TMP-Visitas al Hogar

Language Development Clinical Trial

— TMP-HV RCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03076268
• Other study ID #: 16-1579
• Status: Completed
• Phase: N/A
• Start date: March 2, 2017
• Est. completion date: August 29, 2019

Study information

• Verified date: May 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: August 29, 2019
• Est. primary completion date: August 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Language Development

Intervention

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.

Locations

Country	Name	City	State
United States	Thirty Million Words® Initiative at the University of Chicago Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (1)

Suskind DL, Leffel KR, Graf E, Hernandez MW, Gunderson EA, Sapolich SG, Suskind E, Leininger L, Goldin-Meadow S, Levine SC. A parent-directed language intervention for children of low socioeconomic status: a randomized controlled pilot study. J Child Lang. 2016 Mar;43(2):366-406. doi: 10.1017/S0305000915000033. Epub 2015 Jun 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline LENA scores in Adult Word Count, Conversational Turn Count, and Child Vocalizations in month 12, data aggregated by treatment group.		Baseline, 12 months
Secondary	Change from baseline in parent knowledge about child development using the SPEAK survey in month 12, data aggregated by treatment group.		Baseline, 12 months

External Links

•   Click here for more information about the Thirty Million Words