| CTRI Number |
CTRI/2024/09/074428 [Registered on: 26/09/2024] Trial Registered Prospectively |
| Last Modified On: |
21/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Disability in adults with ADHD |
|
Scientific Title of Study
|
Cross sectional study to evaluate disability among adults with ADHD |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sona Jose |
| Designation |
Postgraduate Psychiatry Resident |
| Affiliation |
St. Johns Medical College Hospital |
| Address |
Department of Psychiatry
St Johns medical college hospital , Sarjapur road
Bangalore
KARNATAKA
560034
India |
| Phone |
08606186305 |
| Fax |
|
| Email |
sonajose17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPriya Sreedaran |
| Designation |
Professor,Department of Psychiatry |
| Affiliation |
St. Johns Medical College Hospital |
| Address |
Department of Psychiatry
St Johns medical college Hospital , Sarjapur road
Bangalore
KARNATAKA
560034
India |
| Phone |
08022065570 |
| Fax |
|
| Email |
drpriyasreedaran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrPriya Sreedaran |
| Designation |
Professor,Department of Psychiatry |
| Affiliation |
St. Johns Medical College Hospital |
| Address |
Department of Psychiatry
St Johns medical college Hospital , Sarjapur road
Bangalore
KARNATAKA
560034
India |
| Phone |
08022065570 |
| Fax |
|
| Email |
drpriyasreedaran@gmail.com |
|
|
Source of Monetary or Material Support
|
| St.Johns Medical College Hospital,Sarjapur Road,Bangalore
560034, India
|
|
|
Primary Sponsor
|
| Name |
DrSona Jose |
| Address |
Department of Psychiatry
St Johns medical college hospital , Sarjapur road |
| Type of Sponsor |
Other [Self-funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSona Jose |
St. Johns Medical College Hospital |
Psychiatry Common ward and private ward , First and second floor ; Psychiatry OPD ,Room number 27
Department of Psychiatry
Bangalore
KARNATAKA |
8606186305
sonajose17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe,SJMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F902||Attention-deficit hyperactivity disorder, combined type, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with ADHD
Age group between 18 years to 45 years |
|
| ExclusionCriteria |
| Details |
Patients with active psychotic episodes as per ICD diagnostic and research criteria
Patient with active manic episode,autism spectrum disorder,severe depression ,severe anxiety as per ICD diagnostic and research criteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To understand level of disability
|
once |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To describe clinical profile and pathway to care |
once |
|
|
Target Sample Size
|
Total Sample Size="97"
Sample Size from India="97"
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)
|
10/10/2024 |
| 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="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sonajose17@gmail.com].
- For how long will this data be available start date provided 19-08-2024 and end date provided 19-08-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Atention deficit hyperactivity disorder is a neurodevelopmental disorder characterised by
persistent and pervasive patterns of inattention, hyperactivity and impulsivity. It is estimated to
affect 2.49% of adults globally. The symptoms often appear in childhood before the age of 12 and
has a considerable impact on academic performance and social behaviours. These symptoms
may continue to occur as the child grows up although the presentation may
vary .Inattention .hyperactivity and impulsivity can manifest in different aspects of an adult life
deterring their quality of life. Some common challenges associated with this conditions are
difficulties in time management, organization and focusing on tasks. Emotional dysregulation
and executive functioning related symptoms are also noted among adults. Many a times ADHD
is
associated with other psychiatric comorbidities, making the diagnosis difficult and
delayed.[11].A detailed evaluation of the symptoms and its effects on their life will help in
curating appropriate treatment measures for adults with ADHD .Insufficient data on ADHD -related disability in adults makes it challenging to assess and
address their specific needs effectively. Research gaps highlight the importance of further studies
to enhance understanding and support for population. Examining the phenomenology of ADHD
is
crucial for a comprehensive understanding of the disability it may pose. A nuanced
understanding of diverse disabilities ,including ADHD is essential for developing targeted and
effective interventions. Primary aim is to evaluate disability among adults with ADHD and secondary objective is to describe the clinical profile and the pathway to care of adults with ADHD |