Condition category
Not Applicable
Date applied
13/10/2014
Date assigned
28/10/2014
Last edited
28/04/2017
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 about 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. The intervention also includes a food basket, which is delivered monthly through the FAMI mothers. Data is collected before the study begins and when it ends.

What are the possible benefits and risks of participating?
No risks are foreseen for study participants.

Where is the study run from?
The study is run from Bogota and Medellin (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?
Prof. Raquel Bernal Salazar

Trial website

Contact information

Type

Scientific

Primary contact

Prof Raquel Bernal Salazar

ORCID ID

http://orcid.org/0000-0001-9980-7303

Contact details

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

Type

Scientific

Additional contact

Dr Marta Rubio-Codina

ORCID ID

Contact details

3rd Floor
7 Ridgmount Street
London
WC1E 7AE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

An integrated Early Childhood Development intervention targeted at deprived young children in Colombia: a randomised controlled trial 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

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

Study design

Two-arm cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details 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

Current primary outcome measures as of 18/04/2017:
1. Children's cognitive, receptive and expressive language and motor development, measured using the Bayley-III at follow-up (April-July 2016)
2. Children's socio emotional development, measured by ASQ test at follow-up (April-July 2016)
3. Children's height and weight, measured by assistant nurses in local community centers at baseline (August-November 2014) and follow-up (April-July 2016)
4. WHO motor milestones (the latter for children 6-12 months only), measured at baseline (August-November 2014)

Previous primary outcome measures:
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), measured at follow up
2. Height and weight, measured at baseline and follow up (added 24/11/2015)
3. WHO motor milestones (the latter for children 6-12 months only), measured at baseline

Secondary outcome measures

Current secondary outcome measures as of 18/04/2017:
Measured at baseline (August-November 2014) and follow-up (April-July 2016):
1. Parenting practices and the level of stimulation in the home, measured using UNICEF’s Family Care Indicators (FCI)
1.1. No. of toy sources
1.2. No. of varieties of play materials
1.3. No. of varieties of play activities over past 3 days
1.4. No. of parental care activities over past 3 days
2. Use of verbal or physical abuse in the household, measured using UNICEF’s FCI
3. Parent knowledge about early childhood development, measured using a 10-item scale based on KIDI
4. Maternal self-efficacy, measured using the Caregiver Role Test – Modified
5. Mothers with depression symptoms, measured using Center for Epidemiologic Studies Depression Scale (CESD-10)
6. Maternal social support, measured using the DUKE UNC-11 scale
7. Variables of FAMI providers: activities developed in group sessions, collected through videos that are coded

Previous 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

01/02/2014

Overall trial end date

01/07/2016

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

Mixed

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

31/03/2016

Locations

Countries of recruitment

Colombia

Trial participating centre

Universidad de los Andes
Bogota
N/A
Colombia

Trial participating centre

Institute for Fiscal Studies
7 Ridgemount Street Bloomsbury
London
WC1E 7AE
United Kingdom

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)

Grands Défis Canada

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Canada

Funder name

Success Foundation (Fundación Éxito) (Colombia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal in first quarter 2018.

IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Raquel Bernal.

Intention to publish date

31/03/2018

Participant level data

Available on request

Results - basic reporting

See additional file ISRCTN93757590_BasicResults_07Apr17.docx

Publication summary

Publication citations

Additional files

Editorial Notes

28/04/2017: The basic results of this trial have been uploaded as an additional file. 20/04/2017: The following changes were made to the trial record: 1. The overall trial start date was changed from 01/09/2014 to 01/02/2014. 2. The overall trial end date was changed from 30/04/2016 to 01/07/2016.