x

NEW UPDATE: Completed trials may now upload and register supplementary documents (e.g. null results reports, populated pre-analysis plans, or post-trial results reports) in the Post Trial section under Reports, Papers, & Other Materials.
The aeioTu Longitudinal Randomized Trial
Last registered on January 17, 2017

Pre-Trial

Trial Information
General Information
Title
The aeioTu Longitudinal Randomized Trial
RCT ID
AEARCTR-0001903
Initial registration date
January 17, 2017
Last updated
January 17, 2017 2:22 PM EST
Location(s)
Primary Investigator
Affiliation
NIEER
Other Primary Investigator(s)
PI Affiliation
NIEER, Rutgers University
PI Affiliation
Universidad de los Andes
Additional Trial Information
Status
On going
Start date
2010-06-01
End date
2018-12-31
Secondary IDs
Abstract
The aeioTU Longitudinal Study is a randomized trial longitudinal study which inquires into the immediate and short-term cognitive, linguistic, nutritional and social effects of a comprehensive educational and nutritional 0-5 intervention in Colombia, in the form of aeioTU centers. The research is headed by Milagros Nores from the National Institute of Early Education Research (NIEER) in collaboration with Raquel Bernal from Universidad de los Andes in Colombia. The study is an independent evaluation that follows 1,218 children’s developmental trajectory between 2010 and 2015. This randomized longitudinal study of high-quality early education in the Colombian context is the first of its kind, by including all cohorts of children before school age and focusing on high-quality center-based education in two disadvantaged neighborhoods in the northern coastal region of Colombia. Households and children were randomly assigned from a waiting list to aeioTu or the control group. Children who won the lottery were enrolled in the two AeioTu centers in the study through lottery supervised by NIEER. The lottery was based on an oversubscription model, as the centers were built from scratch and opened to the community in 2010 and early 2011, each center only had spaces for about 300 children.
External Link(s)
Registration Citation
Citation
Barnett, W, Raquel Bernal and Milagros Nores. 2017. "The aeioTu Longitudinal Randomized Trial." AEA RCT Registry. January 17. https://doi.org/10.1257/rct.1903-1.0.
Former Citation
Barnett, W et al. 2017. "The aeioTu Longitudinal Randomized Trial." AEA RCT Registry. January 17. http://www.socialscienceregistry.org/trials/1903/history/13204.
Sponsors & Partners

There are documents in this trial unavailable to the public. Use the button below to request access to this information.

Request Information
Experimental Details
Interventions
Intervention(s)
The intervention is the program aeioTU: high quality early childhood services to children under the age of 5. In addition, it supports other early childhood providers and professionals interested in providing comprehensive services through various quality improvement supports. aeioTU is a social enterprise that works in through public-private partnerships and currently provides services to in 13 cities serving 3,300 niños daily, and working with teachers across the country having an impact on over 50,000 children.
The aeioTu program became of particular interest to the researchers because of its high quality components. That is, the program is:
 Full Day;
 Add additional 25% in funds per child (into teachers and nutrition);
 70% of nutritional intake requirements, plus nutritional monitoring;
 High qualifications requirements for staff;
 Pre- and on-service training;
 Strong support staff and services;
 Monitoring and information system;
 Family and community participation;
 Strong curriculum developed inspired on Reggio Emilia.
Read more on aeioTu on their website.
Intervention Start Date
2010-11-01
Intervention End Date
2015-12-31
Primary Outcomes
Primary Outcomes (end points)
Various instruments are used to assess different dimensions of child development. Linear models, hierarchical linear modeling, and classroom random effect models are used to estimate impact and the role of moderators. We use instruments that evaluate children’s emotional, social and cognitive development over time. We also measure family characteristics, program costs (direct and indirect) and program quality.
Instruments vary with children’s age, as cohorts progress through pre-k, kindergarten and into primary. We assess children’s early cognition and motor skills, receptive vocabulary, emergent literacy, early math skills, and socio-behavioral abilities and schooling outcomes each academic year. We assess these specific abilities to observe the effects of treatment on brain development and cognitive capacities that emerge as various areas of the brain mature. Assessing specific abilities allows inferences concerning the periods of development and specific brain areas that are vulnerable, and may shed light on the biological and psychological mechanisms through which interventions affect child development. Specific instruments and indicators used are:
i. Family Background and Home Environment questionnaires: Parents questionnaires collect information on parental ethnicity, parental income, savings, education, employment, welfare, family composition, immunization living conditions, parenting practices and information on the early childhood experiences.
ii. Infant Development: The Bayley Scales of Infant Development (BSID) are the most commonly used assessment of infant development (Fernald, Kariger, Engle & Raikes, 2009; Bayley, 2005). The Bayley has shown to predict later non-verbal and verbal cognition, i.e. as measured by the Test de Vocabulario en Imágenes Peabody (TVIP) (Blaga, Shaddy, Anderson, Kannass, Little & Colombo, 2009). As children grow, we measure child development using the Vineland Adaptive Behavior Scales (Sparrow, Balla, & Cicchetti, 1985). The Vineland is an individual parent questionnaire that assesses personal and social skills in communication, daily living skills, socialization, and motor skills.
iii. Language: The Test de Vocabulario en Imágenes Peabody (TVIP) (Dunn, Padilla, Lugo and Dunn, 1986) uses 125 items to assess receptive vocabulary of Spanish-speaking students. The TVIP has been used extensively in preschool studies (Early, Maxwell, Burchinal, Alva, Bender, Bryant, et al., 2007).
iv. Math and Literacy: The Woodcock-Muñoz III Tests of Achievement (WM-III) The WM-III is a comprehensive set of individually administered tests of children’s early literacy and mathematical skills and knowledge, and we use subtests #1, #9 and #10, letter-word identification, text comprehension and applied problems, respectively (Muñoz-Sandoval, Woodcock, McGrew & Mather, 2005). In addition, in the first waves the Early Literacy Skills Assessment (ELSA) (DeBruin-Parecki, 2005) measures four key elements of early literacy development– comprehension, phonological awareness, alphabetic principle, and concepts about print.
v. Socio-emotional Development: The Ages and Stages Questionnaires for the Socio-Emotional domain (ASQ: SE) (Squires, Bricker and Twombly, 2009) is a parent-completed assessment for children ages 6-60 months on socio-emotional development. The ASQ has been used for early development assessments in low and middle income countries (Handal, Lozoff, Breilh and Harlow, 2007; Tsai, McClelland, Pratt & Squires, 2006). As children grow older, we switch to the Behavior Assessment System for Children (BASC-II), which measures adaptive and problem behaviors (Bracken, Keith, & Walker, 1998; Doyle, Ostrander, Skare, Crosby & August, 1997) and the Strengths and Difficulties Questionnaire (Goodman, 1997).
vi. Executive Function: Head-Toes-Knees and Shoulders: The HTKS examines behavioral regulation (Ponitz, McClelland, Matthews & Morrison, 2009; Ponitz, McClelland, Jewkes, Conner, Farris & Morrison, 2008) in children’s early years. HTKS requires children to remember and respond to behavioral commands. It has predictive validity with achievement and teacher-ratings of self-regulation. In addition, after the third wave we incorporate the following set of instruments, in order to have a stronger and more comprehensive battery for this dimension: Peg Tapping Task (Diamond and Taylor, 1996); Dimensional Change Card Sort (Zelazo, 2006) and Copy Design (Osborne, Butler and Morris, 1984).
vii. Children’s health status: In line with similar international studies (Fernand, Gertler & Neufeld, 2008; Overholt, Sellers, Mora, Paredes & Herrera, 1982; Walker, Wachs, Meeks Gardner, et al., 2004) we collect information on height and weight, BMI and arm circumference once a year following World Health Organization (WHO) standards.
Primary Outcomes (explanation)
Outcomes at end points followed those above quite closely.
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
The project uses a two-site, randomized trial with a longitudinal design. Program quality is monitored. Analyses investigate main effects and interactions using a person-process-context model that includes family and community characteristics. Participants are 1217 low-income children and their families. The study addresses the following questions:
 What are the immediate and short-term effects of enrollment and participation in aeioTu on children’s early learning and development?
 To what extent do these effects vary by intensity (cohorts)?
 Do pre-school effects persist over time, and in particular as children transition to primary?
 How do child and family characteristics moderate the effects on children?
 What is the cost-effectiveness of this intervention?
Experimental Design Details
Randomization Method
Public lottery. We used computer generated random lists to assign children to treatment or to an ordered waiting list.
Randomization Unit
Families.
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
n/a
Sample size: planned number of observations
1,200 children.
Sample size (or number of clusters) by treatment arms
n/a
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Power analyses indicated a power of 1 with a sample size of 1200 children and above .85 for sample sizes of 700, which would accommodate subgroup analyses for infants and toddlers versus preschoolers (α=0.05, effect size at 0.25sd following Nores and Barnett, 2010).
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Universidad de Los Andes, Comite de Etica
IRB Approval Date
2009-10-15
IRB Approval Number
032-2009
IRB Name
Rutgers IRB
IRB Approval Date
2009-07-13
IRB Approval Number
E09-568
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports, Papers & Other Materials
Relevant Paper(s)
REPORTS & OTHER MATERIALS