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

Autistic Children With Sensory Processing Abnormalities Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02491645
• Other study ID #: PGIMER-HS
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: December 2017

Study information

• Verified date: July 2018
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Autistic Children With Sensory Processing Abnormalities
• Autistic Disorder
• Congenital Abnormalities

Intervention

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.

Locations

Country	Name	City	State
India	Dr Hansashree P	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Comparison of change in total score on 10 item Likert scale (as rated by parents)		3 months
Secondary	1. Comparison of change in health related quality of life using PedsQL ( Pediatric quality of life inventory) questionnaire		3 months
Secondary	2. Comparison of change in overall functional outcome using CGAS (Children's global assessment scale) questionnaire		3 months