Clinical trial NCT04978766: Promoting Early Language Development Through Parent-child Book Reading in Costa Rica
Official title: Early Childhood Interventions to Reduce Inequality in Educational Opportunities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Language Development
Keywords: Book reading
Infancy
Interactive reading
Vocabulary development
Parenting
Lead sponsor: Universidad de Costa Rica
Sponsor class: OTHER
Collaborators: name: Caja Costarricense de Seguro Social
First posted: 2021-07-27
Enrollment: 184
Sex: ALL
Minimum age (years): 15
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants will take baseline measures. After baseline, each participant will be randomly assigned to the control or the experimental group. At posttest, all measures taken at baseline will be evaluated again in all participants.
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to analyze the effect of an interactive parent-child book reading intervention. The intervention includes two components: the provision of five children's books to parent-child dyads and information about how to practice interactive book reading. The investigators expect to find an effect of this intervention on a) infants' expressive vocabulary, b) reading activity, c) parental expectations and knowledge about language development and d) parental use of interactive book reading strategies.

Detailed description: The foundations of optimal health, growth and development are forged early in life, when income-related gaps in learning opportunities already exist in Costa Rica. It is therefore important for the government to mitigate the effects of these gaps through programs targeting the development of academic, behavioral, socioemotional and economic abilities. Key to the success of such programs is to consider physical health, nutrition, responsive care and early learning. Multiple government-led initiatives in Costa Rica had been carried out in order to provide adequate programs for infants and young children. Evidence of these efforts are observed in the low rates attained in infant mortality, malnutrition and anemia, as well as the high coverage of the current immunization program. However, policies targeting early learning in children under 36 months of age are incipient and government initiatives in this regard are relatively recent.

The purpose of this study is to promote early language development, a central component of early learning. Our goal is to implement and evaluate a low-cost intervention targeting parents of infants who benefit from the existing immunization program of the public health services offered by the Caja Costarricense del Seguro Social (Costa Rican Social Security Fund).

The investigators will use an experimental design to randomly assign 15- to 17-month-old infants and their caregivers to one of two groups: a control group or an experimental group. In the experimental group, caregivers will receive a package including five children's books and 36 text messages with information on how to practice interactive book reading with their children. This information will be delivered over a period of 12 weeks. The control group will not receive any treatment during the implementation of the intervention.

In order to measure the efficacy of the intervention, the investigators will evaluate a) infants' expressive vocabulary, b) parent-child reading activity, c) parental expectations and knowledge about language development and d) parental use of interactive book reading strategies at baseline (15-17 months of age) and at posttest (18-20 months of age) in the control and the experimental group. After posttest, the control group will receive the complete intervention.

The investigators expect to find an effect of the interactive book reading intervention on a) infants' expressive vocabulary, b) reading activity, c) parental expectations and knowledge about language development and d) parental use of interactive book reading strategies.

Eligibility criteria: Inclusion criteria for infants:

* Age limits: 15 months to 17 months.
* Sex: All.
* Infant was born full term (≥ 37 weeks).
* Infant is raised in a monolingual Spanish-speaking home.

Inclusion criteria for mothers:

* Mother knows how to read and write.
* Mother has access to cell phone with internet.

Exclusion Criteria:

* Neither caregivers nor infants must have any significant known physical, mental or learning disability.

Primary outcomes:
measure: Change in infant expressive vocabulary
timeFrame: Baseline [15 to 17-months] and Posttest [18 to 20-months].
Secondary outcomes:
measure: Change in parental report of reading activities
timeFrame: Baseline [15 to 17-months] and Posttest [18 to 20-months].
measure: Change in parental expectations and knowledge about language development
timeFrame: Baseline [15 to 17-months] and Posttest [18 to 20-months].
measure: Change in parental use of interactive book reading strategies
timeFrame: Baseline [15 to 17-months] and Posttest [18 to 20-months].
Other outcomes:
Locations:
city: Santo Domingo
country: Costa Rica
facility: Área de Salud (CCSS), Santo Domingo de Heredia
state: Heredia
city: Desamparados
country: Costa Rica
facility: Área de Salud (CCSS), Desamparados 2
state: San José
Study officials:
affiliation: Universidad de Costa Rica
name: Ana M. Carmiol, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jackson-Maldonado, D., Marchman, V. A., & Fernald, L. C. (2013). Short-form versions of the Spanish MacArthur-Bates Communicative Development Inventories. Applied Psycholinguistics, 34(4), 837-868.
citation: Mol, S. E., Bus, A. G., De Jong, M. T., & Smeets, D. J. (2008). Added value of dialogic parent-child book readings: A meta-analysis. Early education and development, 19(1), 7-26.
citation: Muhinyi, A., & Rowe, M. L. (2019). Shared reading with preverbal infants and later language development. Journal of Applied Developmental Psychology, 64, 101053. https://doi.org/10.1016/j.appdev.2019.101053
citation: Suskind, D. L., Leung, C. Y., Webber, R. J., Hundertmark, A. C., Leffel, K. R., Suskind, E., Hernandez, M. W., & Graf, E. (2018). Development of the survey of parent/provider expectations and knowledge (SPEAK). First Language, 38(3), 312-331.
citation: Ministerio de Salud, Instituto Nacional de Estadística y Censos, & Fondo de las Naciones Unidas para la Infancia. (2018). Encuesta de mujeres, niñez y adolescencia (EMNA).
citation: Abraham C, Michie S. A taxonomy of behavior change techniques used in interventions. Health Psychol. 2008 May;27(3):379-87. doi: 10.1037/0278-6133.27.3.379.
citation: Black MM, Walker SP, Fernald LCH, Andersen CT, DiGirolamo AM, Lu C, McCoy DC, Fink G, Shawar YR, Shiffman J, Devercelli AE, Wodon QT, Vargas-Baron E, Grantham-McGregor S; Lancet Early Childhood Development Series Steering Committee. Early childhood development coming of age: science through the life course. Lancet. 2017 Jan 7;389(10064):77-90. doi: 10.1016/S0140-6736(16)31389-7. Epub 2016 Oct 4.
citation: Cusick SE, Georgieff MK. The Role of Nutrition in Brain Development: The Golden Opportunity of the "First 1000 Days". J Pediatr. 2016 Aug;175:16-21. doi: 10.1016/j.jpeds.2016.05.013. Epub 2016 Jun 3. No abstract available.
citation: Dreyer, B. P., Mendelsohn, A. L., & Tamis-LeMonda, C. S. (1996). Assessing the child's cognitive home environment through parental report; reliability and validity. Early Development and Parenting: An International Journal of Research and Practice, 5(4), 271-287.
citation: Instituto Nacional de Estadística y Censos. (2018). Mortalidad Infantil y Evolución Reciente 2018 I Semestre. Datos Preliminares. Volumen 1, Año 14.