Promoting Early Language Development Through Parent-child Book Reading in Costa Rica

December 14, 2023 updated by: Ana María Carmiol, Universidad de Costa Rica

Early Childhood Interventions to Reduce Inequality in Educational Opportunities

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

184

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Costa Rica
    • Heredia
      • Santo Domingo, Heredia, Costa Rica, 40301
        • Área de Salud (CCSS), Santo Domingo de Heredia
    • San José
      • Desamparados, San José, Costa Rica, 10311
        • Área de Salud (CCSS), Desamparados 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interactive Book Reading Group
Participants in this arm will take baseline measures, will receive the intervention and will take posttest measures.
Behavioral: Interactive Book Reading

The intervention is a package including five children's books and information on how to practice interactive book reading. Information includes 36 audiovisual products delivered via text messaging over a 12-week period. Products include:

  1. An introductory video about interactive book reading, along with a written list of recommendations on how to practice interactive book reading.
  2. Two videos of child development experts explaining the benefits of interactive reading.
  3. Thirty written text messages strengthening content provided in the videos.
  4. Three audio messages guiding the progress of the intervention.

Based on Abraham and Michie's (2008) taxonomy of behavior change techniques, one audiovisual product prompts specific goal settings, 13 provide instruction, one provides information on consequences, 10 prompt practice, three use follow-up prompts, one prompts self-monitoring of behavior, one models or demonstrates the behavior and six prompt barrier identification.
No Intervention: Control Group
Participants in this arm will take baseline and posttest measures. For ethical purposes, they will receive the intervention after posttest measures are taken.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in infant expressive vocabulary
Time Frame: Baseline [15 to 17-months] and Posttest [18 to 20-months].
Infant expressive vocabulary will be measured with the short form (SF) Spanish versions of the MacArthur-Bates Communicative Development Inventories (CDI). Parents will complete version I (CDI-SFI) of the inventory at baseline and version II (CDI-SFII) of the inventory at posttest. Scores on the CDI-SFI inventory range from 0 to 104. Scores on the CDI-SFII inventory range from 0 to approximately 100-135, depending on the complexity of the participant's linguistic production. For both inventories, higher scores indicate a better outcome.
Baseline [15 to 17-months] and Posttest [18 to 20-months].

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in parental report of reading activities
Time Frame: Baseline [15 to 17-months] and Posttest [18 to 20-months].
Parental report of reading activities will be measured with the Spanish version of the Reading Subscale (READ) of the Cognitive Home Environment Questionnaire (StimQ-Toddler). Scores range from 0 to 19. Higher scores indicate a better outcome.
Baseline [15 to 17-months] and Posttest [18 to 20-months].
Change in parental expectations and knowledge about language development
Time Frame: Baseline [15 to 17-months] and Posttest [18 to 20-months].
Parental report of expectations and knowledge about language development will be measured with the Spanish version of the Survey of Parent/Provider Expectations and Knowledge (SPEAK), a self-administered questionnaire assessing expectations and knowledge about early childhood cognitive and language development. Scores range from 0 to 54. Higher scores indicate a better outcome.
Baseline [15 to 17-months] and Posttest [18 to 20-months].
Change in parental use of interactive book reading strategies
Time Frame: Baseline [15 to 17-months] and Posttest [18 to 20-months].
Video recordings of parent-child dyads reading books at baseline and posttest will be analyzed for quantity of interactive book reading strategies. Videos will be first transcribed and subsequently coded according to the following coding categories: word tokens, word types, mean length of utterance, number of questions and pointing tokens. Range of scores depends on participants' communicative/linguistic production. Higher scores indicate a better outcome.
Baseline [15 to 17-months] and Posttest [18 to 20-months].

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Costa Rica

Collaborators

Caja Costarricense de Seguro Social

Investigators

  • Principal Investigator: Ana M. Carmiol, PhD, Universidad de Costa Rica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2021

Primary Completion (Actual)

September 10, 2022

Study Completion (Actual)

September 10, 2022

Study Registration Dates

First Submitted

July 20, 2021

First Submitted That Met QC Criteria

July 20, 2021

First Posted (Actual)

July 27, 2021

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 723-B9-343
  • R019-SABI-00235 (Other Identifier: Ethics Committee of the Caja Costarricense del Seguro Social)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

With participants' permission, individual participant data (IDP) will be archived in accordance with the guidelines of Costa Rican national law number 9234 (Ley de Investigación Biomédica).

IPD Sharing Time Frame

IDP that underlies results in a publication will be shared after completion of the publication process. This process will take place in accordance with the guidelines of Costa Rican national law number 9234 (Ley de Investigación Biomédica),

IPD Sharing Access Criteria

Under request and in accordance with the guidelines of Costa Rican law number 9234 (Ley de Investigación Biomédica).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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