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CTRI Number  CTRI/2024/07/070149 [Registered on: 08/07/2024] Trial Registered Prospectively
Last Modified On: 29/12/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Effect of parent teaching style on child development 
Scientific Title of Study   The Effect of Parenting Styles on Cognitive Development in Early Childhood. A Cross-cultural study. MATCHI (maternal interaction, culture & child) 
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 S M Dhaded 
Designation  Professor of Neonatology 
Affiliation  J N Medical College KAHER Belagavi 
Address  Department of Neonatology J N Medical College Nehru Nagar Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9844232586  
Fax  918312472891  
Email  drdhadedsm@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr S M Dhaded 
Designation  Professor of Neonatology 
Affiliation  J N Medical College KAHER Belagavi 
Address  Department of Neonatology J N Medical College Nehru Nagar Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9844232586  
Fax  918312472891  
Email  drdhadedsm@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Deepa Metgud 
Designation  Professor of Paediatric Physiotherapy 
Affiliation  KLE Institute of Physiotherapy 
Address  Department of Paediatric Physiotherapy KLE Institute of Physiotherapy JNMC campus KAHER Nehru Nagar Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  8088246710  
Fax    
Email  drdeepa_metgud@yahoo.com  
 
Source of Monetary or Material Support  
University of Regensburg, Sedanstr. 1, PIN Code: 93053 Regensburg, Germany 
 
Primary Sponsor  
Name  University of Regensburg 
Address  University of Regensburg, Sedanstr. 1, PIN Code: 93053 Regensburg, Germany 
Type of Sponsor  Other [Private University] 
 
Details of Secondary Sponsor  
Name  Address 
BAYIND Fellowship  The Bavarian-Indian Centre for Business and University Cooperation (BayIND) Funded by Bavarian State Ministry of Science and the ArtsAlfons-Goppel-Platz 1 95028 Hof, Germany 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr S M Dhaded   KLES Hospital and Medical Research Centre  Department of Paediatrics, Ground floor, OPD No 8, JN Medical College KLE Academy of Higher Education and Research Nehru Nagar Belagavi
Belgaum
KARNATAKA 
9844232586

drdhadedsm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of KLE Academy of Higher Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Mothers aged more than or equal to 18 years with children between the ages of 24 to 30 months 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  None 
Comparator Agent  NIL  None 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  1 Mothers with children between the ages of 24 to 30 months
2 Mothers aged more than or equal to 18 years who understand and speak Kannada language
3 Mothers who will voluntarily consent to be included in the study 
 
ExclusionCriteria 
Details  1 Mothers or children with developmental or mental health disorders
2 Mothers aged less than 18 years of age
3 Mothers not willing to provide consent
4 Any other condition as per investigator’s decision
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Parental teaching behavior  Baseline (at the time of evaluation) 
 
Secondary Outcome  
Outcome  TimePoints 
Early child development  Baseline (at the time of evaluation) 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/08/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  By email communication to Dr S M Dhaded (drdhadedsm@gmail.com) and Dr Deepa Metgud (drdeepa_metgud@yahoo.com)

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Background

The early years of life represent a crucial period marked by heightened sensitivity to environmental stimuli and intense learning. Central to this process are early social interactions and the transmission of cultural knowledge across generations. While prior research has established significant variations in parental teaching behaviour across cultures, its impact on children’s socio-cognitive development remains understudied, particularly in low- and middle-income countries. In this study, we investigate cross-cultural differences in parental teaching and early child development across urban and rural contexts in India, Nigeria, Germany, Brazil, and Japan. By exploring diverse cultural settings, we aim to shed light on the critical role of parental teaching in shaping early cognitive development and extending our understanding beyond simplistic dichotomies. This research contributes to a deeper comprehension of the environmental factors influencing early child development and underscores the importance of culturally sensitive approaches in studying parental behaviour and child developmental outcomes.

Aim

The present cross-cultural study aims to examine:

  1. Parental teaching behavior through video recording of mother-child interaction sequences while performing standardised tasks.
  2. Early child developmental outcomes using INTER-NDA Scores for cognition, language, fine motor, gross motor, positive and negative behavior
  3. Associations between parental teaching behavior and early cognitive outcomes in mother-child dyads from a western industrialized urban and rural study sites.
  4. Association of maternal variables, such as maternal history of childhood maltreatment and postnatal depression with maternal parental teaching and early child development

Study design and Eligibility Criteria

This will be a Cross Cultural, Cross- sectional study

Inclusion criteria:

  1. Mothers with children between the ages of 24 to 30 months.
  2. Mother’s aged more than or equal to 18 years and who understand and speak Kannada language
  3. Mothers who will voluntarily consent to be included in the study

Exclusion criteria:

  1. Mothers or children with developmental or mental health disorders
  2. Mothers aged less than 18 years of age
  3. Mothers not willing to provide consent
  4. Any other condition as per investigator’s decision

Enrolment of Subjects

All participants who fulfil the eligibility criteria will be enrolled into the study after obtaining informed consent. Since the current study is focussing on early child development in general, a special screening is not required. We will enrol around 70 urban families from urban health centers and 30 rural families from primary health centres for participation in the study.

Study Procedures

In case parents agree with the participation together with their children, they are required to visit the central facility for scheduled assessments. The data collection during the study will be performed by the members of the study group. After taking consent the BESOZ tool will be used to assess mother-child-interaction patterns and INTER NDA for testing early child development.

BESOZ:

BESOZ is a recently developed tool that has been culturally adjusted and validated in recent cross-cultural research in nine urban and rural samples Para (Brazil), near Cotacatchi (Peru), as well as urban samples from Buenos Aires (Argentina), Münster (Germany), Kabale (Uganda), Ibadan (Nigeria), Regensburg (Germany), Bergen (Norway) and Kyoto (Japan).

Each mother-child dyad completes thirteen standardized tasks in cooperation (e.g., building a tower out of bricks), problem-solving (e.g., a simple puzzle), task assignment (e.g., bringing over objects), and innovation (e.g., generating ideas about unknown objects and shapes). These materials have demonstrated reliability and consistency in previous studies conducted in both high- and low-income countries (Köster et al., 2016, in preparation).

INTER-NDA:

The INTER-NDA (www.inter-nda.com) is a rapid and comprehensive assessment tool that measures the cognitive, motor, language, positive and negative behavioral skills of children aged 22-30 months (Fernandes et al 2014, 2020). It consists of 37 items and uses a combination of psychometric techniques to minimize bias in caregiver interviews and to account for the differences in performance between artificial testing environments and familiar settings (Fernandes et al 2014, 2020).

Study Outcomes

  • Parental teaching behaviour of mother
  • Early child development

Sample Size

We aim for a final sample size of 90 children (60 urban, 30 rural). Thus, we will invite around 100 families to participate in the study, considering around 10 for piloting purposes. Based on prior research we estimate 90 participants will be adequate sample size for India, because this will also allow us to investigate within cultural variation in parental behavior and associations with child development.

Study timeline

The total study duration will be 12 months. Initial 6 months for site preparation, in- country regulatory approvals and training. Recruitment and data collection will occur approximately over a period of 4 months. The last 2 months will be utilised for data cleaning and analysis.

 
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