| CTRI Number |
CTRI/2024/11/077057 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Mixed Methods Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of ACE of Parents on their Child Behaviour |
|
Scientific Title of Study
|
Association of Parent’s Adverse Childhood Experiences and Mental Health Dysfunction with Children Behavioral Outcomes in Urban Jodhpur: A Mixed-Methods 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 Neeti Rustagi |
| Designation |
Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Room no 205,
Department of Community Medicine and Family Medicine,
Medical College Block
All India Institute Of Medical Sciences (AIIMS) Basni Industrial Area Phase 2. Jodhpur
342005
India
All India Institute Of Medical Sciences (AIIMS), Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996931 |
| Fax |
|
| Email |
drneetigoswami@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishit Chaudhary |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences (AIIMS), Jodhpur |
| Address |
Room no 210,
Department of Community Medicine and Family Medicine,
Medical College Block
All India Institute Of Medical Sciences (AIIMS) Basni Industrial Area Phase 2.,Jodhpur
342005
India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9915453683 |
| Fax |
|
| Email |
nishitchaudhary1998@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishit Chaudhary |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences (AIIMS), Jodhpur |
| Address |
Room no 210,
Department of Community Medicine and Family Medicine,
Medical College Block
All India Institute Of Medical Sciences (AIIMS) Basni Industrial Area Phase 2.,Jodhpur
342005
India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9915453683 |
| Fax |
|
| Email |
nishitchaudhary1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Jodhpur, Marudhar Industrial Area, 2nd Phase, M.I.A 1st Phase, Basni, Jodhpur, Rajasthan, India-342005 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Nishit Chaudhary |
All India Institute of Medical Sciences |
Room 205, Second Floor, Medical College Building
Jodhpur
RAJASTHAN |
9915453683
nishitchaudhary1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,All India Institute of Medical Sciences, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Either Parent of children aged 6 to 17 years residing in Jodhpur. |
|
| ExclusionCriteria |
| Details |
1. Parents not residing with their children.
2. Parents of children with established developmental delays due to any reason. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To estimate the burden of adverse childhood experiences among parents of children aged 6-17 years in urban Jodhpur. To assess the burden of mental health dysfunction (depression, anxiety, and stress) among parents of children aged 6-17 years. To determine the burden of behavioral outcomes among their children. To analyze the association of adverse childhood experiences and mental health
dysfunction among parents of children aged 6-17 years with child behavior outcomes. |
After the data collection 18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study factors affecting professional help seeking intentions among parents of children with problematic behavior. |
At the end of data collection 18 months |
|
|
Target Sample Size
|
Total Sample Size="468"
Sample Size from India="468"
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)
|
27/11/2024 |
| 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="4"
Days="18" |
|
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
|
Adverse childhood experiences (ACEs) are traumatic events during childhood that harm cognitive and emotional development. These experiences, whether at home, school, or within the community, affect children’s behavioral outcomes.A significant dose-response association exists between ACE exposure and higher odds of moderate to severe depression, anxiety, high stress, and lower well-being. This underscores the need to investigate ACEs’ impact on mental health within the Indian population. The study aims to explore the link between parents’ ACEs, mental health issues, and their children’s behavioral outcomes, focusing on externalizing and internalizing behaviors, and social and academic challenges. |