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 Effect of a Home-Based Community Visits on Early Childhood Development in Bolivia
Initial registration date
June 05, 2017
June 05, 2017 5:02 PM EDT
Other Primary Investigator(s)
Inter-American Development Bank
Inter-American Development Bank
Additional Trial Information
Ethics Research Commission of the National Bioethics Committee (CEI-CNB) approval letter October 2014
Prevailing deficits in developmental stages at a very early age have been long documented in developing countries (Grantham-McGregor, 2007) and in Latin America (Schady et al, 2006). Low-quality health and nutrition services and limited interaction between parents and children in poor home environments may all contribute towards poor cognitive and overall early childhood development (ECD). In particular, deficits of psychosocial stimulation lead to increasing inequality in early childhood stages (Walker et al, 2011) that can have life-long consequences, including lower levels of school participation and performance, lower future earnings and income, increased reliance on the health care system and higher rates of criminality (Walker et al, 2011; Naudeau et al, 2010).
The evidence from recent research suggests that well targeted and defined early interventions can accrue positive and sustainable development outcomes (Engle et al 2011, Hoddinott et al, 2008; Gertler et al, 2014). Besides the design of center-based interventions that have proven to be effective (Martinez et al, 2012; Noboa-Hidalgo and Urzúa, 2012), psychosocial stimulation programs based on home visiting models have demonstrated positive short term and long term effects (Gertler et al, 2014; Grantham-McGregor, 1991). A recent publication by Attanasio et al (2014) has found positive effects on cognition (0.260 SD) and receptive language outcomes (0.218 SD) from a home visits intervention in Colombia.
The Early Childhood Development Unit (UDIT) within the Bolivia’s Ministry of Health (MS) is launching a pilot program in the departments of Chuquisaca and Potosi which aims to improve the cognitive, socioemotional and physical development of vulnerable children under four years of age through increased access to early intervention services. The program will target vulnerable families with children under 4 years of age and encompasses a series of components financed by a loan from the Inter-American Development Bank. One of the key program components is a home visiting model intervention in eligible urban neighborhoods and rural communities. Home visits include psychosocial and stimulation curricula to interact with children and mothers. The program includes an experimental impact evaluation design where eligible neighborhoods and communities are randomly assigned to treatment and control groups. The evaluation will estimate effects of home visits on child care practices and inputs, and on early childhood development outcomes, including gross and fine motor skills, cognitive and language. Results will inform national policy in Bolivia and will provide evidence on the cost effectiveness of home visits to increase performance in early development outcomes and narrow down development gaps. Registration Citation
Johannsen, Julia, Sebastian Martinez and Cecilia Vidal. 2017. "The Effect of a Home-Based Community Visits on Early Childhood Development in Bolivia ." AEA RCT Registry. June 05.
The home visit intervention will follow the “Reach Up Early Childhood Parenting Programme” model (http://www.reachupandlearn.com/), originally developed in Jamaica (Grantham-McGregor and Desai, 1975; Walker et al, 2000; Gertler et al, 2014; Grantham-McGregor and Smith, 2016;) and adapted in Latin America to the Colombian and Peruvian context (Attanasio et al, 2014; Rubio-Codina et al, 2016).
Program staff teams will visit eligible households with children 6-36 months of age where they will follow psychosocial and stimulation curricula to interact with children and primary caregivers. Visits will occur once every week for approximately 1 hour. Home visitors will engage children and parents into play activities using low-cost homemade toys, picture books and other items. Caregivers will receive first hand parent-child interactions models for effective best practices to stimulate children psychomotor, cognitive and language skills that they can later replicate.
Treatment neighborhoods and communities within program municipalities will be grouped into geographic areas of intervention adding up to 3-5 communities that will be served by a designated staff team consisting of 1 tutor and 1-3 community agents.
Community agents are local program staff living in these communities that will be trained in ECD protocols. They are responsible for conducting the home visits. Tutors are professionals within the ECD field with relevant experience and knowledge in ECD interventions. They have the role of supervising community agents work in the field, offering guidance and feedback while ensuring correct application of protocols. Tutors will provide support and sustain home visitors’ motivation during the implementation. In those communities where community agents cannot serve all eligible households, tutors will also conduct home visits themselves, in direct interaction with parents and children.
Intervention Start Date
Intervention End Date
Primary Outcomes (end points)
The purpose of this research is to assess the impact of the home-based early intervention services on a variety of child and family outcomes:
Key Intermediate Outcomes
• Quantity and quality of child stimulation and availability of child support in the home environment
Key Final Outcomes
• ECD indicators for children under 3 years of age including cognitive, language, gross and fine motor development, and socio-emotional skills.
Primary Outcomes (explanation)
The first follow up survey will take place between October and December 2017 and will collect information from 240 primary sampling units (PSU) in urban and rural areas of the departments of Chuquisaca and Potosi. Each PSU corresponds to a neighborhood in urban areas and to a community in rural areas. In urban PSUs, 12 randomly selected households with children 12-30 months of age will be interviewed. In rural PSUs, the survey will collect information from all eligible households, with an average of 8 households per community. In total, the evaluation sample will contain approximately 2,320 observations (1,120 in rural areas and 1,200 in urban areas).
The survey instrument will be designed to collect data on: 1. Household Questionnaire (applied to household head) - Sociodemographic characteristics of household members
- Education - Labor participation and household income
- Household characteristics and access to services
- Household assets
2. Child Questionnaire (applied to primary caregiver)
- Health and nutrition indicators, including access to health services
- Child care practices and inputs to measure home environment (Family Care Indicators and a short version of the Infant/Toddler Home Observation for Measurement of the Environment).
- Caregiver’s emotional status
- Early childhood development, including the Ages and Stages Questionnaire and the MacArthur-Bates Communicative Development Inventories. The application of ECD standardized tests in the follow up survey will measure development indicators including cognitive, language and gross and fine motor development, socio-emotional skills. All survey instruments will be used with adequate adaptation for the application in the local context.
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
The impact evaluation will be based on the design of a Randomized Controlled Trial (RCT). Within each program municipality, eligible neighborhoods/communities were randomly assigned an order of entrance to the program and listed accordingly. Neighborhoods/communities at the top of the list were assigned to the intervention group (324) leaving the remaining neighborhoods/communities as controls (375). The number of units that were offered the treatment was based on program resources available.
The randomization process was carried out between May and July of 2013 through public lotteries witnessed by local and UDIT authorities to ensure transparency and legitimacy.
Experimental Design Details
Within each municipality treatment was assigned at the neighborhood level in urban areas and at the community level in rural areas. Treatment assignment was stratified by municipality and area. In highly populated municipalities, treatment assignment was, in addition, stratified by health district and health center.
Was the treatment clustered?
Sample size: planned number of clusters
Planned number of clusters: 240 neighborhoods/communities (120 treatment and 120 control).
Sample size: planned number of observations
Planned number of observations: 2,320 households
- Treatment: 1,160 households
o Urban area: 600 households
o Rural area: 560 households
- Control: 1,160 households
o Urban area: 600 households
o Rural area: 560 households
Sample size (or number of clusters) by treatment arms
The study includes one treatment arm with 120 clusters in the treatment group and 120 clusters in the control group.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Minimum detectable effect sizes were estimated using baseline data on the ASQ child development questionnaire, with a minimum effect of 2.32 (relative effect of 6%) on the global score. The largest MDE for sub-domains is on communication, with an effect of 3.35 points (relative effect of 8.8%). Other sub-domains include gross motor, fine motor, cognitive and socio-emotional.
INSTITUTIONAL REVIEW BOARDS (IRBs)
Comisión de Ética de la Investigación del Comité Nacional de Bioética (CEI-CNB)
IRB Approval Date
IRB Approval Number
Approval letter provided
Post Trial Information
Is the intervention completed?
Is data collection complete?