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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03076268
Other study ID # 16-1579
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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