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CTRI Number  CTRI/2026/03/105721 [Registered on: 09/03/2026] Trial Registered Prospectively
Last Modified On: 03/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Parent Teaching program on behavioral problems]  
Study Design  Other 
Public Title of Study   Effect Of Training Program On Stress Wellbeing Coping Mechanisms And Family Impact Of Mothers Having Children With Behavioral Problems  
Scientific Title of Study   Effectiveness Of Parent Teaching Program (PTP) On Parenting Stress Quality Of Life Coping Strategies And Family Impact Of Mothers Of Children With Behavioral Problems Hospital Based Study West Bengal India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arpita Bandyopadhyay 
Designation  Reader 
Affiliation  GCON BSMC Bankura West Bengal 
Address  GCON Bankura Sammilani Medical College Bankura West Bengal India Building Govt. College of Nursing Department Child Health Nursing 2nd Floor Room No 307 Ph 9830132109

Bankura
WEST BENGAL
722102
India 
Phone  09830132109  
Fax    
Email  iiarpita.bandyopadhyay.ab@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mamatha Shivananda Pai 
Designation  Professor 
Affiliation  MCON ,MAHE Manipal Karnataka 
Address  MCON MAHE Manipal Karnataka India Dr Mamatha Shivananda Pai Designation Professor Manipal College of Nursing Manipal Academy of Higher Education Manipal Karnataka Building Manipal College of Nursing Department Child Health Nursing 1st Floor MCON Building Room No : Faculty Name Plate available 1st floor opposite and right side of the lift End room Ph 944 8623789

Udupi
KARNATAKA
576104
India 
Phone  9448623789  
Fax    
Email  mamatha.spai@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Mamatha Shivananda Pai 
Designation  Professor 
Affiliation  MCON ,MAHE Manipal Karnataka 
Address  Dr Mamatha Shivananda Pai Designation Professor Manipal College of Nursing Manipal Academy of Higher Education Manipal Karnataka Building Manipal College of Nursing Department Child Health Nursing 1st Floor MCON Building Room No : Faculty Name Plate available 1st floor opposite and right side of the lift End room Ph 944 8623789

Udupi
KARNATAKA
576104
India 
Phone  9448623789  
Fax    
Email  mamatha.spai@manipal.edu  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Arpita Bandyopadhyay 
Address  Arpita Bandyopadhyay Designation Reader Govt. College of Nursing Bankura Sammilani Medical College Bankura West Bengal PIN 722102 Building Govt. College of Nursing Department Child Health Nursing 2nd Floor Room No 307 Ph 9830132109  
Type of Sponsor  Other [(Individual) Arpita Bandyopadhyay Primary Investigator] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Arpita Bandyopadhyay  NRS MC&H Kolkata West Bengal  Psychiatry OPD 3rd Floor of OPD Building NRS MCH Kolkata Room Seminar Room Child Guidance clinic and Room number 301 Psychiatry IPD 3rd Floor of IPD Building Chest and Psychiatry Department Psychiatry ward Male Ward and Female Ward 138 AJC Bose Road Raja Bazar Sealdah Kolkata 700014 West Bengal India
Kolkata
WEST BENGAL 
09830132109

iiarpita.bandyopadhyay.ab@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee(EC/NEW/2023/1862)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Parent teaching program  Researcher made intervention to deal challenging behavior of child. Teaching should be administered in one to one sessions along with standard treatment  
Comparator Agent  Standard treatment  only standard treatment no researcher administered parent teaching program will be given 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  Mother of child diagnosed as ASD

Mother of child diagnosed as ADHD

Mother who is dealing with problem at least six months with their child

Mother who can read & understand Bengali or English

Mother of child within age group upto 16 years
 
 
ExclusionCriteria 
Details  Mother with known psychiatric disorders
Mother with auditory or other impairments
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Parenting Stress of mother  Phase 1 and Phase 2
Parenting stress  
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life
Family impact
Coping Strategies 
phase 2 of study
duration two months 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   16/03/2026 
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="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  
Problem Statement  Effectiveness  of Parent Teaching Program PTP on Parenting Stress Quality of Life Coping Strategies And Family impact of Mothers of Children with Behavioral Problems    Hospital Based Study West Bengal India
 
This study will be conducted in two  phases                      Phase 1 and Phase 2
Research approach                                               Quantitative Research Approach
                                 PHASE 1 Methodology

PHASE 1 OBJECTIVES
1 To assess the level of parenting stress of mothers of children with behavioral problems
2 To identify the factors for parenting stress of mothers of children with behavioral problems

Delimitation                  Study is delimited to the mother of children diagnosed with Attention Deficit Hyperactivity Disorder and Autism Spectrum       Disorder

Phase 1 Research Design                                Descriptive cross sectional survey design
Phase 1 Population                                           Mothers of Children with behavioral Problems
Phase 1 Sample                                                Mothers of Children with behavioral Problems attending Psychiatric OPD and IPD NRS MCH Kolkata West Bengal
Phase 1 Sample Size                                        N 200    To be recalculated after Pilot study
Phase 1 Sampling technique                            Mothers will be recruited from Psychiatric OPD and IPD NRS MCH Kolkata West Bengal India according to inclusion criteria by            purposive sampling technique
Phase 1 Setting                                               Psychiatric OPD and IPD NRS MCH Kolkata West Bengal India
Phase 1 Inclusion criteria                                 Mother of child diagnosed with ADHD
                                                                         Mother of child diagnosed with Autism Spectrum Disorder
                                                                         Mother who is dealing with behavioral problem at least 6 months
                                                                         Mother who is willing to participate in the study and will give written consent
                                                                         Mother who can read and understand Bengali or English
                                                                         Mother of child within age group up to 16 years 
Phase 1 Exclusion criteria                                Mother with known psychiatric disorder
                                                                          Mother with auditory or other impairments
Phase 1 Tool & Technique                                Tool    Semi Structured interview schedule  for demographic proforma & factors for parenting stress   Technique      Interviewing 
                                                                          Parental Stress Scale standardized tool            to assess level of parenting stress
                              
Phase 1 Data analysis                                       Frequency Percentage mean SD and chi square test

                                   PHASE 2 Methodology
 PHASE 2 OBJECTIVES              
1 To evaluate the effectiveness of Parent Teaching Program PTP in terms of 
                               Quality of Life of mothers of children with behavioral problems
                               Family Impact of mothers of children with behavioral problems
                               Coping Strategies of mothers of children with behavioral problems 
 
Phase 2 Research Design                                    Non equivalent Control Group Pre test Post Test Design
Phase 2 Population                                              Mothers of Children with behavioral Problems
Phase 2 Sample                                                   Mothers of Children with behavioral Problems attending Psychiatric OPD and IPD NRS MCH Kolkata West Bengal
                                                                             Selected from Phase 1 
                                                                             mothers with parenting stress more than 50th percentile will to be included in the phase 2 of study
Phase 2 Sample Size                                          60 in each group                that is in Experimental and Control Group
Phase 2 Sampling technique                               Mothers with parenting stress index more than 50th percentile
                                                                            To be selected from phase 1
                                                                            Simple random sampling method will be adopted to assign the mothers in two groups        Intervention & Control group
Phase 2 Setting                                                   Psychiatric OPD and IPD NRS MCH Kolkata West Bengal India for both Intervention & Control group

Phase 2 Inclusion criteria                                    Mothers who has participated in the phase 1 of study
                                                                            Mothers  with parenting stress score more than 50th percentile 
                                                                            Mother who is willing to participate in the Phase 2 of the study
                                                                            Mother who will give written consent 
                                                                            Mother who can read or understand Bengali or English
Phase 2 Exclusion criteria                                   Mother who is very sick at the Phase 2 of the study
Phase 2  Tool & Technique                                 WHO BREF QOL by WHO
                                                                           Family Impact Module By MAPI Trust  Phase 2 Standardize Tool
                                                                           BRIEF COPE INVENTORY  Standardize Tool
                                                                           Parental Stress Scale  Standardized Tool

Details about Intervention                               The intervention is a PTP that is Parent Teaching Program prepared by a Researcher to deal with challenging behavior of their  child with ADHD and                                                                                                            ASD 
                                                 It is computer assisted teaching program to be administered one to one face to face in two sessions Day 1 and Day 15 
                                                                        Total Duration of the program 4 hours in two sessions 
                                                                         Each session 2 hours approximately
                                                                        The intervention will be administered in the Phase 2 of the study to the mothers of he children with behavioral problems with  high stress score that is more than 50th                                                                               percentile
                                                                        Mother will get intervention along with standard treatment on Day 1    Day 15 of the study Phase 2
                                                                       Pre Test will be taken on Day 1 and Day 15 
                                                                       Post Test will be taken on Day 30 and Day 60
                               
                                                                      Control group will get only Standard treatment 
                                                                      Pretest will be taken on Day 1 and Day 15
                                                                      Post Test will be taken on Day 30 and Day 60

Phase 2 Data analysis                                  Descriptive and inferential statistics
                            
                               
 




                          
            

 
                                                    

                              

                              

 
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