| CTRI Number |
CTRI/2025/08/093225 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating a Parenting Program for Primary Caregivers of Young Children to Improve Parenting Skills and Child Wellbeing |
|
Scientific Title of Study
|
Parenting for Lifelong Health: Adaptation & Feasibility study of a Parenting Program for Primary Caregivers of Young 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 |
Jadhav Monali Ashok |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Mental Health and Neuro Sciences (NIMHANS) |
| Address |
Department of Clinical Psychology, MV Govindaswamy Building,
National Institute of Mental Health and Neuro Sciences (NIMHANS)
Bangalore
KARNATAKA
560029
India |
| Phone |
9637873409 |
| Fax |
|
| Email |
mjadhav2007@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Jadhav Monali Ashok |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Mental Health and Neuro Sciences (NIMHANS) |
| Address |
Department of Clinical Psychology, MV Govindaswamy Building,
National Institute of Mental Health and Neuro Sciences (NIMHANS)
Bangalore
KARNATAKA
560029
India |
| Phone |
9637873409 |
| Fax |
|
| Email |
mjadhav2007@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Jadhav Monali Ashok |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Mental Health and Neuro Sciences (NIMHANS) |
| Address |
Department of Clinical Psychology, MV Govindaswamy Building,
National Institute of Mental Health and Neuro Sciences (NIMHANS)
Bangalore
KARNATAKA
560029
India |
| Phone |
9637873409 |
| Fax |
|
| Email |
mjadhav2007@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jadhav Monali Ashok |
| Address |
Clinical Psychology, NIMHANS, Bengaluru, Karnataka, India 560030 |
| 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 |
| Jadhav Monali Ashok |
Munsyari |
Munsyari
Pithoragarh
UTTARANCHAL |
09637873409
mjadhav2007@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Departmental Sub Ethics Committee, National Institute of Mental Health and Neurosciences NIMHANS |
Approved |
| Institutional Ethics Committee, National Institute of Mental Health and Neurosciences(NIMHANS) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No self-report of any history of any Severe Mental Illness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Parenting for Lifelong Health – Young Children program (PLH-YC) |
Adapt the Parenting for Lifelong Health – Young Children program developed by collaboration between the World Health Organization (WHO), UNICEF, University of Cape Town in South Africa and the University of Oxford.
The adapted intervention will then be delivered by trained community health workers (CHWs) to the primary caregivers. The primary caregivers will learn positive parenting skills in a group setting using stories, discussions, role-plays, and home activities.
The program will focus on four main areas:
1. Relationship Building: Encouraging child-led play and open conversations about feelings.
2. Positive Reinforcement: Teaching primary caregivers to praise and reward good behaviour.
3. Setting Limits: Helping primary caregivers create routines, clear rules, and give specific instructions.
4. Positive Discipline: Using non-violent ways to manage difficult behaviour.
Each group of primary caregivers will have 8–15 participants and it will be facilitated by two CHWs. Once a week session will be held. Each session will be conducted over one and a half to two hours.
The total duration of the intervention will be between 4 to 10 weeks, with one session conducted each week. The exact number of sessions will be finalized based on the adaptation and pilot testing findings. Each session will be held in a group setting and facilitated by trained community health workers. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Primary caregivers
1) At least one child in the age group of 4 – 9 yrs. old
2) Can comprehend, speak, read and write Hindi &/ or English
Community Health Workers (CHWs) who are Willing to volunteer to undergo training and later to facilitate group sessions with parents/primary caregiver
1) ASHA workers, Anganwadi workers, or any other cadre working as Community Health Workers (CHWs)
2) Able to comprehend, speak, read, and write in Hindi and/or English
|
|
| ExclusionCriteria |
| Details |
History of Severe Mental Illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Program Reach: Enrolment rate, Recruitment rate, Participation rate & Retention rate
Program Implementation: PLH-Facilitator Assessment Tool (PLH-FAT)
Externalizing behaviour problems in children: Child Behavior Checklist (CBCL) Parent form
Emotional problems in children: Child Behavior Checklist (CBCL) Parent form
Psychological distress in parents: Depression, Anxiety, Stress Scales (DASS)
Parental well-being: WHO-5 Well-Being Scale (WHO-5)
Dysfunctional parenting :The Parenting Scale (PS)
Positive parenting and effective discipline : Parenting of Young Children Scale (PARYC) |
pre intervention assessment one week before the intervention starts and post intervention assessment one week after the intervention is completed. The intervention will be for 4 to 10 sessions, weekly one session. The exact duration of the intervention will be confirmed after the adaptation phase is completed and findings from the pilot test. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="440"
Sample Size from India="440"
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)
|
01/09/2025 |
| 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="5"
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
|
Title : Parenting for Lifelong Health: Adaptation & Feasibility study of a Parenting Program for Primary Caregivers of Young Children
Aim: To adapt and assess the feasibility of a culturally appropriate version of the "Parenting for Lifelong Health" (PLH) program for primary caregivers of young children in India.
Objectives: 1)To identify the needs of parents, primary caregivers, and community health workers in accessing and delivering parenting services aimed at violence prevention and promoting positive parenting behaviours. 2)To tailor the PLH 4-9 program format and materials to align with the cultural context and public health service capacity in India 3)To enhance the knowledge and skills of Community Health Workers in delivering the program 4)To evaluate the adapted program in community settings in India, focusing on its acceptability, impact on parenting behaviours, and feasibility
Procedure:
Phase I: Program Adaptation The first phase includes a needs assessment using review of literature and consultation with stakeholders (including primary caregivers, health professionals, and child mental health experts) through interviews and group discussions. After analyzing the findings from the needs assessment the the PLH- YC will be modified program to better match Indian context. The program materials, session formats, and facilitator manuals will be culturally adapted. The CHWs willing to volunteer to under go training will be trained by the researcher to conduct the session with primary caregivers weekly once. A pilot test will then be conducted with trained CHWs (n=4) delivering the program to a group of primary caregivers (n= 40), to assess how well the adapted version is received.
Phase II: Program Implementation In the second phase, interested CHWs (n=40) will be selected and trained by the researcher. Interested Primary caregivers (n= 400) will be identified from the community as per the study criteria. CHWs will deliver the parenting program to these caregivers over four to ten weeks (The exact number of session will be finalized based on the adaptation and pilot test findings). Data will be collected before and after the intervention to evaluate its impact and feasibility. |