQL ( Pediatric quality of life inventory) questionnaire

    Time frame: 3 months

  2. 2. Comparison of change in overall functional outcome using CGAS (Children's global assessment scale) questionnaire

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 8, 2015
Registry last updated
Aug 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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