Talk With Me Baby for Infant Language Development

(TWMB Trial)

Recruiting at 1 trial location

Overseen By Song Ounpraseuth, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: IDeA States Pediatric Clinical Trials Network

Disqualifiers: Cognitive impairment, Developmental delay, others

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

Compensation: Varies

Number of Visits: 4

Duration: 4 visits

66 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if the Talk With Me Baby (TWMB) program improves the home-language environment for at-risk families with children ages two to six months when primary care providers deliver the program during well-child checkups. The main question it aims to answer is: Will the TWMB program increase the time a caregiver talks to their infant? Participants will: 1. Come to at least four well-child checkups 2. Receive the TWMB program from the provider during the checkups 3. Record their conversations with their infant before they receive the program and after they receive the program four times.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems unlikely that you would need to stop, as the trial focuses on language development and not on medication use.

What data supports the effectiveness of the treatment Talk With Me Baby for infant language development?

Research shows that parent coaching, which is similar to the Talk With Me Baby treatment, can improve language outcomes in infants. Studies found that coaching parents to enhance their language interactions with their babies led to better language skills, such as increased vocabulary and more complex speech, in children up to 30 months old. ^{1 2 3 4 5}

How does the Talk With Me Baby treatment differ from other treatments for infant language development?

Talk With Me Baby is unique because it focuses on enhancing the quality of interactions between infants and caregivers to support language development, rather than using traditional medical or educational interventions. This approach emphasizes the importance of dyadic joint attention (shared focus between caregiver and child) and improving parent-child interactions in the home environment, which is not commonly addressed in other treatments. ^{2 6 7 8 9}

Eligibility Criteria

This trial is for families with children aged 2-6 months who may be at risk of language development issues. Caregivers must commit to attending at least four well-child checkups and recording their conversations with their infant before and after receiving the TWMB program.

Inclusion Criteria

My child is 2-6 months old, born full-term and not part of a multiple birth, and sees a doctor at a participating clinic.

Caregiver (dyad) must have a LENA baseline assessment score that is ≤ 75th percentile compared to a child's age-referenced normative data

The child of the above caregiver for whom the WCC visits are conducted

Exclusion Criteria

Child has significant developmental delay or cognitive, visual, or hearing impairment, or previously attended a WCC visit during the TWMB trial period.

My caregiver cannot make decisions well due to cognitive, visual, or hearing issues, doesn't live with me or spend enough time with me, or doesn't plan to continue my clinic visits for a year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Talk With Me Baby (TWMB) program during well-child checkups

4 visits

4 visits (in-person)

Follow-up

Participants record their conversations with their infant before and after receiving the program

4 weeks

Treatment Details

Interventions

• Talk With Me Baby

Trial Overview The study tests if the 'Talk With Me Baby' (TWMB) program, given by primary care providers during regular checkups, can increase how much caregivers talk to their infants, potentially enhancing language development in early childhood.

Participant Groups

Group I: Talk With Me Baby Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

IDeA States Pediatric Clinical Trials Network

Lead Sponsor

Trials

8

Recruited

2,500+

University of Kansas

Collaborator

Trials

157

Recruited

332,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

References

1. Norway pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of maternal infant-directed reading among hospitalised preterm infants. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Outcomes of population based language promotion for slow to talk toddlers at ages 2 and 3 years: Let's Learn Language cluster randomised controlled trial. [2021]

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

Factors influencing language development in preterm infants. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Parent coaching at 6 and 10 months improves language outcomes at 14 months: A randomized controlled trial. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Parent coaching from 6 to 18 months improves child language outcomes through 30 months of age. [2023]

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

Language skill and interactive patterns in prematurely born toddlers. [2007]

7. England pubmed.ncbi.nlm.nih.gov

A randomised controlled feasibility trial and qualitative evaluation of an early years language development intervention: study protocol of the 'outcomes of Talking Together evaluation and results' (oTTer) project. [2022]

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

Infant communication and subsequent language development in children from low-income families: the role of early cognitive stimulation. [2021]

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

A randomised controlled feasibility trial of an early years language development intervention: results of the 'outcomes of Talking Together evaluation and results' (oTTer) project. [2023]