| CTRI Number |
CTRI/2026/02/103206 [Registered on: 06/02/2026] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Factors Affecting Adherence to Medication in Children and Adolescents with Attention Deficit Hyperactivity Disorder (ADHD) |
|
Scientific Title of Study
|
Factors affecting adherence to pharmacotherapy in children and adolescents with Attention Deficit Hyperactivity Disorder – a cross-sectional descriptive study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Satya Rama Vikramaditya Tennety |
| Designation |
Post Graduate Student |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
OPD No. 15, 1st Floor, KLES Dr. Prabhakar Kore Charitable Hospital and Research center, Nehru Nagar, Belagavi,
Belgaum
KARNATAKA
590010
India |
| Phone |
7032557647 |
| Fax |
|
| Email |
aditya1080@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Satya Rama Vikramaditya Tennety |
| Designation |
Post Graduate Student |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
OPD No. 15, 1st Floor, KLES Dr. Prabhakar Kore Charitable Hospital and Research center, Jawaharlal Nehru Medical College, KLE University, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
7032557647 |
| Fax |
|
| Email |
aditya1080@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
SATYA RAMA VIKRAMADITYA TENNETY |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
JAWAHARLAL NEHRU MEDICAL COLLEGE, KLE UNIVERSITY, NEHRU NAGAR, BELAGAVI
KARNATAKA
590010
India |
| Phone |
7032557647 |
| Fax |
|
| Email |
aditya1080@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Satya Rama Vikramaditya Tennety |
| Address |
001, First Floor, Om Home, Shivabasava Nagara, Nehru Nagar, Belagavi, 590010, Karnataka |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
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 |
| Dr Sandeep Patil |
KLES Dr. Prabhakar Kore Charitable Hospital And Research Center |
OPD No. 15, First Floor KLES DR. Prabhakar Kore Charitable Hospital and Research Center, Nehru Nagar, Belagavi, 590010
Belgaum
KARNATAKA |
7353201136
sandeep04m1108@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTEE |
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 |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
Children and adolescents diagnosed with Attention Deficit Hyperactivity Disorder defined by Diagnostic and Statistical Manual for Mental Disorders 5 Text Revision criteria.
Children whose parents or guardians can give informed consent.
|
|
| ExclusionCriteria |
| Details |
•Children and adolescents with comorbid medical and neurological conditions.
•Children and adolescents diagnosed with Intellectual Development Disorder
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the proportion of participants adherent to medication. |
1 YEAR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of prescribing practices on adherence to medications in ADHD. |
1 YEAR |
| To assess factors influencing adherence to medication |
1 YEAR |
|
|
Target Sample Size
|
Total Sample Size="89"
Sample Size from India="89"
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)
|
20/02/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder of childhood and adolescence, for which pharmacological treatment remains a cornerstone of management. Despite proven efficacy, suboptimal medication adherence is frequently observed, leading to poor clinical outcomes. This study aims at understanding the factors affecting adherence to pharmacotherapy so they can be applied by clinicians to strategize treatment plans for their patients. |