NCT04978766

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 27, 2021

Completed
17 days until next milestone

Study Start

First participant enrolled

August 13, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2022

Completed
Last Updated

December 15, 2023

Status Verified

December 1, 2023

Enrollment Period

1.1 years

First QC Date

July 20, 2021

Last Update Submit

December 14, 2023

Conditions

Keywords

Book readingInfancyInteractive readingVocabulary developmentParenting

Outcome Measures

Primary Outcomes (1)

  • Change in infant expressive vocabulary

    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 Outcomes (3)

  • Change in parental report of reading activities

    Baseline [15 to 17-months] and Posttest [18 to 20-months].

  • Change in parental expectations and knowledge about language development

    Baseline [15 to 17-months] and Posttest [18 to 20-months].

  • Change in parental use of interactive book reading strategies

    Baseline [15 to 17-months] and Posttest [18 to 20-months].

Study Arms (2)

Interactive Book Reading Group

EXPERIMENTAL

Participants in this arm will take baseline measures, will receive the intervention and will take posttest measures.

Behavioral: Interactive Book Reading

Control Group

NO INTERVENTION

Participants in this arm will take baseline and posttest measures. For ethical purposes, they will receive the intervention after posttest measures are taken.

Interventions

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.

Interactive Book Reading Group

Eligibility Criteria

Age15 Months - 17 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Área de Salud (CCSS), Santo Domingo de Heredia

Santo Domingo, Heredia Province, 40301, Costa Rica

Location

Área de Salud (CCSS), Desamparados 2

Desamparados, Provincia de San José, 10311, Costa Rica

Location

Related Publications (10)

  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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).

    BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

    RESULT
  • Instituto Nacional de Estadística y Censos. (2018). Mortalidad Infantil y Evolución Reciente 2018 I Semestre. Datos Preliminares. Volumen 1, Año 14.

    RESULT

Study Officials

  • Ana M. Carmiol, PhD

    Universidad de Costa Rica

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
An external collaborator will create the allocation sequence for each of the two participating health centers (stratified randomization). Two independent research assistants will prepare the allocation in sequentially numbered, opaque, sealed and stapled envelopes. Aluminium foil inside each envelope will be used to render the envelope impermeable to intense light. This will allow the allocation sequence to be concealed from the researcher assessing participants at baseline. Once baseline assessment is completed, the next consecutively numbered envelope will be opened to reveal the participant's allocation. Treatment for the experimental group will be provided by two different researchers who will not participate in outcome assessment. A different researcher (outcome assessor), blind to the allocation sequence, to the participant's allocation and to the participant's baseline scores, will complete the participants' assessments during posttest.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology at Instituto de Investigaciones Psicológicas

Study Record Dates

First Submitted

July 20, 2021

First Posted

July 27, 2021

Study Start

August 13, 2021

Primary Completion

September 10, 2022

Study Completion

September 10, 2022

Last Updated

December 15, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

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).

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
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),
Access Criteria
Under request and in accordance with the guidelines of Costa Rican law number 9234 (Ley de Investigación Biomédica).

Locations