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CTRI Number  CTRI/2022/11/047680 [Registered on: 25/11/2022] Trial Registered Prospectively
Last Modified On: 04/11/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Mobile-App in Hindi and English to Identify Children aged 3-11 years with Autism and ADHD 
Scientific Title of Study   Development of a Bi-lingual Mobile-App based Neuro-Cognitive Screening Tool for Early Identification of Children aged 3-11 years with Autism and ASD co-morbid with ADHD 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sujata Satapathy 
Designation  Additional Professor (Clinical Psychology)  
Affiliation  Department of Psychiatry, AIIMS, New Delhi 
Address  Department of Psychiatry AIIMS Delhi

South West
DELHI
110029
India 
Phone    
Fax    
Email  sujatasatapathy2022@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sujata Satapathy 
Designation  Additional Professor (Clinical Psychology)  
Affiliation  Department of Psychiatry, AIIMS, New Delhi 
Address  Department of Psychiatry AIIMS Delhi


DELHI
110029
India 
Phone    
Fax    
Email  sujatasatapathy2022@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sujata Satapathy 
Designation  Additional Professor (Clinical Psychology)  
Affiliation  Department of Psychiatry, AIIMS, New Delhi 
Address  Department of Psychiatry AIIMS Delhi


DELHI
110029
India 
Phone    
Fax    
Email  sujatasatapathy2022@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, Ansari Nagar East, New Delhi-110029 
 
Primary Sponsor  
Name  ICMR 
Address  New Delhi 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sujata Satapathy  AIIMS Delhi  Room No 129 & 118, First Floor, A Wing, Department of Psychiatry
South West
DELHI 
9999267141

sujatasatapathy2022@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F840||Autistic disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  11.00 Year(s)
Gender  Both 
Details  Children
Male and female children aged 3-11 years
Children with borderline IQ and above.
Clinically diagnosed ASD and ASD with ADHD children
Parents written consent and children’s assent (if the child is able to read and write)
Health care professionals- Pediatric nurses, non-specialist physicians,and other health care professionals (e.g. clinical psychologists, child psychologists, social workers, occupational therapist, interns in pediatrics and psychiatry departments, etc) with an Android smart phone will be recruited. 30 % of all such health professionals will be included through a convenient sampling.
 
 
ExclusionCriteria 
Details  Children having clinical or medical diagnosis of comorbid psychiatric conditions, mental retardation, seizures or head injury, sensory impairments, and any major medical illness will be excluded from the study.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Cambridge Neuropsychological Test Automated Battery (CANTAB)   Baseline only  
 
Secondary Outcome  
Outcome  TimePoints 
Clinicians diagnosis  Baseline 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/12/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Summary of ASD-ADHD MobileApp ICMR Proposal

Many children with ASD also experience clinically-significant Attention deficit hyperactivity disorder (ADHD) symptoms. The observed cognitive impairments in ASD may be related to comorbid ADHD symptoms rather than shared genetic liability or core mechanisms. Some evidence using continuous symptom measures supports that impairments in response inhibition (Corbett et al., 2009; Yerys, Kenworthy, Jankowski, Strang, & Wallace, 2013) and arousal (Corbett et al., 2009) in ASD may be driven by comorbid ADHD symptoms, whereas ASD symptoms may contribute unique variance to processing speed (Yerys et al., 2013). However, studies are small and have included tasks with emotional face stimuli (Yerys et al., 2013), which may be uniquely related to ASD traits in ways that non-emotional and non-face stimuli are not, thus, it remains unclear. Here, we examine overlapping and distinct neuropsychological profiles of children with ADHD and ASD and evaluate the effects of dimensional symptom measures on neuropsychological profiles for both groups through this mobile-App.

Developmental screening can be done by a number of professionals in health care, community, and school settings. However, primary health care providers are in a unique position to promote children’s developmental health. Keeping the constraints of trained manpower and resources in view, a technology based early diagnosis tool will be a smart solution to save time, effort, cost, and resources and to reach out all children in multiple settings.

An ideal technology based Indian diagnostic tool for Autism and ADHD requires to be at least in the national language. It needs to be highly scalable; inexpensive; accurate; psychometrically robust; easy to administer; no issues with portability, maintenance, and storing; and errorless in recording data. It also needs to be multi-purpose; multi-setting, multi-users, multi-language. This proposed MobileApp will serve the purpose. Therefore, we want to develop a technology based Indian tool for early screening of two major neurodevelopmental disorders namely ASD and ADHD. Keeping the huge population of India in view, the number is huge and the ratio of specialist: children is very poor. Moreover, specialists are only available in large hospitals. Many government district level hospital do not have specialists such as psychiatrist or clinical psychologists. Nurses and other regular non-specialist health care professionals are the first point of reporting in any hospital, and if screening is done at that point, it will save lot of time, effort, and resources of the patients and hospital. A quick and validated tool which is technology enabled will ensure less human error and better data recording.

Aim: to develop and test psychometric properties of a Bi-lingual Mobile-App based Neuro-Cognitive Screening Tool for Early Identification of Children aged 3-11 years with Autism and ASD co-morbid with ADHD

Primary Objectives are to:-

·   Develop a bi-lingual neuro-cognitive assessment Mobile-App to be used by the nurse/health workers/non-specialist physicians for the early identification of Autism and autism-comorbid with attention deficit hyperactive disorder.

·   Find out the overlapping and distinct neuro-cognitive deficits in children with Autism and ADHD.

·   Test the Psychometric properties of this new tool taking samples from multiple centers.

Secondary objective: -

To compare the emotion recognition ability of both groups through visual-eye- movement tracking.

Hypotheses:

·      The newly developed mobile-App will be a psychometrically robust tool with ability to distinguish between children with and without ASD.

·      ASD group would show greater impairment than the ADHD group on set-shifting and working memory, but would have similar or less impairment than children with ADHD on measures of arousal, inhibitory control, and reward discounting. We do not expect ASD symptoms to account for cognitive impairments in ADHD, but would like to clarify whether ADHD symptoms accounted for cognitive impairments in ASD. The tool will be able to distinguish between ASD with ADHD and ASD without ADHD symptoms.

·      The tool will have robust psychometric properties.

·       The cut off will automatically highlight the screened cases for detailed evaluation and treatment.

Methodology

Sample and Sampling: All children between 3-11 years will constitute the universe of sample. Sample collection settings will be from Pediatrics and Psychiatry OPDs of 3 hospitals in Delhi. A total of 150 children with ASD, 100 with ADHD, and 150 without any neurodevelopmental disorders will be recruited following consecutive sampling technique.

Tools: Apart from personal and clinical proforma, separate tools will be used to measure IQ screening (Vineland Social Maturity Scale; VSMS) (Doll, 1935; Malin, 1971); participants’ motor dexterity, visuo-motor coordination, spatial organization, and speed and accuracy of performance Seguine Form Board Test (SFBT: Seguine, 1856); tools for divergent validity and convergent validity (Indian Scale for Assessment of Autism: ISAA, International Clinical Epidemiology Network (INCLEN) Diagnostic Tool for Indian Children with ASD (INDT-ASD: Juneja et.al., 2014); neurocognitive profile (Cambridge Neuropsychological Test Automated Battery :CANTAB or similar digital tool); and psychophysiological protocol standardization (Visual Tracking System).  

The procedure of MobileApp will be done through FGDs/key interviews with 15 non-health care professionals working with children in a hospital set up will be done to generate items regarding their basic understanding of the illness and its symptom profile.  A panel of expert using the modified Delphi technique will select the pool of items (Fischer, 1978). From the pool of items, the symptoms will be rank-ordered by the panel members, and further reduced using endorsement rate approach (Fitzpatrick, Davey, Buxton, Jones, 1998). Face and content validity will be found out. Necessary modifications will be incorporated.

Comparison: The non-specialist healthcare professionals will be compared for their accuracy of training on pre and post- MobileApp use. 

 
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