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

206 Participants Needed

Trial Summary

What is the purpose of this trial?

The TMW intervention aims to foster parental behaviors that facilitate children's language emergence at a critical developmental stage, and thus will be implemented at 13-16 months of age. The investigators hypothesize that the primary effects of the TMW Intervention will significantly 1) improve low-SES parents' understanding of the importance of parent language in a child's development, 2) increase parents' linguistic interaction, responsiveness, and overall engagement with their children, and 3) increase children's language output, as measured through LENA (child vocalization count, conversational turn count), coded video interaction (number of types, tokens and utterances for both children and adults), audio recordings from The Three T's application during the video sessions, and a battery of assessments targeting linguistic and cognitive development. Furthermore, the investigators hypothesize that increased parental interaction will result in 4) an improvement in children's socioemotional development as assessed by the Social Emotional Ages and Stages Questionnaire (ASQ-SE). Finally, the investigators hypothesize that these socioemotional and linguistic gains through early development, along with sustained increased parental engagement, will be expressed in 5) increased child school readiness upon kindergarten entry as assessed by Woodcock-Johnson Psycho-Educational Battery (WJ). Added 2023: an 8th child-assessment, parent/child interaction video session, and parent surveys have been added with the original sample to measure long-term outcomes of children whose parents participated in the home visiting intervention.

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 data supports the effectiveness of the TMW Curriculum treatment for child language development?

The study on Language in Interaction Therapy (LIT) shows that focused language interventions can improve language skills in children, suggesting that structured programs like the TMW Curriculum may also be effective. Additionally, the study comparing in-person and telepractice service delivery indicates that structured language interventions can be effective in various settings, supporting the potential effectiveness of the TMW Curriculum. ^{1 2 3 4 5}

How is the TMW Curriculum treatment unique for child language development?

The TMW Curriculum is unique because it focuses on empowering parents to actively participate in their child's language development through a structured program that includes video courses and specific activities to be done at home. This approach is designed to create lasting changes in parent-child interactions, which can lead to significant improvements in children's language skills. ^{6 7 8 9 10}

Research Team

Dana Suskind, MD

Principal Investigator

University of Chicago

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Therapy of Language Disorders in Childhood: A Guideline is long overdue]. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A therapeutic milieu for establishing and expanding communicative behaviors in psychotic children. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Chances of reversibility in early sensory deprivation of the Homo vulnerabilis: A 5-year (and ongoing) prospective study. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Focused Stimulation Intervention in 4- and 5-Year-Old Children With Developmental Language Disorder: Exploring Implementation in Clinical Practice. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Comparing in-Person and Telepractice Service Delivery for Spoken Language Production and Comprehension Using the National Outcomes Measurement System. [2021]

6. England pubmed.ncbi.nlm.nih.gov

A new approach to parental involvement in language intervention programmes. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Speech and language development in a parent-infant total communication program. [2009]

8. United States pubmed.ncbi.nlm.nih.gov

Addressing qualified personnel shortages for children who are deaf or hard of hearing with an interdisciplinary service learning program. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Parent education to improve early language development: A preliminary evaluation of LENA StartTM. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

A program for achieving generalization of grammatical rules to spontaneous discourse. [2019]