| 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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- 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)
- 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.
- 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: - Parental teaching behavior through video recording of mother-child interaction sequences while performing standardised tasks.
- Early child developmental outcomes using INTER-NDA Scores for cognition, language, fine motor, gross motor, positive and negative behavior
- Associations between parental teaching behavior and early cognitive outcomes in mother-child dyads from a western industrialized urban and rural study sites.
- 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: - Mothers with children between the ages of 24 to 30 months.
- Mother’s aged more than or equal to 18 years and who understand and speak Kannada language
- Mothers who will voluntarily consent to be included in the study
Exclusion criteria: - Mothers or children with developmental or mental health disorders
- Mothers aged less than 18 years of age
- Mothers not willing to provide consent
- 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. |