| CTRI Number |
CTRI/2025/04/085782 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
26/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Brief intervention package on Acceptance and Committnent] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Brief interventional package on Acceptance and Commitment therapy |
|
Scientific Title of Study
|
A Randomized controlled trial to assess effectiveness of brief interventional package on Acceptance and Commitment therapy (ACT) on selected outcome variables among parents of children with neurodevelopmental disorders (NDD) attending Psychiatry unit ,PGIMER,Chandigarh.(2024-2026) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Monika Bhardwaj |
| Designation |
M.Sc. Nursing student |
| Affiliation |
National Institue of Nursing, PGIMER,Chandigarh |
| Address |
Room no.208 National Institute of Nursing education,PGIMER,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09717702560 |
| Fax |
|
| Email |
monikabhardwaj666@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita Sharma |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Nursing education,PGIMER,Chandigarh |
| Address |
Room no.210 National Institute of Nursing education,PGIMER,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9876269615 |
| Fax |
|
| Email |
sanitasuni@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
MsRenu Sharma |
| Designation |
Tutor |
| Affiliation |
National Institute of Nursing education,PGIMER,Chandigarh |
| Address |
Room no.309 National Institute of Nursing education,PGIMER,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9988330964 |
| Fax |
|
| Email |
rain_nsg@yahoo.com |
|
|
Source of Monetary or Material Support
|
| No monetary support |
| Post graduate institute of medical Education and Research ,Sector 12,Chandigarh,160012,India |
|
|
Primary Sponsor
|
| Name |
Monika Bhardwaj |
| Address |
National Institute of Nursing Education,PGIMER,Chandigarh ,pin code 160012,India |
| Type of Sponsor |
Other [Interventional ] |
|
|
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 |
| DrAkhilesh Sharma |
Post graduate institute of medical education and research Chandigarh |
Drug Deaddiction and treatment centre Room no.226
Chandigarh
CHANDIGARH |
6239124451
drakhileshsharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post graduate Institute of Medical Education and research ,Chandigarh Institutional Ethics Committee(Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Parents of children with neurodevelopmental disorder |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brief intervention on acceptance and commitment therapy |
Acceptance and commitment therapy will be conducted in three sessions.The duration of the session will vary from 40-50 mins.
Six components of ACT that is committed actions ,acceptance ,values ,self as context ,cognitive diffusion and mindfullness will be in the therapy to increase the psycholgical flexibility of parents of children with NDD.
|
| Comparator Agent |
routine care |
Routine care includes counselling session and psychoeducation already being given to parents. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Parents of children with NDD and willing to participate and able to understand Hindi, English and Punjabi |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| parental stress |
8 weeks (endline assessment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| parental stress, parental aggression |
1.At the day of enrollment
2.follow up 15 days and 1month
endline assessment after 2 months
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| Date of Study Completion (India) |
12/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
12/12/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Objective of the study is to enhance the psychological flexibility of the parents of children with Neurodevelopment disorder. The design of this study is Randomized controlled trial and psychological flexibility, Parental stress and parental aggression will be assessed with standardized tool Parental Acceptance questionnaire, parental stress scale, Self compassion scale, parent child conflict tactics scale and aggression questionnaire. The brief intervention on acceptance and commitment therapy will be administered and expected outcome will be increased psychological flexibility and reduction of stress among parents of children with NDD. |