| CTRI Number |
CTRI/2025/07/091267 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
19/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the efficacy of group based parent skill training intervention on children with adhd, a randomised tele based study
in drug naive children with Attention deficit hyperactivity disorder: A comparative, tele-based randomized control trial |
|
Scientific Title of Study
|
To study the efficacy of group based parent skill training intervention
in drug naive children with Attention deficit hyperactivity disorder: A comparative, tele-based randomized control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 1 |
NIL |
| 1 |
Other |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
jyotika |
| Designation |
junior resident |
| Affiliation |
PGIMER |
| Address |
Postgraduate Institute of Medical Education and Research Sector 12,Chandigarh
1204,SECTOR 15B,CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7397965890 |
| Fax |
|
| Email |
jyotikakanwar1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Akhilesh sharma |
| Designation |
consultant |
| Affiliation |
PGIMER |
| Address |
Postgraduate Institute of Medical Education and Research Sector 12,Chandigarh
1204,SECTOR 15B,CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9873704924 |
| Fax |
|
| Email |
drakhileshsharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akhilesh sharma |
| Designation |
consultant |
| Affiliation |
PGIMER |
| Address |
Postgraduate Institute of Medical Education and Research Sector 12,Chandigarh
1204,SECTOR 15B,CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9873704924 |
| Fax |
|
| Email |
drakhileshsharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education chandigarh
though no monetary grand is required |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Medical Education and Research Sector Chandigarh |
| Address |
Postgraduate Institute of Medical Education and Research Sector 12,Chandigarh |
| Type of Sponsor |
Research institution |
|
|
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 jyotika |
Postgraduate Institute of Medical Education and Research Sector 12,Chandigarh |
Postgraduate Institute of Medical Education and Research Sector 12,Chandigarh
1204,SECTOR 15B,CHANDIGARH
Chandigarh
CHANDIGARH |
07397965890
jyotikakanwar1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate institute of medical education and research chandigarh ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NONE |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
intervention vs control |
Drug naive Children aged 4-12 years diagnosed with ADHD as per DSM 5 , receiving TAU/standard care, attending the child and adolescent psychiatry services and advanced paediatric centre will be approached. These children and their parents will be explained the purpose of the study in brief. Those agreeing to participate in it will be inducted and tools (DSM 5) will be applied as a screening tool. Parents will be explained about the aims and objectives of the study and a written consent will be taken from the parents whereas assent from child will be taken. Diagnosis of ADHD will be confirmed using MINI KID (7.2.0) and children will also be screened for any other neurodevelopmental disorder and/or any other psychiatric disorder using the same instrument. A number of approximately 50 children will be included (based on inclusion and exclusion criteria ) out of which 2 groups will be formulated based on Randomisation (random allocation concealment); 25 children in each group
Group A - Intervention group n=50 children and their parents)
Group B – Control group n=50 children and their parents
|
| Intervention |
To study the efficacy of group based parent skill training intervention in children with Attention deficit hyperactivity disorder; A randomised , tele-based study |
Aim: To study the efficacy of group-based parent skill training intervention (PSTI)in children with ADHD receiving standard care (i.e. intervention group) vs Children with ADHD receiving Standard care alone (i.e., control group) in clinical setting.
Objectives:
Primary : To compare efficacy of groups receiving PSTI (Parent skill training interventions) with standard care versus standard care alone on SDQ
Secondary: A. To assess the efficacy of PSTI on parent related parameters (Parenting ,parenting stress ,parental child interaction) B. Child related parameters (Behavioural problems and functioning)
Null Hypothesis: There will be no change in core symptoms of ADHD measured on SDQ total score in children with ADHD receiving parent training interventions in the clinic over time.
Alternative Hypothesis: There will be change in core symptoms of ADHD measured on SDQ total score in children with ADHD receiving parent training interventions in the clinic over time.
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
those who give consent
do not have comorbities
those who have a smart phone
|
|
| ExclusionCriteria |
| Details |
those who dont have a smart phone
those who dont given consent
no medical comorbities |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| changes on core symptoms of ADHD at baseline and 20 weeks post intervention |
On behavioural symptoms
parental stress competence and positive parenting |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| parental stress competence and positive parenting |
0 and 20 weeks |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
03/07/2026 |
| 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="0"
Months="5"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
There is a very low number of studies involving ADHD children, particularly in low-middle/developing countries, with a few studies from India even though, a substantial population of children with ADHD have behavioural problems. Given WHO’s imperative to generate cross-cultural evidence for the efficacy of interventions crucial from a public health perspective, it becomes necessary to address this research gap. Preliminary groundwork on adaptation, acceptability, and feasibility of such interventions as well as an open label ,non-randomised trial has already been undertaken increasing the need for broader studies to inform effective and culturally sensitive interventions for children with ADHD in diverse settings.No RCT has been done in India |