| CTRI Number |
CTRI/2025/09/094881 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
13/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Parental Guidance and Counselling to Reduce Behavior Problems in Preschool Children |
|
Scientific Title of Study
|
Impact of parental guidance and counselling program on management of Behavioral problems and its determinants among preschool 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 |
Nisha Mane |
| Designation |
Ph.D Scholar |
| Affiliation |
Krishna Vishwa Vidyapeth(Deemed to be University) |
| Address |
Department: Child Health Nursing
Institution: Krishna Institute of Nursing Sciences
University: Krishna Vishwa Vidyapeeth (Deemed to be University)
Karad, District Satara, Maharashtra, India
Department: Child Health Nursing
Institution: Krishna Institute of Nursing Sciences
University: Krishna Vishwa Vidyapeeth (Deemed to be University)
Karad, District Satara, Maharashtra, India
Satara
MAHARASHTRA
415539
India |
| Phone |
08655004944 |
| Fax |
|
| Email |
nishamane167@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prakash Naregal |
| Designation |
Associate Professor - Ph. D Guide |
| Affiliation |
Krishna Institute of Nursing Scienes, Karad |
| Address |
Department: Child Health Nursing
Institution: Krishna Institute of Nursing Sciences
University: Krishna Vishwa Vidyapeeth (Deemed to be University)
Department: Child Health Nursing
Institution: Krishna Institute of Nursing Sciences
University: Krishna Vishwa Vidyapeeth (Deemed to be University)
Satara
MAHARASHTRA
415539
India |
| Phone |
08983279722 |
| Fax |
|
| Email |
Prakash.naregal20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nisha Mane |
| Designation |
Ph.D Scholar |
| Affiliation |
Krishna Institute of Nursing Scienes, Karad |
| Address |
Department- Child Health Nursing
Institution- Krishna Institute of Nursing Sciences
University- Krishna Vishwa Vidyapeeth Deemed to be University
Department-Child Health Nursing
Institution-Krishna Institute of Nursing Sciences
University- Krishna Vishwa Vidyapeeth Deemed to be University
Satara
MAHARASHTRA
415539
India |
| Phone |
08983279722 |
| Fax |
|
| Email |
Prakash.naregal20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Krishna Vishwa Vidyapeth(Deemed to be University) |
|
|
Primary Sponsor
|
| Name |
Krishna Vishwa Vidyapeth(Deemed to be University) |
| Address |
Malkapur, Karad (Dist.Satara), Maharashtra, India. PIN - 415539 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Nisha Mane |
Anganwadi Centers |
Raigarh Districts
Raigarh
MAHARASHTRA |
8655004944
nishamane167@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe,under Krishna Institute of Medical Sciences Deemed to be Universitye, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
parents of preschool children with mild behavioural problems |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Guidance and counselling program |
Structured nurse-led parental guidance and counselling program for parents of preschool children Face-to-face interactive sessions, demonstrations, and discussions conducted in the community settings |
| Comparator Agent |
Routine care at home health education pamplet will be provided |
Parents in the control group will receive only the usual health education and routine advice |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Parent of preschool child available during the time of data collection.
Parent able to read and write English, hindi and Marathi
Preschool child with mild behavioral disorder
|
|
| ExclusionCriteria |
| Details |
• Preschool children those are on treatment due to any mental health reason.
• Parental having any formal education on behavioural disorders in children
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Primary Outcome(s):
Behavioral problems among preschool children will be assessed at the point of data collection as survey
2. Identification of determinants associated with behavioral problems in preschool children.
|
1. Primary Outcome(s):
Reduction in behavioral problems among preschool children as measured by a validated tool.
Time Points:
Baseline (prior to intervention), at 4 weeks, and at 8 weeks after intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2. potentially mitigating the long-term consequences of untreated behavioral issues.
3. The study also will contributes to the growing body of research on early childhood development and behavioral interventions.
4. Findings from such studies can inform the development of evidence-based policies and programs aimed at supporting families and promoting positive outcomes for preschool children
|
|
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
25/09/2025 |
| 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="3"
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
|
Impact of parental guidance and counselling program on management of behavioral problems and its determinants among pre-school children ABSTRACT Context: Parents have a significant influence over their children’s behavior. Programs aimed at educating and supporting parents can offer strategies to address behavioral issues and promote a positive home environment. Aims: The study aims to evaluate the effects of a parental guidance and counseling program on managing behavioral problems among preschool children. Settings and Design: Quasi-experimental research will be conducted in various Anganwadi centers in Raigad District. Subjects and Methods: The study will involve preschool children (ages 3-6) and their parents from selected Anganwadi’s in Raigad District. Purposive sampling will be used to select participants. After selection, parents will be randomly assigned to either an experimental group or a control group. The experimental group will receive guidance and counseling sessions focused on managing preschool behavioral problems and understanding their underlying causes. Both groups will undergo an initial assessment, followed by a post-test one week after the intervention. Behavioral changes in preschool children will be evaluated at one-month and three-month intervals. Conclusions: This study will raise the awareness of parents on behavioral issues in preschool children and their contributing factors.
|