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TMP-Visitas al Hogar (TMP-HV RCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03076268
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Language Development Behavioral: Treinta Millones de Palabras - Visitas al Hogar Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
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: Single (Participant)
Masking Description: Participants will not be aware of which condition they are enrolled in.
Primary Purpose: Other
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

Arm Intervention/treatment
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, Illinois
Thirty Million Words® Initiative at the University of Chicago Medicine
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
  Study Documents (Full-Text)

Documents provided by University of Chicago:

Additional Information:
Publications:
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03076268    
Other Study ID Numbers: 16-1579
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No