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Using the infrastructure of a conditional cash transfer program to deliver a scalable integrated early child development program in Colombia: cluster randomized controlled trial
Last registered on March 02, 2016

Pre-Trial

Trial Information
General Information
Title
Using the infrastructure of a conditional cash transfer program to deliver a scalable integrated early child development program in Colombia: cluster randomized controlled trial
RCT ID
AEARCTR-0001071
Initial registration date
March 02, 2016
Last updated
March 02, 2016 2:44 PM EST
Location(s)
Region
Primary Investigator
Affiliation
UCL & IFS
Other Primary Investigator(s)
PI Affiliation
Centre for the evaluation of development policy, Institute for Fiscal Studies, London
PI Affiliation
Department of Economics Yale University and NBER
PI Affiliation
UCL Institute of Child Health, London
PI Affiliation
Institute of Education, London WC1H 0AL, UK
PI Affiliation
Mathematica Policy Research, Princeton, NJ, USA
Additional Trial Information
Status
Completed
Start date
2010-02-01
End date
2011-12-31
Secondary IDs
ISRCTN18991160
Abstract
Objective: To assess the effectiveness of an integrated early child development intervention, combining stimulation and micronutrient supplementation and delivered on a large scale in Colombia, for children’s development, growth, and hemoglobin levels.

Design: Cluster randomized controlled trial, using a 2×2 factorial design, with municipalities assigned to one of four groups: psychosocial stimulation, micronutrient supplementation, combined intervention, or control.

Setting: 96 municipalities in Colombia, located across eight of its 32 departments.

Participants: 1420 children aged 12-24 months and their primary carers.

Intervention: Psychosocial stimulation (weekly home visits with play demonstrations), micronutrient sprinkles given daily, and both combined. All delivered by female community leaders for 18 months.
Main outcome measures: Cognitive, receptive and expressive language, and fine and gross motor scores on the Bayley scales of infant development-III; height, weight, and hemoglobin levels measured at the baseline and end of intervention.

Results: Stimulation improved cognitive scores (adjusted for age, sex, testers, and baseline levels of outcomes) by 0.26 of a standard deviation (P=0.002). Stimulation also increased receptive language by 0.22 of a standard deviation (P=0.032). Micronutrient supplementation had no significant effect on any outcome and there was no interaction between the interventions. No intervention affected height, weight, or hemoglobin levels.

Conclusions: Using the infrastructure of a national welfare program we implemented the integrated early child development intervention on a large scale and showed its potential for improving children’s cognitive development. We found no effect of supplementation on developmental or health outcomes. Moreover, supplementation did not interact with stimulation. The implementation model for delivering stimulation suggests that it may serve as a promising blueprint for future policy on early childhood development
Registration Citation
Citation
Attanasio, Orazio et al. 2016. "Using the infrastructure of a conditional cash transfer program to deliver a scalable integrated early child development program in Colombia: cluster randomized controlled trial." AEA RCT Registry. March 02. https://doi.org/10.1257/rct.1071-1.0.
Former Citation
Attanasio, Orazio et al. 2016. "Using the infrastructure of a conditional cash transfer program to deliver a scalable integrated early child development program in Colombia: cluster randomized controlled trial." AEA RCT Registry. March 02. https://www.socialscienceregistry.org/trials/1071/history/7094.
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Experimental Details
Interventions
Intervention(s)
Target households receive four types of interventions: weekly psychosocial stimulation visits, micronutrient sprinkles consumed daily, both combined and control. All were delivered weekly by female community leaders for 18 months.

Psychosocial stimulation: Home visitors made weekly home visits where they demonstrated play activities using low cost or homemade toys, picture books, and form boards. These materials were left in the homes for the week after the visit and were changed weekly. The aims of the visits were to improve the quality of maternal-child interactions and to assist mothers to participate in developmentally appropriate learning activities, many centered on daily routines.

Micronutrient sprinkles: The micronutrient supplementation consisted of Sprinkles—encapsulated micronutrients in powder form—developed to treat childhood anemia. Each single dose sachet contains 12.5 mg iron, 5 mg zinc, vitamin A 300 μg retinol equivalents, 160 μg folic acid, and 30 mg vitamin C. Sachets, which include a pictorial representation of use, were delivered to households every two weeks. At the beginning of the study, home visitors also provided mothers with a monitoring booklet with use and storage instructions and forms for recording intake, which were checked by home visitors regularly. Households were provided with enough sachets for all children aged less than 6 years to prevent reduction of dose from sharing and for ethical reasons.

Both combined: Households receive both psychosocial stimulation and micronutrient sprinkles.

Control: Household receives no intervention.

Interventions were delivered by home visitors selected from the existing madre líder (mother leader), who acts as a liaison between approximately 50 beneficiary families and local program officials of the Familias en Acción conditional cash transfer program. In areas where the mother leader could not perform this role, a community member was identified by the mother leader as a replacement. The home visitors delivering the psychosocial stimulation received pre-service training lasting for two weeks, with an additional week of training one to two months after the program began.
Intervention Start Date
2010-02-01
Intervention End Date
2011-12-31
Primary Outcomes
Primary Outcomes (end points)
Primary outcomes:
1. Children’s motor and mental development: cognitive, receptive language, expressive language, fine motor, and gross motor scales in the Bayley-III.
2. Children’s nutritional status: haemoglobin levels, height, weight.

Secondary outcomes:
1. Household investment in the quality of the home environment
2. Maternal depression
Primary Outcomes (explanation)
Primary outcomes:
1. Measured using the Bayley scales of infant and toddler development, third edition (Bayley-III)
2. Hb level was assessed using Hemocue Hb 201 microcuvette machines (distributed by Vital Tecnologia, Colombia); weight was measured using a scale (SECA 872) accurate to 0.1 kg; and length (height at post-intervention) was measured using wooden length boards (ShorrBoards; Proveedor Shorr Productions, MD) accurate to 1 mm

Secondary outcomes:
1. Household investment in the quality of home environment measured using the number of varieties of play materials in the home that the child often played with and the number of play activities the child engaged in with an adult over the three days before the interview, from UNICEF’s family care indicator
2. Maternal depression measured using the Spanish translation of the Center for Epidemiologic Studies short depression scale (CES-D 10)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
To identify the sample, eight departments located in three geographical regions proximate to Bogotá: Cundinamarca, Boyacá, and Santander (oriental region); Antioquia, Risaralda, and Caldas (coffee zone region); and Huila and Tolima (central region) were selected. Within each of these three regions, 32 municipalities (clusters) in which Familias en Acción was operational was selected.

Mother leaders - who act as liaison between approximately 50 beneficiary families and local program officials of the Familias en Acción conditional cash transfer program - in each sample municipality were located and three of them randomly selected per municipality. Door to door house listing was conducted among all beneficiary households to identify families with children in the target age range (12-24 months at enrolment). Among these families, five were randomly selected to be enrolled in the study.

The intervention was phased in between February – May 2010 and phased out between September – December 2011.
Experimental Design Details
Randomization Method
Computer generated codes were used to randomly assign 8 clusters from each region to each treatment arm: psychosocial stimulation, micronutrient supplementation, both combined, and control. Version 9.0 of the data analysis and statistical software STATA (StataCorp, College Station, TX) was used for this purpose.
Randomization Unit
Municipality
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
96 municipalities
Sample size: planned number of observations
1,420 children
Sample size (or number of clusters) by treatment arms
Control: 24 municipalities, n=351 children
Stimulation: 24 municipalities, n=360 children
Micronutrient Supplementation: 24 municipalities, n=358 children
Both stimulation and micronutrient interventions: 24 municipalities, n=360 children
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Sample size was designed to detect an effect of 0.33 of a standard deviation of a Bayley scale on infant development for either the stimulation only group or the micronutrient supplementation only, against the control group. Similar interventions attained this effect size in efficacy studies in Bangladesh. This sample provided 80% power and 5% significance level, allowing for an attrition rate of 10% with 24 villages per intervention and assuming an intracluster correlation of 0.09 in the outcome. This level of intracluster correlation had been estimated from a sample of rural Mexican children who were part of the evaluation of a conditional cash transfer program. It turned out to be conservative as we had an intracluster correlation of 0.04, conditional on observables, in our baseline sample.
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
University College London research ethics committee
IRB Approval Date
2009-01-28
IRB Approval Number
1827/001
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
Yes
Intervention Completion Date
December 31, 2011, 12:00 AM +00:00
Is data collection complete?
Yes
Data Collection Completion Date
December 31, 2011, 12:00 AM +00:00
Final Sample Size: Number of Clusters (Unit of Randomization)
96 municipalities
Was attrition correlated with treatment status?
No
Final Sample Size: Total Number of Observations
1,263 children
Final Sample Size (or Number of Clusters) by Treatment Arms
Control: 24 municipalities, n=318 children Stimulation: 24 municipalities, n=318 children Micronutrient Supplementation: 24 municipalities, n=308 children Both stimulation and micronutrient interventions: 24 municipalities, n=319 children
Data Publication
Data Publication
Is public data available?
Yes
Program Files
Program Files
Yes
Program Files URL
Reports and Papers
Preliminary Reports
Relevant Papers
Abstract
ESTIMATING THE PRODUCTION FUNCTION FOR HUMAN CAPITAL: RESULTS FROM A RANDOMIZED CONTROL TRIAL IN COLOMBIA

We examine the channels through which a randomized early childhood intervention in Colombia led to significant gains in cognitive and socio-emotional skills among a sample of disadvantaged children. We estimate production functions for cognitive and socio-emotional skills as a function of maternal skills and child's past skills, as well as material and time investments that are treated as endogenous. The effects of the program can be fully explained by increases in parental investments, which have strong effects on outcomes and are complementary to both maternal skills and child's past skills.
Citation
Attanasio, Orazio, Sarah Cattan, Emla Fitzsimons, Costas Meghir, Marta Rubio-Codina. "Estimating the Production Function for Human Capital: Results from a Randomized Control Trial in Colombia." NBER Working Paper No. 20965, February 2015.
Abstract
USING THE INFRASTRUCTURE OF A CONDITIONAL CASH TRANSFER PROGRAM TO DELIVER A SCALABLE INTEGRATED EARLY CHILD DEVELOPMENT PROGRAM IN COLOMBIA: CLUSTER RANDOMIZED CONTROLLED TRIAL

Objective: To assess the effectiveness of an integrated early child development intervention, combining stimulation and micronutrient supplementation and delivered on a large scale in Colombia, for children’s development, growth, and hemoglobin levels.

Design: Cluster randomized controlled trial, using a 2×2 factorial design, with municipalities assigned to one of four groups: psychosocial stimulation, micronutrient supplementation, combined intervention, or control.

Setting: 96 municipalities in Colombia, located across eight of its 32 departments.

Participants: 1420 children aged 12-24 months and their primary carers.

Intervention: Psychosocial stimulation (weekly home visits with play demonstrations), micronutrient sprinkles given daily, and both combined. All delivered by female community leaders for 18 months.
Main outcome measures: Cognitive, receptive and expressive language, and fine and gross motor scores on the Bayley scales of infant development-III; height, weight, and hemoglobin levels measured at the baseline and end of intervention.

Results: Stimulation improved cognitive scores (adjusted for age, sex, testers, and baseline levels of outcomes) by 0.26 of a standard deviation (P=0.002). Stimulation also increased receptive language by 0.22 of a standard deviation (P=0.032). Micronutrient supplementation had no significant effect on any outcome and there was no interaction between the interventions. No intervention affected height, weight, or hemoglobin levels.

Conclusions: Using the infrastructure of a national welfare program we implemented the integrated early child development intervention on a large scale and showed its potential for improving children’s cognitive development. We found no effect of supplementation on developmental or health outcomes. Moreover, supplementation did not interact with stimulation. The implementation model for delivering stimulation suggests that it may serve as a promising blueprint for future policy on early childhood development
Citation
Attanasio, Orazio, Camila Fernández, Emla Fizsimons, Sally Grantham-McGregor, Costas Meghir, and Marta Rubio-Codina. 2014. "Using the Infrastructure of a Conditional Cash Transfer Program to Deliver a Scalable Integrated Early Childhood Development Program in Colombia: Cluster Randomized Controlled Trial." BMJ 349:g5785.