Autistic Children With Sensory Processing AbnormalitiesNCT02491645
Comparison of Effectiveness of Home Based Sensory Interventions Along With Standard Therapy Versus Standard Therapy Alone in Autistic Children With Sensory Processing Abnormalities
A study testing Sensory interventions in people with Autistic Children With Sensory Processing Abnormalities, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Autistic Children With Sensory Processing Abnormalities
- What is being tested?
- Sensory interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Sensory interventions
- Keywords
- Autistic spectrum disorder, Sensory processing abnormalities, Sensory interventions, occupational therapy
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory interventionsOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Comparison of change in total score on 10 item Likert scale (as rated by parents)
Measured: 3 months
Secondary outcomes (2)
1. Comparison of change in health related quality of life using PedsQL ( Pediatric quality of life inventory) questionnaire
Measured: 3 months
2. Comparison of change in overall functional outcome using CGAS (Children's global assessment scale) questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic Children With Sensory Processing AbnormalitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Hansashree P, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Dr Hansashree Padmanabha, MD, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491645
- Sponsor's protocol ID
- PGIMER-HS
- Status last verified
- Jul 2018
- First submitted
- 3 Jul 2015
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02491645
- Acronym / sponsor ID
- PGIMER-HS
- Keywords
- Autistic spectrum disorder, Sensory processing abnormalities, Sensory interventions, occupational therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 8 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Sensory interventionsChildren 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. |
| 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. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory interventions1. 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. | Other | Intervention group |
Primary outcome
1. Comparison of change in total score on 10 item Likert scale (as rated by parents)
Time frame: 3 months
2 secondary outcomes
1. Comparison of change in health related quality of life using PedsQL ( Pediatric quality of life inventory) questionnaire
Time frame: 3 months
2. Comparison of change in overall functional outcome using CGAS (Children's global assessment scale) questionnaire
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Autistic Children With Sensory Processing Abnormalities
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Neurodevelopmental Disorders, Neurodevelopmental Disorders (NDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Hansashree Padmanabha, MD principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory interventions in people with Autistic Children With Sensory Processing Abnormalities, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Comparison of change in total score on 10 item Likert scale (as rated by parents) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2018.