NCT03076268

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. 1.Knowledge of child language development and the role of parents in that development
  2. 2.Beliefs about the malleability of intelligence and their role in shaping their children's intelligence
  3. 3.Interaction with their child, specifically their linguistic input and responsiveness to their child's communication
  4. 4.Emergent oral language development, in both Spanish and English
  5. 5.Social-emotional development
  6. 6.Math and spatial reasoning skill development

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

March 2, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 10, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2019

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

2.5 years

First QC Date

March 2, 2017

Last Update Submit

May 9, 2023

Conditions

Outcome Measures

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.

    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.

    Baseline, 12 months

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

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.

Treatment Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thirty Million Words® Initiative at the University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Related Publications (2)

  • 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.

    PMID: 26041013BACKGROUND
  • List JA, Pernaudet J, Suskind DL. Shifting parental beliefs about child development to foster parental investments and improve school readiness outcomes. Nat Commun. 2021 Oct 1;12(1):5765. doi: 10.1038/s41467-021-25964-y.

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not be aware of which condition they are enrolled in.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2017

First Posted

March 10, 2017

Study Start

March 2, 2017

Primary Completion

August 29, 2019

Study Completion

August 29, 2019

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations