| CTRI Number |
CTRI/2025/11/097412 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [psychosocial Intervention ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Psychosocial Support Improves Parenting and Reduces Defiant Behavior in Kids. |
|
Scientific Title of Study
|
Impact of Psychosocial Intervention on Oppositional Defiant Disorder Symptoms and Parenting outcomes among Parents of School-age Children. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Supriya |
| Designation |
PhD N Scholar |
| Affiliation |
Teerthanker Mahaveer College of Nursing |
| Address |
Teerthanker Mahaveer College of Nursing, TeerthankerMahaveer University, NH-24, Bagarpur, Delhi Road, Moradabad
UTTAR PRADESH
244001
India
Teerthanker Mahaveer College of Nursing, TeerthankerMahaveer University, NH-24, Bagarpur, Delhi Road,
Moradabad
UTTAR PRADESH
244001
India
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7006954144 |
| Fax |
|
| Email |
supriyasharmamsc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr M Jasline |
| Designation |
Principal |
| Affiliation |
Teerthanker Mahaveer College of Nursing |
| Address |
Room No 109, Ground Floor, Teerthanker Mahaveer College of Nursing, TeerthankerMahaveer University, NH-24, Bagarpur, Delhi Road, Moradabad
UTTAR PRADESH
244001
India
Room No 109, Ground Floor, Teerthanker Mahaveer College of Nursing, TeerthankerMahaveer University, NH-24, Bagarpur, Delhi Road,
Moradabad
UTTAR PRADESH
244001
India
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8279816167 |
| Fax |
|
| Email |
drjaslinejohn.msn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Supriya |
| Designation |
PhD N Scholar |
| Affiliation |
Teerthankar Mahaveer University |
| Address |
Teerthankar Mahaveer University NH-24 Bagarpur,Delhi Road Moradabad Uttar Pradesh India
Teerthankar Mahaveer University NH-24 Bagarpur,Delhi Road Moradabad Uttar Pradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7006954144 |
| Fax |
|
| Email |
Supriyasharmamsc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Block Office Katra,District Reasi,Jammu and Kashmir, India.
Pin Code 182301 |
|
|
Primary Sponsor
|
| Name |
Supriya |
| Address |
PhD Section, Ground Floor, Teerthanker Mahaveer College of Nursing, TeerthankerMahaveer University, NH-24, Bagarpur, Delhi Road, Moradabad |
| 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 |
| Supriya |
Katra Block,J&K |
Katra Block,District Rasi Jammu,J&K
Jammu
JAMMU & KASHMIR |
7006954114
supriyasharmamsc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONALETHICSCOMMITTEE,TEERTHANKERMAHAVEERDENTALCOLLEGE &RESEARCHCENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
the parents of School age children with sign and symptoms of Oppositional Defiant Disorder |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONTROL GROUP |
The control group will not receive the structured psychosocial intervention (Parent Management Training) during the study period However to ensure ethical parity participants may be offered the PMT program after the study concludes contingent upon its demonstrated effectiveness During the 3 month study period parents in the control group will receive general parenting advice from the researchers through scheduled sessions (one session per week approximately 60 minutes each)focusing on child development and behavioral awareness without incorporating specific PMT techniques |
| Intervention |
Psychosocial Intervention |
The psychosocial intervention in this study refers to a structured Parent Management Training (PMT) program designed by the investigator to help parents develop effective parenting strategies for addressing Oppositional Defiant Disorder (ODD) symptoms in their children.
The intervention aims to enhance parent child efficacy by equipping parents with practical techniques for behaviour modification and managing challenging behaviors
Parents of school-aged children (6–12 years) whose children are identified as being at risk for ODD symptoms will be recruited for the study
The PMT program will consist of 12 sessions, delivered over a period of 3 months ( one session per week, each lasting approximately 60 minutes)
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Parents (mother, father, or both) of school-aged children (6–12 years) who are at risk for ‘‘Oppositional Defiant Disorder’’ (‘‘ODD’’) symptoms, as identified through standardized screening tools (e.g., CBCL, DSM-5 criteria).
Parents who are willing to participate in the study and commit to attending all sessions of the psychosocial intervention.
Parents who provide informed written consent to participate in the study and receive the intervention.
Parents who have basic literacy skills (i.e., able to read and understand Hindi or English) sufficient to comprehend instructions, intervention content, and complete self-report tools.
|
|
| ExclusionCriteria |
| Details |
Parents whose child has a diagnosed neurodevelopmental or psychiatric disorder other than Oppositional Defiant Disorder. This includes, but is not limited to:
- Conduct Disorder
- Autism Spectrum Disorder
- Attention-Deficit/Hyperactivity Disorder
- Psychotic Disorders
- Intellectual Disability (previously referred to as mental retardation)
Parents who are unwilling or unable to provide informed written consent or who cannot commit to attending the full duration of the psychosocial intervention program.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in oppositional defiant disorder symptoms |
91st day and 130th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in parent stress |
91st day and 130th day |
| Improve parent efficacy |
91st day and 130th day |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2026 |
| 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="11"
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
|
This study is a randomised control trial with the aims to find out whether a psychosocial intervention can reduce oppositional defiant disorder (ODD) symptoms, parental stress and improve the parenting efficacy. The study will determine the long-term impact of psychosocial interventions by conducting follow-up assessments. We hypothesize that the positive effects of psychosocial intervention on ODD symptoms, parental stress levels, parenting efficacy, will be sustained over time, with significant improvements observed at follow-up assessments.
|