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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Talk With Me Baby program encourages caregivers to engage more with their infants, thereby enhancing the child's language environment at home. Caregivers will receive the program during regular well-child checkups for young children. Participants will record conversations with their infants before and after the program to measure changes. Families with children aged two to nine months, who attend well-child checkups and can complete the study in English, may qualify for this trial. As an unphased trial, this study offers families a unique opportunity to contribute to research that could improve early childhood language development.

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 prior data suggests that the Talk With Me Baby program is safe for infant language development?

Research has shown that the Talk With Me Baby (TWMB) program aims to improve communication between caregivers and infants. As an educational program, TWMB presents no safety concerns. It is neither a medication nor a medical treatment, so it lacks the side effects or risks associated with drug trials.

The program encourages parents to engage more in conversations with their babies, which can aid brain development and learning. Since it involves simple activities like regular conversations with infants, it is generally safe for all participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

"Talk With Me Baby" is unique because it focuses on enhancing infant language development through verbal interaction, rather than relying on traditional interventions like speech therapy or educational programs aimed at older children. Most treatments for language development involve structured learning environments or professional intervention, but this approach empowers parents and caregivers to engage directly with their infants through everyday conversation. Researchers are excited about this method because it harnesses the natural bond between caregiver and child, potentially leading to more organic and impactful language development outcomes from a very early age.

What evidence suggests that the Talk With Me Baby program is effective for improving infant language development?

Research shows that the Talk With Me Baby (TWMB) program, which participants in this trial will experience, can enhance early language development in babies. Studies have found that babies who hear more directed speech, as encouraged by the TWMB program, better understand familiar words and have larger vocabularies by age two. Strong evidence indicates that the program is widely used and effective. Additionally, coaching for parents, similar to TWMB, has boosted language skills in babies. These findings suggest that the TWMB program could encourage caregivers to talk more to their babies, which is crucial for developing language skills. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/mbe.70007

Talk with Me Baby: Early Language Knowledge Across ... Talk With Me Baby (TWMB) is a program that educates caregivers and professionals on ways to maximize children's early brain and language ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5510534/

Talking to children matters: Early language experience ... Infants who experienced more child-directed speech became more efficient in processing familiar words in real time and had larger expressive vocabularies by 24 ...

3. researchgate.net researchgate.net/publication/394722318_Talk_with_Me_Baby_Early_Language_Knowledge_Across_Disciplines

Talk with Me Baby: Early Language Knowledge Across ... Results reveal an overwhelming support for TWMB with high perceived reach, effectiveness, adoption, implementation, and maintenance, bolstering ...

4. withpower.com withpower.com/trial/phase-speech-6-2024-a1d86

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 ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022096524001206

Early language processing efficiency and pre-literacy ... Early language processing efficiency has been shown to be associated with mechanisms that support learning outcomes in a variety of domains. For example, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06479278

Talk With Me Baby to Enhance the Early Home Language ... 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 ...

7. trialx.com trialx.com/clinical-trials/listings/318312/talk-with-me-baby-to-enhance-the-early-home-language-environment/

Talk With Me Baby to Enhance the Early Home Language ... 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 ...

8. nachc.org nachc.org/resource/talk-with-me-baby-empowering-parents-to-support-babies-brain-development-through-rich-language/

Talk With Me Baby – Empowering Parents to Support ... Talk With Me Baby empowers parents to help their babies build a healthy brain and strong foundation for learning, reading and literacy through the use of good ...

9. psychologytoday.com psychologytoday.com/us/blog/language-in-the-wild/202202/talk-me-baby-improving-your-childs-language-skills

Talk To Me, Baby: Improving Your Child's Language Skills While parents don't "teach" their kids to talk in any traditional sense, infants need a large amount of language data in order to figure out all ...