TMW Program for Child Language Development

(TMW HV RCT Trial)

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Over 200% poverty, Under 18, Autism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 21

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a special program can help parents improve their child's language and social skills. The program targets parents living near the federal poverty line with children aged 13-16 months. Participants will either follow a nutrition program or a language-focused curriculum (TMW Curriculum) designed to increase parent-child communication. The goal is to determine if increased talking and interaction from parents can boost children's language and social development, ultimately preparing them better for school. Eligible parents must live below 250% of the federal poverty line and have children aged 13-16 months. As an unphased trial, this study offers parents a unique opportunity to actively contribute to research that may enhance their child's future educational success.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the TMW Curriculum is safe for child language development?

Research has shown that the TMW Curriculum is safe for families. This program helps parents engage more effectively with their children through educational modules, videos, and animations. It aims to improve children's language skills by enhancing parental communication.

The TMW Curriculum has been used in previous studies without reports of harmful effects. It promotes healthy interactions between parents and children. As an educational program, not a medical treatment, it lacks the side effects associated with medicines. Participants in those studies reported positive experiences, highlighting the program's focus on boosting language and cognitive development in children.

While specific safety data is limited, the nature of the TMW Curriculum suggests it is well-tolerated. Its emphasis on education and interaction aims to improve communication rather than provide medical intervention, making it a low-risk option for families interested in joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TMW Curriculum because it offers a unique approach to enhancing child language development by focusing on improving parent-child interactions. Unlike traditional methods that may solely emphasize direct child education, this program includes 12 educational modules and uses animations and videos to teach parents about brain development. It also provides quantitative feedback using Language ENvironment Analysis (LENA) recordings, allowing for personalized insights into a child's linguistic environment. This innovative approach not only empowers parents with actionable strategies but also aims to foster a richer language environment, potentially leading to better outcomes in child language development.

What evidence suggests that the TMW Curriculum is effective for child language development?

Studies have shown that the TMW Curriculum, which participants in this trial may receive, helps parents create better language environments for their children. After joining the program, parents increased their communication with their children, which is crucial for language development. Early research indicates that children in the program engaged in more conversations with their parents. This interaction enhances their language skills and supports their social and emotional growth, preparing them for school. The program has received positive reviews in real-world settings, benefiting over 3,000 families and showing promising results in language and cognitive skills for toddlers. ^{1 6 7 8 9}

Who Is on the Research Team?

Dana Suskind, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for parents and their children living at or below 250% of the federal poverty line, where the highest level of parental education is a bachelor's degree. It targets families with children aged 13-16 months to improve language development through home visits.

Inclusion Criteria

My family's income is at or below 250% of the federal poverty line.

My father's highest education is a bachelor's degree or less.

My child is between 13 to 16 months old.

Timeline for a Trial Participant

Recruitment

Participants are recruited and complete Preliminary Enrollment Consent

4 weeks

In-home visits for baseline measurements

Enrollment

Participants complete Enrollment Consent and are randomized into Treatment or Control groups

1 week

In-home visit for Video 1 and randomization

Intervention

Participants receive 12 bi-weekly home visits over six months with educational curricula

6 months

12 in-home visits

Follow-up

Participants complete assessments and video sessions to monitor long-term outcomes

42 months

Multiple in-home visits for assessments and video sessions

Long-term Follow-up

Additional assessments and video sessions when children reach 9-10 years old

Ongoing

In-home visits for Assessment 8 and Video Session 8

What Are the Treatments Tested in This Trial?

Interventions

• TMW Curriculum

Trial Overview

The TMW (Thirty Million Words) intervention focuses on enhancing parent-child interactions to boost children's language skills and socioemotional development. The study compares TMW with a nutrition curriculum, measuring outcomes like vocalization and school readiness.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

We will deliver the TMW Curriculum to 106 Treatment families. The TMW 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.

Group II: Control Group Experimental Treatment 1 Intervention

We will deliver a Nutrition Curriculum to 100 Control families. The Nutrition Curriculum provides information about the importance of healthy nutrition for child development, strategies for healthy eating, and meal preparation.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Published Research Related to This Trial

The LENA Start™ program, which trains parents to enhance language interactions, showed positive trends in child vocalizations and conversational turns among participants, with 72% successfully completing the program.

In contrast, families in a generic parent education program experienced declines in these language measures, suggesting that LENA Start™ may be more effective in fostering quality parent-child language interactions, although the results were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent education to improve early language development: A preliminary evaluation of LENA StartTM. Elmquist, M., Finestack, LH., Kriese, A., et al.[2021]

A rehabilitation program significantly improved language skills in vulnerable children with sensory deprivation, but differences in language abilities persisted even after intervention.

Early intervention is crucial; starting rehabilitation before age 5 may lead to better outcomes, highlighting the importance of addressing sensory deficits as soon as possible for social inclusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chances of reversibility in early sensory deprivation of the Homo vulnerabilis: A 5-year (and ongoing) prospective study. Goycoolea, MV., Levy, R., Bustamante, MP., et al.[2019]

Language in Interaction Therapy (LIT) is an effective intervention for improving morphosyntactic skills in 4- to 5-year-old children with developmental language disorders, as demonstrated by a single-case study involving five children.

The study found that four out of five children showed increased mean length of utterance during LIT compared to baseline, with significant improvements in two cases, indicating that LIT can enhance language development when properly implemented with support and structured protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focused Stimulation Intervention in 4- and 5-Year-Old Children With Developmental Language Disorder: Exploring Implementation in Clinical Practice. Bruinsma, G., Wijnen, F., Gerrits, E.[2020]

Citations

1.

withpower.com

withpower.com/trial/phase-10-2014-96e36

TMW Program for Child Language Development · Info ...

The investigators hypothesize that the primary effects of the TMW Intervention will significantly 1) improve low-SES parents' understanding of the importance of ...

2.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/73/NCT04027673/Prot_SAP_001.pdf

Version Date 07/19/2019

Therefore,. TMW-ECE aims to increase educator knowledge of early childhood language development and to identify the most effective way to translate this ...

3.

tmwcenter.uchicago.edu

tmwcenter.uchicago.edu/resources/tmw-center-newsletter-july-2019/

TMW Center Newsletter July 2019

Results continue to show that TMW parents provided more enriched home language environments for their toddlers after the intervention than the ...

4.

uchicagomedicine.org

uchicagomedicine.org/forefront/pediatrics-articles/2019/january/gift-to-tmw-enter-for-early-learning-public-health-will-boost-efforts-to-improve-outcomes-in-children

Gift to TMW Center will boost efforts to improve outcomes in ...

To date, TMW Center programs have reached more than 3,000 families in the Chicago area alone, with early results indicating an increase in ...

5.

trial.medpath.com

trial.medpath.com/clinical-trial/91ed6cd45ce317ed/nct04330131-tmw-center-early-learning-public-health

TMW Community-Wide Demonstration Project | MedPath

To compare outcomes and evaluate effectiveness of the interventions, a comparison community will be selected beginning in 2021. To define the sample ...

6.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/32/NCT02216032/Prot_SAP_004.pdf

ID: __________ 1 PROTOCOL VERSION DATE: 09/06/2023

The TMW Curriculum is comprised of 1) 12 educational modules,. 2) animations and videos of real parent-child interactions to teach parents about the science.

7.

tmwcenter.uchicago.edu

tmwcenter.uchicago.edu/resources/early-parental-knowledge-and-conversations-promote-language-skills/

Early Parental Knowledge and Parent-Child Conversations ...

This randomized controlled trial examined the long-term impact of the 3Ts-HV intervention on preschool-aged children's language skills ...

8.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0165587621001567

Leveraging the universal newborn hearing screen to ...

Considering this, the TMW-Newborn video was revised to include more explicit illustrations of parental engagement with the child, repeating examples, and ...

9.

speechbuddy.com

speechbuddy.com/blog/language-development/building-a-childs-brain-with-the-thirty-million-words-initiative/?srsltid=AfmBOorbAOKJ0CzVPdQL7R41677m9Sx50zBdZ_xoGmhXoSxW11f863T1

Building a Child's Brain with the Thirty Million Words Initiative

The TMW is a parent-directed program, which emphasizes parent and child interaction in an attempt to effectively close the achievement gap. The ...