Plain English Summary
Background and study aims
Research on brain development suggests that experiences during the first three years of life have a major impact on child’s future. Play, touch, talk and respond in a loving manner will make a significant difference in the growth and development. Children learn while they play. Playing and learning are interconnected. This project proposes to empower parents and care givers in rural communities, by providing information on all aspects of child development such as physical including health and nutrition, mental (cognitive) development, language and communication, making friendly relationships with adults, other children and also the environment and nurturing children’s sense of self. The intervention is based on Learning Through Play (LTP) adapted versions of LTP developed by Bala Mandir Research Foundation (BMRF) and the Network for Information on Parenting with support from UNICEF. LTP focuses on domains of development such as Sense of self, Physical growth, Relationships, Understanding and Communications.
Nearly all early childhood development programs follow traditional theoretical training methods. The project designs the animated videos on parenting in the first 9 months of the project period and will be field tested for its effectiveness in parents’/caregivers’ knowledge, skills and behaviour in child rearing. It aims to demonstrate if the initiative has a positive & measureable influence on physical, cognitive, language and socio-emotional development of children through a specially designed tool.
Who can participate?
Primary and secondary caregivers of children aged between 18 and 24 months
What does the study involve?
Primary and secondary caregivers are randomized by village to one of two groups. Those in group A receive the video childhood development program, which includes parenting, health and nutrition, through learning to play. Those in group B form the control group and receive non-video based parenting and early childhood development.
Participants receive a series of questionnaires and assessments at baseline (before the program) and at endline (after the program).
What are the possible benefits and risks of participating?
The participants in this study are exposed to the parenting techniques during early childhood development, which may potentially bring in change in knowledge, attitude and practice in age appropriate stimulations during pregnancy and early child hood (first thousand days). There are no incentives in kind or money. The risk of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in this study is minimal or close to nil.
Where is the study run from?
Society for People's Education and Economic Change (SPEECH) (India)
When is the study starting and how long is it expected to run for?
January 2018 to June 2019
Who is funding the study?
Grand Challenges (Canada)
Who is the main contact?
Mr Arunodhayam Erskine (Public)
Trial website
Contact information
Type
Public
Primary contact
Mr Newton Ponnamuthan
ORCID ID
Contact details
Society for People's Education and Economic Change (SPEECH)
2/1060
Manoranjitham Street
Ezhilnagar
Tirupalai
Madurai
625014
India
+91 9842144699
mduspeech@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
R-SB-POC-1707-09378 (Grand Challenges Canada, Grant Number)
Study information
Scientific title
Animated videos on parenting for early brain development – A pilot project in India
Acronym
Study hypothesis
Animated videos on early childhood development and parenting are more effective compared to the regular theory based intervention
Ethics approval
Sigma - IRB, Sigma Research and Consulting Private Limited, 06/12/2017, ref: 10039/IRB/D/17-18
Study design
Interventional Study Design
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Community
Trial type
Quality of life
Patient information sheet
No participant information sheet available.
Condition
Child development
Intervention
The study proposes experimental study design. The project assesses the prevailing knowledge and practices through baseline and at the end of the project an endline is planned to assess the impact in terms of ante natal and pre-natal care, brain development, importance of psychological wellbeing and child development. The survey is supplemented with focus group discussions conducted with equal number of fathers and mothers to provide qualitative data and case studies to capture specific changes in practice.
Baseline: To assess the first 1000 days’ development / parenting skills a knowledge attitude and practice (KAP) survey and a standardised growth and development monitoring checklist (NDDS) is administered. Nippising District Development Screen (NDDS) checklist is a standardised tool filled in by the parents to measure the emotional, fine motor, gross motor, learning and thinking, self-help, communication, vision and hearing of children belonging to the age group 0 and 24 months.
For the purpose of the study, we presumed that each child or pregnant woman has at least two primary caregivers and one secondary caregiver. Based on the estimation of three caregivers per child and per pregnant woman, total number of caregivers from all 53 villages is estimated as 3126. The sampling unit for this study is the primary and secondary caregivers of children between 18 and 24 months of age. For the baseline the sample unit of caregivers of children between 18 and 24 months is selected as they have already passed through the stages of pregnancy till the 18 months to 24 months which will make the first 1000 days of life. The total sample estimated as 423.
Treatment and Control Group: Once the baseline is complete the villages are randomly divided as Group A and Group B.
Group A (treatment group, 42 villages, n=2418) parents are exposed to animated videos on parenting and early childhood development that show ante natal and pre-natal practices, parenting for holistic development of children in the first 1000 days of life, age appropriate stimulation techniques to enhance brain development and parenting messages on nutrition, health and safety. The intervention is based on Learning Through Play (LTP) adapted versions of LTPC developed by Bala Mandir Research Foundation (BMRF) and the Network for Information on Parenting with support from UNICEF. LTPC focuses on the following domains of development
- Sense of self
- Physical growth
- Relationships
- Understanding
- Communications
It takes advantage of the technological advancements such as mobile phone, tablets, laptops and video players. Additionally, short video clips can be viewed repeatedly, shared and enable a larger dialogue on holistic parenting practices in the community. Facilitators selected from local area will be trained to supplement these videos with relevant information to ensure people’s participation.
Group B (control group, 11 villages, n=729) are exposed to non-video based parenting and early childhood development. The homogeneity of Group A and Group is ensured by means of randomly selecting the parents from same Taluk and similar socio economic characteristics. To control spill-over effect, both the groups are selected from villages of different panchayats but from the same Taluk.
Endline: To measure the knowledge gain, a knowledge attitude and practice (KAP) survey and a standardised growth and development monitoring checklist is administered again with the treatment and control group. The results are compared against baseline and endline; and the hypothesis is tested using standard statistical tests between the two groups’ treatment and control. The caregivers identified (2nd and 3rd trimester pregnant women and the caregivers) at the beginning of the intervention are the sample for the endline as they are going through most of the intervention stages during the proposed time period. It is estimated that for the endline the sample size is 597.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Knowledge, attitude and practice on parenting is assessed using a survey at baseline and endline.
2. Anthropometric measures, growth and development is measured using the Nippising District Development Screen (NDDS) scale at baseline and endline.
3. Age appropriate stimulations given by parents are reported by parents at baseline and endline.
Secondary outcome measures
Changes in parenting are assessed using survey questionnaire at baseline and endline.
Overall trial start date
01/01/2018
Overall trial end date
30/06/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Primary care givers (both father and mother) of children between 18 and 24 months
2. Secondary care giver (one) of children between 18 and 24 months
Participant type
Other
Age group
Adult
Gender
Both
Target number of participants
Experiment Group - 2418 (parents and caregivers) from 42 villages; Control Group - 729 (parents and caregivers) from 11 villages
Participant exclusion criteria
Parents and caregivers of children above the age of 24 months
Recruitment start date
01/04/2018
Recruitment end date
30/06/2018
Locations
Countries of recruitment
India
Trial participating centre
Society for People's Education and Economic Change (SPEECH)
Society for Peoples Education and Economic Change
2/1060, Manoranjitham Street
Ezhilnagar, Tirupalai,
Tamilnadu
Maduri
625014
India
Sponsor information
Organisation
Grand Challenges Canada
Sponsor details
MaRS Centre
West Tower
661University Avenue
Suite 1720
Toronto
Ontario
M5G 1M1
Canada
+14165835821
info@grandchallenges.ca
Sponsor type
Other
Website
Funders
Funder type
Government
Funder name
Grand Challenges Canada
Alternative name(s)
Grands Défis Canada
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Canada
Results and Publications
Publication and dissemination plan
As per our funding agreement with Grand Challenges Canada, all research related outputs must be shared with Grand Challenges Canada and its community researchers and related institutions and must be disseminated as quickly and broadly as possible to the scientific community. We expect to complete the research by the end of June 2019 and publish the report in renowned peer reviewed journal within a period of 6 months after the research.
IPD sharing statement:
As per the agreement with the Grand Challenges Canada Data Access policy, data from funded projects will be made openly accessible to the Grand Challenges Canada Research Community through ethical and efficient data access practices. We will be consulting with Registry of Research Data Repositories (http://www.re3data.org) and similar catalogues to identify suitable repositories. The data will be openly accessible within 6 months of completion of the research. After removing the identifiers, the response of respondents collected through the surveys, NDDS checklist will be made available for the scientific community. We will ensure that the relevant aspects of research will be conducive for data access. We will obtain permissions to share data from the respondents through informed consent and also in the ethics approval documents.
Intention to publish date
31/12/2019
Participant level data
Stored in repository
Basic results (scientific)
Publication list