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Completed

NCT Number: NCT03076268

TMP-Visitas al Hogar

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'

1. Knowledge of child language development and the role of parents in that development 2. Beliefs about the malleability of intelligence and their role in shaping their children's intelligence 3. Interaction with their child, specifically their linguistic input and responsiveness to their child's communication

Concurrently, the investigators will measure children's

1. Emergent oral language development, in both Spanish and English 2. Social-emotional development 3. Math and spatial reasoning skill development

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Key information

Conditions

Language Development

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Thirty Million Words® Initiative at the University of Chicago Medicine

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • participants (i.e. parents and their children) who live at or below 200% of the federal poverty line,
  • female caregivers with a child between the ages of 24-30 months old,
  • participants whose preferred home language is Spanish,
  • education level is less than or equal to a bachelor's degree.

Exclusion criteria

  • participants (i.e. parents and their children) who live over 200% of the federal poverty line,
  • parents under the age of 18,
  • non-female primary care giver
  • children younger than 24 months old or older than 30 months old (at start of study),
  • parents who do not have legal custody of their child,
  • parents whose child does not live with them,
  • parents who are not with their child at least two full days per week,
  • parents who are unable to commit to the intervention requirements,
  • foster parents,
  • children with significant cognitive or physical impairments, (specifically Autism Spectrum Disorder, Epilepsy, Cerebral Palsy, hearing impairment, Down Syndrome and blindness),
  • parents who have earned or are currently working toward a graduate or professional degree (e.g. M.A., M.S., M.B.A), and
  • parents whose preferred home language is not Spanish.

Treatment and study plan

Treinta Millones de Palabras - Visitas al Hogar

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

Treinta Millones de Palabras-Visitas al Hogar Pilot Randomized Controlled Trial

Acronym: TMP-HV RCT

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 10, 2017
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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