| CTRI Number |
CTRI/2025/10/095649 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How do children and adolescents with features of Attention deficit/hyperactivity disorder manage emotions, think and understand social situations |
|
Scientific Title of Study
|
Social functioning in children and adolescents with ADHD traits: the role of Emotional Regulation, Executive functions and Social cognition as mediators: An observational 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 |
Dr Insiya Patanwala |
| Designation |
Junior Resident, M.D. Psychiatry |
| Affiliation |
Kasturba Medical College, MAHE, Manipal |
| Address |
Department of Psychiatry, Kasturba Medical College, MAHE, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
8369115352 |
| Fax |
|
| Email |
patanwala.kmcmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savitha Soman |
| Designation |
Professor and HOD, Department of Psychiatry |
| Affiliation |
Kasturba Medical College, MAHE, Manipal |
| Address |
Department of Psychiatry, Kasturba Medical College, MAHE, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9845240653 |
| Fax |
|
| Email |
savitha.soman@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Insiya Patanwala |
| Designation |
Junior resident, M.D. Psychiatry |
| Affiliation |
Kasturba Medical College, MAHE, Manipal |
| Address |
Department of Psychiatry, Kasturba Medical College, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
8369115352 |
| Fax |
|
| Email |
patanwala.kmcmpl2024@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Psychiatry, Kasturba Medical College, MAHE, Madhav Nagar, Near Tiger circle, Manipal - 576104,
Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Insiya patanwala |
| Address |
The Department of Psychiatry, Kasturba Medical College, Tiger circle, Madhav Nagar, Manipal, Udupi, Karnataka 576104 |
| Type of Sponsor |
Other [self] |
|
|
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 Insiya Patanwala |
Kasturba Medical College |
Department of Psychiatry, Kasturba Medical College, MAHE, Tiger Circle, Madhav Nagar, Manipal, Udupi, Karnataka - 576104, India
Udupi
KARNATAKA |
8369115352
patanwala.kmcmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC and KH Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F90-F98||Behavioral and emotional disorders with onset usually occurring in childhood and adolescence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
11.00 Day(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1. ADHD traits present as measured by DSM 5 criteria, more than 4 symptoms in inattention domain and or more than 4 symptoms in hyperactivity or impulsivity domain.
2. Age of participants between 11 and 17 years and of any gender.
3. Seeking consultation under the Department of Psychiatry, KMC, Manipal.
4. Informed consent taken from parents.
5. Informed assent taken from adolescents, verbal assent from 11 to 12 years old and written assent from above 12 years old.
6. Minimum education of parents to be till primary school.
7. Parents and adolescents can speak and read English, Kannada or Hindi.
|
|
| ExclusionCriteria |
| Details |
1. Clinically diagnosed with moderate to severe mood disorders, anxiety disorders, personality disorders and psychotic spectrum disorders (as per DSM 5 TR level 1 cross cutting symptom measure for 11-17 years)
2. Clinically diagnosed with syndromal ASD, IDD using behavioural indicators of ICD11. (all levels of severity).
3. Any acute/ chronic medical condition that will impact their current emotional state like chronic pain conditions, endocrine disorders, neurological conditions such as uncontrolled seizure disorder.
4. Refusal to assent/consent for the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ADHD traits will be identified using DSM-5 criteria (more than 4 symptoms in either inattention or hyperactivity/impulsivity) |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Parents’ interview: SWAN ADHD, SDQ, and ICF Core Sets Interview
Children’s assessment: DERS-16, PEBL software tasks, and Faux Pas Recognition Test |
18 months |
|
|
Target Sample Size
|
Total Sample Size="145"
Sample Size from India="145"
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)
|
14/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/07/2027 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
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
|
1. Approval will be obtained from the Department of Scientific Committee and Institutional Ethics Committee of KMC, and the study will be registered at the Clinical Trial Registry of India. 2. Participants will be recruited after IEC clearance based on predefined inclusion and exclusion criteria, with informed consent from parents and assent from adolescents. 3. Participants meeting criteria for significant ADHD traits will undergo assessment of key study variables. 4. Parents will provide sociodemographic information and complete the SWAN ADHD and Strengths and difficulties questionnaire, and participate in an interview to assess the child’s social functioning. 5. Children and adolescents will complete the DERS-16, PEBL tests, and the Faux Pas Recognition Test to assess emotional regulation, executive function, and social cognition. 6. Data collection will follow strict ethical guidelines, with all information kept confidential. 7. Statistical analyses will be performed to explore relationships between study variables and test hypotheses. |