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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

01 Apr 2019

The date of last modification

Apr 03, 2019



Application Summary


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


Trial Details


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.

  1. Masking will only be applied to assessors at baseline. The providers, participants and data analysts will not be masked.

Inclusion criteria

  1. Resident in the last year in the selected areas and provide consent to take part in the trial;
  2. Have a child 6 to 24 months as of 1st January 2019. The younger of two children will be selected.
  3. Has agreed for home visits by facilitators and will visit the intervention sites (community centers) during intervention.

Exclusion criteria

  1. Children who have documented or examined to have significant illness or disability that will not allow age appropriate interventions to be provided (e.g. children with severe development delays, disabilities such as cerebral palsy)
  2. Children who do not have a permanent carer (mother/father/grandparents) for the planned period of one year.
  3. Mother is pregnant.
  4. Mother/primary caregiver with mental disability (e.g. severe depression, Schizophrenia)


Primary outcome(s)

1.
  1. Child anthropometric measurements – height/length and weight at baseline and endline (after 6 months) to derive anthropometric indices (weight-for-age, weight-height and height-for-age) using instruments (Seca brand), with the support of trained data collectors; WHO Anthro software will be used to compute standard z-scores of weight for age, height for age and weight for height versus WHO 2007 reference population

2.Child age-appropriate development of language, cognitive, social-emotional and motor development

  • Caregiver reported early childhood development Instrument (CREDI) to measure child age-appropriate development for language, cognitive, social-emotional and motor development.

  • Bayley-III, screening of child development in four domains (language, cognitive, social-emotional and motor), will be applied to a nested sample of children from control and intervention sites, by trained psychometricians or paediatricians.

[

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


Date of study completion


Recruitment status

Pending


Funding source

World Vision Lanka and World Vision International


Regulatory approvals

Ministry of Health, Sri Lanka



State of Ethics Review Approval


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 & Sponsor Information


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

Secondary study sponsor (If any)







Trial Completion details


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



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