TMP-Visitas al Hogar (TMP-HV RCT)
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|ClinicalTrials.gov Identifier: NCT03076268|
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : October 1, 2019
Treinta Millones de Palabras- Visitas al Hogar (TMP) is designed to intervene upon mothers' knowledge, beliefs, and behavior, which in turn influences their interaction with their children, impacting children's development. The investigators will measure change in mothers' knowledge, beliefs, and behavior during and after intervention, and measure impacts on children's development across major developmental domains. Specifically, the investigators will measure mothers'
- Knowledge of child language development and the role of parents in that development
- Beliefs about the malleability of intelligence and their role in shaping their children's intelligence
- Interaction with their child, specifically their linguistic input and responsiveness to their child's communication
Concurrently, the investigators will measure children's
- Emergent oral language development, in both Spanish and English
- Social-emotional development
- Math and spatial reasoning skill development
|Condition or disease||Intervention/treatment||Phase|
|Language Development||Behavioral: Treinta Millones de Palabras - Visitas al Hogar||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||91 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The investigators will deliver the TMP Curriculum to 45 Treatment families. The TMP Curriculum is comprised of 1) 12 educational modules, 2) animations and videos of real parent-child interactions to teach parents about the science behind child brain development, and model strategies for improving parents' child-directed speech, 3) video modeling and collaborative goal setting, and 4) quantitative linguistic feedback from Language ENvironment Analysis (LENA) recordings.|
|Masking Description:||Participants will not be aware of which condition they are enrolled in.|
|Official Title:||Treinta Millones de Palabras-Visitas al Hogar Pilot Randomized Controlled Trial|
|Actual Study Start Date :||March 2, 2017|
|Actual Primary Completion Date :||August 29, 2019|
|Actual Study Completion Date :||August 29, 2019|
Experimental: Treatment Group
The investigators will deliver the TMP Curriculum to 45 Treatment families. The TMP Curriculum is comprised of 1) 12 educational modules, 2) animations and videos of real parent-child interactions to teach parents about the science behind child brain development, and model strategies for improving parents' child-directed speech, 3) video modeling and collaborative goal setting, and 4) quantitative linguistic feedback from Language ENvironment Analysis (LENA) recordings. This curriculum is delivered in Spanish.
Behavioral: Treinta Millones de Palabras - Visitas al Hogar
TMP-Visitas al Hogar is a cultural and linguistic adaptation of the TMW-Home Visiting curriculum into Spanish. The 12-module curriculum has been translated into Spanish and adapted to address concerns that are vital to mono- and bilingual Spanish-speaking families, including the broadening research base for when to introduce a second language to a child and the benefits of bilingualism.
No Intervention: Control Group
The investigators will deliver a Nutrition Curriculum to 45Control families. The Nutrition Curriculum provides information about the importance of healthy nutrition for child development, strategies for healthy eating, and meal preparation.This curriculum is delivered in Spanish.
- Change from baseline LENA scores in Adult Word Count, Conversational Turn Count, and Child Vocalizations in month 12, data aggregated by treatment group. [ Time Frame: Baseline, 12 months ]
- Change from baseline in parent knowledge about child development using the SPEAK survey in month 12, data aggregated by treatment group. [ Time Frame: Baseline, 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076268
|United States, Illinois|
|Thirty Million Words® Initiative at the University of Chicago Medicine|
|Chicago, Illinois, United States, 60637|