Home » Trials » SLCTR/2019/014
Evaluation of "GO BABY GO" child development programme among vulnerable groups in Sri Lanka - A pragmatic cluster randomised trial
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SLCTR Registration Number
SLCTR/2019/014
Date of Registration
The date of last modification
Oct 18, 2021
Trial Status
Scientific Title of Trial
Evaluation of "GO BABY GO" child development programme among vulnerable groups in Sri Lanka - A pragmatic cluster randomised trial
Public Title of Trial
Effects of an integrated early childhood parenting programme on child development and growth of children 6-24 months in Sri Lanka: a pragmatic cluster randomized trial.
Disease or Health Condition(s) Studied
Child Development
Scientific Acronym
GO BABY GO = GBG
Public Acronym
GBG
Brief title
Parental intervention program to optimize early childhood development
Universal Trial Number
U111-1229-0472
Any other number(s) assigned to the trial and issuing authority
ERC Kelaniya Ref. P/07/01/2019
What is the research question being addressed?
Do children of mothers/primary caregivers who are provided the GBG integrated intervention and World Vision Lanka CH &N programme, exhibit,
a) better age appropriate child developmental outcomes, b) improved nutrition status than controls provided with the World Vision Lanka CH &N programme only.
and
Do mothers/primary caregivers who are provided the GBG integrated intervention and World Vision Lanka CH &N programme, exhibit higher levels of responsive parenting skills of their under three age group children, than controls provided with the World Vision Lanka CH &N programme only
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded : Outcome assessors
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Supportive care
Study Phase
Not Available
Intervention(s) planned
Study setting: Participants of the study will be drawn from three Area programmes (AP) of World Vision Lanka. They are Ridigama AP in the Kurunegala district of North Western province, Chankanei AP in Jaffna district of Northern Province, and Karachchi AP, Kilinochchi district of Northern Province. Both control and intervention arms will be located in all three APs.
Randomization: Randomization will be based on GN areas. From each area, there will be 5 intervention and 5 control areas.
Intervention: The intervention arm will consist of the “Go Baby Go” intervention and The Child Health and Nutrition Package (CH&N) developed based on the guidelines of the Ministry of Health , delivered by World Vision Lanka under the supervision of the Medical Officer of Health.
Go Baby Go: The Go Baby Go! (GBG) parenting programme is developed to strengthen the confidence and competence of mothers (starting in pregnancy), fathers, and other primary caregivers of children 0 to 3 years old, thereby, promoting caregiver-child relationships that foster children’s growth, learning and lifelong development. GBG’s ultimate goal is to empower parents and caregivers with the skills to create positive change within their families, to foster holistic, early childhood development (ECD) in practical ways, and establish the strongest foundation possible for their children’s futures. The Go Baby Go intervention will comprise 10-12 group sessions (each about 45 to 90 minutes) involving approximately 30 caregivers, conducted every 2 weeks over the 6-month intervention period. This will be further supported by approximately 3-4 home visits every month during the first 3-4 months of the intervention. The group sessions will cover areas such as holistic child development, nurturing development in domains such as cognitive, language, physical and socio emotional, play and communication, home environment, family affairs and community action planning.
Child Health & Nutrition intervention Package:
• The Infant and Young Child feeding (IYCF) guidelines prepared by the Family Health Bureau of the Ministry of Healthcare, Nutrition and Indigenous Medicine will be used in WVL community level programmes collaborating with the Medical Officers of Health in order to ensure uniformity in the messages given. WVL staff organizing the community level programmes will use the support of the mother support groups’ members in using the IYCF guidelines (MOH, 2014). There will be three sessions including a food/cooking demonstration as well.
• Water, Sanitation and Hygiene (WASH) Programme : For prevention from diseases component, the project will focus on the following diseases: ARI, Dengue, Fever, Diarrhea, and other water borne diseases that are important to areas of implementation. There will be two sessions for Water, Sanitation and Hygiene and disease prevention in addition to the IYCF programme.
Control: Standard therapy: the standard therapy will consist of the Child Health and Nutrition Package which include the Infant and Young Child feeding (IYCF) and the Water, Sanitation and Hygiene (WASH) Programme, developed based on the guidelines of the Ministry of Health , delivered by World Vision Lanka under the supervision of the Medical Officer of Health.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
1.
2.Child age-appropriate development of language, cognitive, social-emotional and motor development
|
[ Base line and after 6 months ] |
Secondary outcome(s)
1.
None |
[ None ] |
Target number/sample size
660
Countries of recruitment
Sri Lanka
Anticipated start date
2019-04-01
Anticipated end date
2019-12-31
Date of first enrollment
2019-05-13
Date of study completion
Recruitment status
Complete: follow up continuing
Funding source
World Vision Lanka and World Vision International
Regulatory approvals
Ministry of Health, Sri Lanka
Status
Approved
Date of Approval
2019-01-07
Approval number
P/07/01/2019
Details of Ethics Review Committee
Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
Institutional Address: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
Telephone: | 011-2961267 |
Email: | ercmed@kln.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Prof. Rajitha Wickremasinghe
Professor of Public Health
Department of Public Health,
Faculty of Medicine,
University of Kelaniya
0112953411 / 0112961140 / Ext. 140
0777678591
0112953411
rajwicks@gmail.com
http://medicine.kln.ac.lk/depts/publichealth/staff/academic-staff.html
Contact Person for Public Queries
Amandhi Caldera
Research assistant
Department of Public Health,
Faculty of Medicine,
University of Kelaniya
0112953411 / 0112961140 / Ext. 140
0779821429
amandhicaldera@gmail.com
Primary study sponsor/organization
Work Vision International and World Vision Lanka
NGO
No.619/8, Dr. Danister De Silva Mawatha, Colombo 09. Sri Lanka.
+94 11 2691233 / 2691234 / 2687980
+94 11 2697577
srilanka@wvi.org
https://www.wvi.org/srilanka
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
Yes
Protocol version and date
28.01.2019 Version 2
Protocol URL
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results