Condition category
Not Applicable
Date applied
13/10/2014
Date assigned
28/10/2014
Last edited
01/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The first 5 years of a child’s life are very important. It is a time of dramatic brain growth and development. However, this vital time of development can be badly affected by malnutrition, illness and living in an unstimulating home environment. There is evidence to suggest that interventions in early childhood can have a significant effect on children’s development. Our focus is rural and semi-urban Colombia where the development of children lag behind their urban counterparts, and where the quality of early childhood services is poor and inadequate. In 2011, the government launched a national early childhood strategy “From Birth to 5/Forever” with the aim to improve childcare services provided to approximately 1.2 million children. However, the strategy has a lower capacity in rural and semi-rural areas than in urban areas. This project will design, implement and evaluate improvements to the curriculum used in the existing early childhood services in rural and semi-urban areas, the Hogares Fami (FAMI). FAMI are family-based parenting services for pregnant women and children below 24-30 months. The aim is to improve child development by improving parenting practices.

Who can participate?
Children aged between 0-12 months of age and their mothers, and also pregnant women who are attending FAMIs in towns in rural and semi-urban Colombia. FAMI is a programme working with women and children offering support on, for example, self-care during pregnancy and parental skills.

What does the study involve?
Each town is randomly allocated to either the treatment or the control group. FAMIs in control towns operate as usual. Treatment towns operate new enhanced FAMIs where all the participants in that town follow a structured psychosocial stimulation curriculum for 18 months, promoting child development though play, language activities, and improved parenting. Since February 2015, the intervention also includes a food basket, which is delivered monthly through the FAMI mothers (added 01/12/2015). Data is collected before the study begins and when it ends.

What are the possible benefits and risks of participating?
We do not foresee any risks for study participants.

Where is the study run from?
The study is run from Bogota and Medellin, in Colombia, and from London, UK.

When is the study starting and how long is it expected to run for?
September 2014 to April 2016

Who is funding the study?
1. Grand Challenges (Canada)
2. Success Foundation (Fundación Éxito) (Colombia)

Who is the main contact?
Professor Raquel Bernal Salazar

Trial website

Contact information

Type

Scientific

Primary contact

Prof Raquel Bernal Salazar

ORCID ID

Contact details

Universidad de los Andes
Calle 1 # 18A - 12
Bogota
N/A
Colombia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

An integrated ECD intervention targeted at deprived young children in Colombia: an RCT evaluation

Acronym

Study hypothesis

Promote child development through improved parenting practices for children 0-30 months of age attending family-based parenting services, FAMI, in rural and semi-urban areas of Colombia.

Ethics approval

Committee on Research Ethics, University of Los Andes, 08/05/2014, ref. 287 de 2014
UCL Research Ethics Committee, 16/07/2014, ref. 2168/011

Study design

2 arm cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Early childhood development (ECD); psychosocial stimulation

Intervention

Community-based intervention to promote early childhood development in family-based parenting services. 96 clusters in total.
1. Treatment group: enhanced FAMI through psychosocial stimulation and nutrition curriculum. FAMIs in 49 clusters will receive an enhanced FAMI intervention where all children (0-24 months) attending FAMI, their mothers, and pregnant women in the FAMI will follow a structured psychosocial stimulation curriculum, focused on the promotion of child development through play, language activities, and messages on child stimulation and parenting. The curriculum will also include best nutritional practices. This curriculum will be delivered by (current/existing) FAMI mothers in weekly group sessions and monthly home visits—following the standard modus operandi at regular FAMIs—for 18 months. Since February 2015, the intervention will also include a food basket (delivered monthly through the FAMI mothers) (added 01/12/2015). Note that we will only evaluate children 0-12 months old in the FAMI, and their mothers, and pregnant women.
2. (Active) Control group: regular FAMI
Pregnant women, and children and their mothers in 47 clusters will receive the standard FAMI program, as is currently operating in these areas.

Total duration of intervention: 18 months (2 periods of 3 months of data collection will precede and follow the intervention)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

At follow up:
1. Children's cognitive, language, motor and socio-emotional development (possibly using the ASQ test, the MacArthur-Bates Child Development Inventories, and/or the Bayley-III)
2. Height and weight (added 24/11/2015)

At baseline we will collect height, weight, and WHO motor milestones (the latter, for children 6-12 months only).

Secondary outcome measures

1. Parenting practices and the level of stimulation in the home, possibly using the Family Care Indicators (FCI)
2. Activities developed by FAMI providers and knowledge of FAMI mothers on child rearing and development

Overall trial start date

01/09/2014

Overall trial end date

30/04/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children aged 0-12 months of age at baseline, attending FAMIs in 96 towns in rural and semi urban Colombia, by random assignment within the FAMI (preference will be given to children 0-6 months so that the can benefit from the intervention longer)
2. Pregnant women at baseline in the same FAMIs, by random assignment within the FAMI
3. Informed consent

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

2,000 children in 96 clusters 1,200 pregnant women in 96 clusters

Participant exclusion criteria

1. Children outside the 0-12 months of age range at baseline attending selected FAMIs (these children will be excluded from the study but will receive the intervention)
2. Children and pregnant women not attending selected FAMIs

Recruitment start date

01/09/2014

Recruitment end date

30/04/2016

Locations

Countries of recruitment

Colombia

Trial participating centre

Universidad de los Andes, Calle 1 # 18A - 12
Bogota
N/A
Colombia

Sponsor information

Organisation

Grand Challenges Canada (Canada)

Sponsor details

MaRS Centre
South Tower
101 College Street
Suite 406
Toronto
M5G 1L7
Canada

Sponsor type

Government

Website

Funders

Funder type

Other

Funder name

Grand Challenges (Canada) -- 0642-03-10

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Success Foundation (Fundación Éxito) (Colombia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes