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CTRI Number  CTRI/2024/08/072439 [Registered on: 13/08/2024] Trial Registered Prospectively
Last Modified On: 06/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Attention training for brain functions in children with Attention and hyperactivity problems 
Scientific Title of Study   Effectiveness of Attention Enhancement Task on Executive Functions in Children with Attention Deficit Hyperactive Disorder-A Randomized Controlled Trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jeeshma Vijin 
Designation  Assistant Professor 
Affiliation  Manipal College of Health Professions 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of higher Education, Bangalore, Karnataka
Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Bangalore, Karnataka
Bangalore
KARNATAKA
560017
India 
Phone  08217723829  
Fax    
Email  jeeshma.vijin@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr H Karvannan 
Designation  Associate Professor and HOD 
Affiliation  Manipal College of Health Professions 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Bangalore, Karnataka
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Bangalore, Karnataka
Bangalore
KARNATAKA
560017
India 
Phone  09986565966  
Fax    
Email  karvannan.h@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr H Karvannan 
Designation  Associate Professor and HOD 
Affiliation  Manipal College of Health Professions 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Bangalore, Karnataka
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Bangalore, Karnataka
Bangalore
KARNATAKA
560017
India 
Phone  09986565966  
Fax    
Email  karvannan.h@manipal.edu  
 
Source of Monetary or Material Support  
No.98, Rustam Bagh Road, Old Airport Road, Department of Clinical Psychology, Manipal College of Health Professions,Manipal Academy of Higher Education, Bangalore 560017 
 
Primary Sponsor  
Name  Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal 
Type of Sponsor  Research institution and hospital 
 
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 
Jeeshma Vijin  Manipal Hospitals, Bangalore  Department of Clinical Psychology, Outpatient Service, Upper Basement, Manipal Hospital #98,HAL Old Airport Road,Bangalore
Bangalore
KARNATAKA 		 09739057361

jeeshma.vijin@manipal.edy 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of Manipal Hospitals Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F90||Attention-deficit hyperactivity disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Attention Enhancement Task  The Attention enhancement task is based on a digit symbol substitution test with some variations, participants need to draw lines inside the forms, and it is usually provided on paper.Performance is rated on a four-point scale.difficulty level can be increased by increasing the total number of codes in each set or by moving on to the next set. Training frequency-5days/week for 8 weeks, each session lasting 1 hour. 
Comparator Agent  Self-instruction training  The self-instruction training will be taught in five steps: “(a) stop and observe;(b) questions about the task (c) answers to questions about the task(d) self-instruction to guide through the task (e) self-acknowledgement of work accomplished. Five worksheets will be utilized in the training. The worksheets used are: finding the same, maze, size sequencing, sequencing to tell a action, and determining what is missing from an image. Training frequency -5days/week for 8 weeks, each session lasting 1hour. 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Children diagnosed with attention deficit hyperactivity disorder
2.Age group 5years to 12 years
3.Both genders
 
 
ExclusionCriteria 
Details  1.Other neurodevelopmental disorders like autism and intellectual disabilities.
2.Children with other behavioral problems or self-injurious behavior
3.Children on medication
4.Children who enrolled or completed behavioral or cognitive interventions within last 3 months
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Behavior Rating Inventory of Executive Function (BRIEF)
 		 1.At baseline(0weeks), End of the treatment(8weeks),Follow up(8weeks)
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Vanderbilt ADHD Parent Rating Scale
2.Children Color Trail Test
3.GO/NO-GO Task
 		 1.At baseline(0weeks), End of the treatment(8weeks),Follow up(8weeks)
2.At baseline(0weeks), End of the treatment(8weeks),Follow up(8weeks)
3.At baseline(0weeks), End of the treatment(8weeks),Follow up(8weeks) 
 
Target Sample Size   Total Sample Size="114"
Sample Size from India="114" 
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)   01/10/2024 
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)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Attention Deficit Hyperactive disorder (ADHD) is a developmental disorder that develops in childhood. Inattention, hyperactivity, and impulsivity are the key characteristics of ADHD. Despite being a developmental disorder, in many cases ADHD is diagnosed in third or fourth grade when academic demands increase, resulting in academic difficulties and, eventually, behavioral issues. 


The deficits in executive functions (EFs) like cognitive inflexibility are primary cause for functional impairment and related psychopathology in ADHD. When EFs are impaired, it may be difficult to plan and organize tasks, stay on schedule, and keep concentrate despite distractions. As a result, emerging adults with executive dysfunction who do not meet societal expectations at this time of life are more likely to develop psychopathology. Hence it is important to address executive function along with behavioral symptoms in ADHD.
The executive function is associated with at least one attention domain. As a result, attention is one of the most important components for higher cognitive functioning. Therefore, attention training may strengthen the attention network while also improving performance in untrained tasks such as cognitive function and behavioral symptoms. However, there is inconsistent literature review on transferability in attention training. Furthermore, there is inadequate knowledge regarding how attention-enhancing tasks could help with executive function, which is hampered in ADHD. Thus, the present study has focused to understand the effectiveness of attention enhancement task in improving executive function.



 
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