Language DevelopmentNCT04978766
Promoting Early Language Development Through Parent-child Book Reading in Costa Rica
A study testing Interactive Book Reading in people with Language Development, run by Universidad de Costa Rica at 2 sites in Costa Rica.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 17 monthsHealthy volunteers can take part
- Conditions the study is for
- Language Development
- What is being tested?
- Interactive Book Reading
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 2 sitesCosta Rica
- Study dates
- 13 Aug 2021to 10 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 17 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Neither caregivers nor infants must have any significant known physical, mental or learning disability.
Trial locations and contacts
2 sites in 1 country.
Costa Rica2 sites
Área de Salud (CCSS), Desamparados 2
Desamparados, Provincia de San José, 10311
Área de Salud (CCSS), Santo Domingo de Heredia
Santo Domingo, Heredia Province, 40301
About this study
Official title: 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.
Read the 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.
- Conditions
- Language Development
- Being tested
- Interactive Book Reading
- Keywords
- Book reading, Infancy, Interactive reading, Vocabulary development, Parenting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Book ReadingBehavioural
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:
- An introductory video about interactive book reading, along with a written list of recommendations on how to practice interactive book reading.
- Two videos of child development experts explaining the benefits of interactive reading.
- Thirty written text messages strengthening content provided in the videos.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Interactive Book Reading Group | Experimental | Participants in this arm will take baseline measures, will receive the intervention and will take posttest measures. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline [15 to 17-months] and Posttest [18 to 20-months].
Secondary outcomes (3)
Change in parental report of reading activities
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.
Measured: Baseline [15 to 17-months] and Posttest [18 to 20-months].
Change in parental expectations and knowledge about language development
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.
Measured: Baseline [15 to 17-months] and Posttest [18 to 20-months].
Change in parental use of interactive book reading strategies
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.
Measured: Baseline [15 to 17-months] and Posttest [18 to 20-months].
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start13 Aug 2021
- Primary completion10 Sep 2022
- Study completion10 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Language DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Costa Rica
- Sponsor type
- University, hospital or other
- Collaborators
- Caja Costarricense de Seguro Social
- Responsible party
- Principal investigator, Ana María Carmiol, Universidad de Costa Rica
- Investigators
- Ana M. Carmiol, PhD, Principal investigator, Universidad de Costa Rica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978766
- Sponsor's protocol ID
- 723-B9-343
- Other IDs
- R019-SABI-00235
- Status last verified
- Dec 2023
- First submitted
- 20 Jul 2021
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
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.
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.
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
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.
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).
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.
PubMed 18624603Black 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.
PubMed 27717614Cusick 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.
PubMed 27266965Dreyer, 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.
Instituto Nacional de Estadística y Censos. (2018). Mortalidad Infantil y Evolución Reciente 2018 I Semestre. Datos Preliminares. Volumen 1, Año 14.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Childhood Interventions to Reduce Inequality in Educational Opportunities
- ClinicalTrials.gov ID
- NCT04978766
- Acronym / sponsor ID
- 723-B9-343
- Conditions
- Language Development
- Keywords
- Book reading, Infancy, Interactive reading, Vocabulary development, Parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Universidad de Costa RicaUniversity, hospital or other
- Collaborators
- Caja Costarricense de Seguro Social
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- 10 Sep 2022 (actual)
- Study completion
- 10 Sep 2022 (actual)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Interactive Book Reading Group | Experimental | Behavioral: Interactive Book ReadingParticipants in this arm will take baseline measures, will receive the intervention and will take posttest measures. |
| 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. |
Who may qualify
- Ages
- 15 to 17 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- Neither caregivers nor infants must have any significant known physical, mental or learning disability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive Book ReadingThe 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. | Behavioural | Interactive Book Reading Group |
Primary outcome
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.
3 secondary outcomes
Change in parental report of reading activities
Time frame: 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].
Change in parental use of interactive book reading strategies
Time frame: Baseline [15 to 17-months] and Posttest [18 to 20-months].
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- BackgroundJackson-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.
- BackgroundMol, 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.
- BackgroundMuhinyi, 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
- BackgroundSuskind, 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.
- BackgroundMinisterio de Salud, Instituto Nacional de Estadística y Censos, & Fondo de las Naciones Unidas para la Infancia. (2018). Encuesta de mujeres, niñez y adolescencia (EMNA).
- Results publication: PubMed 18624603Abraham 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.
- Results publication: PubMed 27717614Black 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.
- Results publication: PubMed 27266965Cusick 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.
- Results publicationDreyer, 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.
- Results publicationInstituto Nacional de Estadística y Censos. (2018). Mortalidad Infantil y Evolución Reciente 2018 I Semestre. Datos Preliminares. Volumen 1, Año 14.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana M. Carmiol, PhD principal investigator
Universidad de Costa Rica
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Book Reading in people with Language Development, run by Universidad de Costa Rica at 2 sites in Costa Rica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Costa Rica. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in infant expressive vocabulary (time frame: Baseline [15 to 17-months] and Posttest [18 to 20-months].). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04978766, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.